Brief Summary
This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
Brief Title
Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Head and Neck Neoplasms
Eligibility Criteria
Inclusion Criteria:
* Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries.
* Is eligible for primary surgery based on investigator decision and per local practice
* Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy.
* Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy
* Female participant that is not pregnant or breastfeeding
* Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
* Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Has results from testing of HPV status for oropharyngeal cancer defined as p16
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization
Exclusion Criteria:
* Has Stage T4B and/or N3 locoregionally advanced head and neck squamous cell carcinoma (LA HNSCC) and/or distant metastases
* Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity. such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer (HNC)
* Female participant who has a positive urine pregnancy test within 72 hours prior to study start or within 24 hours prior to the start of radiotherapy with or without cisplatin.
* Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1(PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor
* Has received prior radiotherapy treatment or systemic anti-cancer therapy including investigational agents for the HNC under study prior to study start
* Has received a live vaccine within 30 days prior to randomization
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy
* Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis
* Has Grade ≥2 audiometric hearing loss
* Has Grade ≥2 neuropathy
* Has Grade 3-4 bleeding due to the underlying malignancy
* Has received major surgery or has not recovered adequately from the toxicity and/or complications from the intervention prior to study start
* Has had previous allogeneic tissue/solid organ transplant
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, radiotherapy, cisplatin or their analogs
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of or is positive for Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C (defined as Hepatitis C virus \[HCV\] ribonucleic acid is detected).
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the investigator
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries.
* Is eligible for primary surgery based on investigator decision and per local practice
* Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy.
* Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy
* Female participant that is not pregnant or breastfeeding
* Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
* Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Has results from testing of HPV status for oropharyngeal cancer defined as p16
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization
Exclusion Criteria:
* Has Stage T4B and/or N3 locoregionally advanced head and neck squamous cell carcinoma (LA HNSCC) and/or distant metastases
* Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity. such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer (HNC)
* Female participant who has a positive urine pregnancy test within 72 hours prior to study start or within 24 hours prior to the start of radiotherapy with or without cisplatin.
* Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1(PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor
* Has received prior radiotherapy treatment or systemic anti-cancer therapy including investigational agents for the HNC under study prior to study start
* Has received a live vaccine within 30 days prior to randomization
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy
* Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis
* Has Grade ≥2 audiometric hearing loss
* Has Grade ≥2 neuropathy
* Has Grade 3-4 bleeding due to the underlying malignancy
* Has received major surgery or has not recovered adequately from the toxicity and/or complications from the intervention prior to study start
* Has had previous allogeneic tissue/solid organ transplant
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, radiotherapy, cisplatin or their analogs
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of or is positive for Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C (defined as Hepatitis C virus \[HCV\] ribonucleic acid is detected).
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the investigator
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Inclusion Criteria
Inclusion Criteria:
* Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries.
* Is eligible for primary surgery based on investigator decision and per local practice
* Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy.
* Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy
* Female participant that is not pregnant or breastfeeding
* Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
* Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Has results from testing of HPV status for oropharyngeal cancer defined as p16
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization
* Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries.
* Is eligible for primary surgery based on investigator decision and per local practice
* Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy.
* Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy
* Female participant that is not pregnant or breastfeeding
* Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
* Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Has results from testing of HPV status for oropharyngeal cancer defined as p16
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization
Gender
All
Gender Based
false
Keywords
Programmed Cell Death 1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03765918
Org Class
Industry
Org Full Name
Merck Sharp & Dohme LLC
Org Study Id
3475-689
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
Primary Outcomes
Outcome Description
EFS was based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) and was defined as the time from randomization to any of the following events: radiographic disease progression (RDP; participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in all randomized participants was presented.
Outcome Measure
Event-free Survival (EFS)
Outcome Time Frame
Up to ~66 months
Outcome Description
EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥10 was presented.
Outcome Measure
EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
Outcome Time Frame
Up to ~66 months
Outcome Description
EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥1 was presented.
