Brief Summary
The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B).
In Part A (enrollment closed), each participant was assigned to one of three study treatment groups.
* One group is given sasanlimab and BCG at the study clinic.
* The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only.
* The third group is given BCG only and will not receive sasanlimab.
In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor.
\- Both groups will be given sasanlimab at the study clinic.
On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.
In Part A (enrollment closed), each participant was assigned to one of three study treatment groups.
* One group is given sasanlimab and BCG at the study clinic.
* The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only.
* The third group is given BCG only and will not receive sasanlimab.
In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor.
\- Both groups will be given sasanlimab at the study clinic.
On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.
Brief Title
A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
Detailed Description
CREST: Combination of sasanlimab and alternative BCG Regimens to Evaluate outcomes with Subcutaneous anti-PD-1 Treatment
Phase 3 Design with two Cohorts. Cohort A consists of 3 study Arms (A, B and C) of BCG naive participants. Arms A and B consist of two study drugs, PF-06801591 plus BCG. Arm C consists of one study drug, BCG. Cohort B consists of B1 and B2, which test PF-06801591 and include participants who have BCG unresponsive CIS (B1) or BCG unresponsive papillary only disease (B2).
The study is designed to demonstrate that PF-06801591 plus Bacillus Calmette Guerin (BCG) (induction and maintenance periods) is superior to BCG alone (induction and maintenance periods) in prolonging event free survival (EFS) in participants with high-risk naïve non-muscle invasive bladder cancer (NMIBC) and to demonstrate that PF-06801591 plus BCG (induction period only) is superior to BCG alone (induction and maintenance periods) in prolonging EFS in participants with high-risk NMIBC. The study is also designed to estimate the CR rate of PF-06801591 alone in participants with BCG unresponsive CIS and to evaluate the EFS of PF-06801591 alone in participants with BCG unresponsive NMIBC.
On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B, which enrolled participants with BCG unresponsive NMIBC. The decision to discontinue enrollment to Part B was not made for safety reasons.
Phase 3 Design with two Cohorts. Cohort A consists of 3 study Arms (A, B and C) of BCG naive participants. Arms A and B consist of two study drugs, PF-06801591 plus BCG. Arm C consists of one study drug, BCG. Cohort B consists of B1 and B2, which test PF-06801591 and include participants who have BCG unresponsive CIS (B1) or BCG unresponsive papillary only disease (B2).
The study is designed to demonstrate that PF-06801591 plus Bacillus Calmette Guerin (BCG) (induction and maintenance periods) is superior to BCG alone (induction and maintenance periods) in prolonging event free survival (EFS) in participants with high-risk naïve non-muscle invasive bladder cancer (NMIBC) and to demonstrate that PF-06801591 plus BCG (induction period only) is superior to BCG alone (induction and maintenance periods) in prolonging EFS in participants with high-risk NMIBC. The study is also designed to estimate the CR rate of PF-06801591 alone in participants with BCG unresponsive CIS and to evaluate the EFS of PF-06801591 alone in participants with BCG unresponsive NMIBC.
On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B, which enrolled participants with BCG unresponsive NMIBC. The decision to discontinue enrollment to Part B was not made for safety reasons.
Completion Date
Completion Date Type
Estimated
Conditions
Non-muscle Invasive Bladder Cancer
Eligibility Criteria
Inclusion Criteria:
* Histological confirmed diagnosis of high risk non-muscle invasive transitional cell carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed transitional/non-transitional cell histology are allowed, but TCC must be the predominant histology)
* Complete resection of all Ta/T1 papillary disease (including participants with concurrent CIS), with most recent positive TURBT occurring within 12 weeks prior to randomization or study intervention. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology
* (Cohorts B1 and B2 only): Histological confirmed diagnosis of BCG-unresponsive high-risk, non-muscle invasive TCC of the urothelium within 12 months (CIS only) or 6 months (recurrent Ta/T1 disease) of completion of adequate BCG therapy.
* Have refused or are ineligible for radical cystectomy
Exclusion Criteria:
* Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or concurrent extravesical, non-muscle invasive TCC of the urothelium
* (Cohort A only): Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical chemotherapy for NMIBC is allowed.