Outcome Measure
EFS in Participants With PD-L1 CPS ≥1
Outcome Time Frame
Up to ~66 months
Secondary Ids
Secondary Id
MK-3475-689
Secondary Id
2022-500254-41-00
Secondary Id
U1111-1274-2398
Secondary Id
2017-001139-38
Secondary Outcomes
Outcome Description
mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by blinded independent pathologist review (BIPR) at the time of definitive surgery in all randomized participants was presented.
Outcome Time Frame
Up to ~66 months
Outcome Measure
Major Pathological Response (mPR) Rate
Outcome Description
mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery in participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Up to ~66 months
Outcome Measure
mPR Rate in Participants With PD-L1 CPS ≥10
Outcome Description
mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery in participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Up to ~66 months
Outcome Measure
mPR Rate in Participants With PD-L1 CPS ≥1
Outcome Description
pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants was presented.
Outcome Time Frame
Up to ~66 months
Outcome Measure
Pathological Complete Response (pCR) Rate
Outcome Description
pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Up to ~66 months
Outcome Measure
pCR Rate in Participants With PD-L1 CPS ≥10
Outcome Description
pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Up to ~66 months
Outcome Measure
pCR Rate in Participants With PD-L1 CPS ≥1
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Scale Combined Score at Week 4
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 4
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QOL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 4
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 6
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 6
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 6
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 25
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 25
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 25
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 51
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 51
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 51
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 4
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 4
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 4
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 6
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 6
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 6
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 25
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 25
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 25
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 51
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 51
Outcome Description
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 51
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-Head and Neck Module 35 [H&N35] (Items 35-38) Swallowing Combined Score at Week 4
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 4
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 4
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 6
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 6
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 6
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 25
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 25
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 25
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 51
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 51
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 51
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 4
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 4
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 4
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 6
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 6
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 6
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 25
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 25
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 25
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 51
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 51
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 51
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 4
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 4
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 4
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 4
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 6
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 6
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented.
Outcome Time Frame
Baseline and Week 6
Outcome Measure
Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 6
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 25
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 25
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Baseline and Week 25
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 25
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 51
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 51
Outcome Description
EORTC QLQ-H\&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H\&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Baseline and Week 51
Outcome Measure
Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 51
Outcome Description
OS was defined as the time from randomization to death due to any cause. OS for all randomized participants was presented.
Outcome Time Frame
Up to ~92 months
Outcome Measure
Overall Survival (OS)
Outcome Description
OS was defined as the time from randomization to death due to any cause. OS for all randomized participants with PD-L1 CPS ≥10 was presented.
Outcome Time Frame
Up to ~92 months
Outcome Measure
OS in Participants With PD-L1 CPS ≥10
Outcome Description
OS was defined as the time from randomization to death due to any cause. OS for all randomized participants with PD-L1 CPS ≥1 was presented.
Outcome Time Frame
Up to ~92 months
Outcome Measure
OS in Participants With PD-L1 CPS ≥1
Outcome Description
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who experienced one or more AEs was reported.
Outcome Time Frame
Up to ~92 months
Outcome Measure
Number of Participants Who Experienced an Adverse Event (AE)
Outcome Description
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who discontinued study treatment due to an AE was reported.
Outcome Time Frame
Up to ~92 months
Outcome Measure
Number of Participants Who Discontinued Study Treatment Due to an AE
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Balazs Halmos
Investigator Email
bahalmos@montefiore.org
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Endocrine System Cancers --- HEAD AND NECK NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
MeSH Terms
HEAD AND NECK NEOPLASMS
PARKINSON DISEASE 4, AUTOSOMAL DOMINANT LEWY BODY
NEOPLASMS BY SITE
NEOPLASMS
PEMBROLIZUMAB
CISPLATIN
CHLORINE COMPOUNDS
INORGANIC CHEMICALS
NITROGEN COMPOUNDS
PLATINUM COMPOUNDS