(Cohorts B1 and B2 only): Any systemic or intravesical chemotherapy or immunotherapy from the time of most recent positive TURBT to initiation of study intervention.
* Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
* Prior treatment with immunostimulatory agents including interleukin (IL)-2, IL-15, interferon (INF)
* Prior radiation therapy to the bladder
* (Cohorts B1 and B2 only): Prior participation in Cohort A of this study.
* Histological confirmed diagnosis of high risk non-muscle invasive transitional cell carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed transitional/non-transitional cell histology are allowed, but TCC must be the predominant histology)
* Complete resection of all Ta/T1 papillary disease (including participants with concurrent CIS), with most recent positive TURBT occurring within 12 weeks prior to randomization or study intervention. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology
* (Cohorts B1 and B2 only): Histological confirmed diagnosis of BCG-unresponsive high-risk, non-muscle invasive TCC of the urothelium within 12 months (CIS only) or 6 months (recurrent Ta/T1 disease) of completion of adequate BCG therapy.
* Have refused or are ineligible for radical cystectomy
Exclusion Criteria:
* Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or concurrent extravesical, non-muscle invasive TCC of the urothelium
* (Cohort A only): Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical chemotherapy for NMIBC is allowed.
(Cohorts B1 and B2 only): Any systemic or intravesical chemotherapy or immunotherapy from the time of most recent positive TURBT to initiation of study intervention.
* Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
* Prior treatment with immunostimulatory agents including interleukin (IL)-2, IL-15, interferon (INF)
* Prior radiation therapy to the bladder
* (Cohorts B1 and B2 only): Prior participation in Cohort A of this study.
Inclusion Criteria
Inclusion Criteria:
* Histological confirmed diagnosis of high risk non-muscle invasive transitional cell carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed transitional/non-transitional cell histology are allowed, but TCC must be the predominant histology)
* Complete resection of all Ta/T1 papillary disease (including participants with concurrent CIS), with most recent positive TURBT occurring within 12 weeks prior to randomization or study intervention. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology
* (Cohorts B1 and B2 only): Histological confirmed diagnosis of BCG-unresponsive high-risk, non-muscle invasive TCC of the urothelium within 12 months (CIS only) or 6 months (recurrent Ta/T1 disease) of completion of adequate BCG therapy.
* Have refused or are ineligible for radical cystectomy
* Histological confirmed diagnosis of high risk non-muscle invasive transitional cell carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed transitional/non-transitional cell histology are allowed, but TCC must be the predominant histology)
* Complete resection of all Ta/T1 papillary disease (including participants with concurrent CIS), with most recent positive TURBT occurring within 12 weeks prior to randomization or study intervention. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology
* (Cohorts B1 and B2 only): Histological confirmed diagnosis of BCG-unresponsive high-risk, non-muscle invasive TCC of the urothelium within 12 months (CIS only) or 6 months (recurrent Ta/T1 disease) of completion of adequate BCG therapy.
* Have refused or are ineligible for radical cystectomy
Gender
All
Gender Based
false
Keywords
CREST
Sasanlimab
PF-06801591
Bacillus Calmette Guerin
BCG
Bladder cancer
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04165317
Org Class
Industry
Org Full Name
Pfizer
Org Study Id
B8011006
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC
Primary Outcomes
Outcome Description
EFS: time from randomization till recurrence of high-grade disease, progression of disease, persistence of carcinoma in situ (CIS), death due to any cause, whichever occurred first. Recurrence of high-grade disease: re-appearance of high-grade disease after randomization/study intervention initiation, re-appearance of high-grade disease after complete response (CR) for CIS participants or re-appearance of high-grade disease before CR for CIS participants and concurrent papillary disease at baseline. Progression of disease defined as any of following: Lamina propria invasion, muscle invasive disease, lymph node positive disease, metastatic disease, high-grade stage of bladder cancer (non-invasive papillary carcinoma \[Ta\] or invasion into the lamina propria without invasion into the muscularis propria \[T1\]) in participants with CIS only at baseline before achieving CR. Persistence of CIS: persistent CIS after induction, re-induction. EFS estimated using Kaplan-Meier analysis.
Outcome Measure
Cohort A: Event Free Survival (EFS) as Assessed by the Investigator: Arm A Versus Arm C
Outcome Time Frame
From randomization (Day 1) to first documentation of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first (maximum follow up duration was up to 257.1 weeks)
Secondary Ids
Secondary Id
CREST
Secondary Id
2023-509089-39-00
Secondary Outcomes
Outcome Description
EFS: time from randomization till recurrence of high-grade disease, progression of disease, CIS, death due to any cause, whichever occurred first. Recurrence of high-grade disease: re-appearance of high-grade disease after randomization/study intervention initiation, re-appearance of high-grade disease after CR for CIS participants or re-appearance of high-grade disease before CR for CIS participants and concurrent papillary disease at baseline. Progression of disease defined as any of following: Lamina propria invasion, muscle invasive disease, lymph node positive disease, metastatic disease, high-grade stage of bladder cancer (non-invasive papillary carcinoma \[Ta\] or invasion into the lamina propria without invasion into the muscularis propria \[T1\]) in participants with CIS only at baseline before achieving CR. Persistence of CIS: persistent CIS after induction, re-induction. EFS estimated using Kaplan-Meier analysis.
Outcome Time Frame
From randomization (Day 1) to the first documentation of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first (maximum follow up duration was up to 257.1 weeks)
Outcome Measure
Cohort A: EFS as Assessed by the Investigator: Arm B Versus Arm C
Outcome Description
Overall survival was defined as the time in months from the date of randomization to the date of death due to any cause. Participants last known to be alive will be censored at the date of last contact
Outcome Time Frame
From randomization (Day 1) until date of death due to any cause or censoring date
Outcome Measure
Cohort A: Overall Survival (OS) for Participants: Arm A Versus Arm C
Outcome Description
Overall survival was defined as the time in months from the date of randomization to the date of death due to any cause. Participants last known to be alive will be censored at the date of last contact.
Outcome Time Frame
From randomization (Day 1) until date of death due to any cause or censoring date
Outcome Measure
Cohort A: OS of Participants: Arm B Versus Arm C
Outcome Description
CR was defined as histologic disappearance of malignancy on bladder biopsy with negative cytology and cystoscopy or negative cytology and positive cystoscopy with biopsy-proven low-grade stage of bladder cancer defined as a non-invasive papillary carcinoma (Ta) lesion or non-malignant tissue for participants with CIS at randomization. 95% CI was based on Clopper-Pearson method.
Outcome Time Frame
From randomization (Day 1) to the first documented CR (maximum follow up duration was up to 257.1 weeks)
Outcome Measure
Cohort A: Percentage of Participants With Complete Response (CR)as Assessed by Investigator: Participants With CIS at Baseline in Full Analysis Set
Outcome Description
Duration of CR was defined as the time from the first documentation of CR to the date of an EFS event for participants with CR. EFS was defined as the time in months from randomization until recurrence of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first. CR was defined as histologic disappearance of malignancy on bladder biopsy with negative cytology and cystoscopy or negative cytology and positive cystoscopy with biopsy-proven low-grade stage of bladder cancer defined as a non-invasive papillary carcinoma (Ta) lesion or non-malignant tissue for participants with CIS at randomization. Kaplan-Meier method was used. 95% CI was estimated based on Brookmeyer and Crowley method.
Outcome Time Frame
From date of first documentation of CR to date of an EFS event (maximum follow up duration was up to 257.1 weeks)
Outcome Measure
Cohort A: Duration of CR as Assessed by the Investigator: Participants With CIS at Baseline in Full Analysis Set
Outcome Description
Time to recurrence of low-grade disease was defined as the time from randomization to the date of first documentation of recurrence of low-grade disease. Recurrence of low-grade disease was defined as re-appearance of low-grade disease (low-grade Ta) after randomization based on positive biopsy, cystoscopy or cytology result. Kaplan-Meier method was used. 95% CI was estimated based on Brookmeyer and Crowley method.
Outcome Time Frame
From randomization (Day 1) to the date of positive biopsy, cystoscopy or cytology results (maximum follow up duration was up to 257.1 weeks)
Outcome Measure
Cohort A: Time to Recurrence of Low-Grade Disease Assessed by the Investigator
Outcome Description
Time to cystectomy was defined as time from randomization to cystectomy. Participants without a cystectomy will be censored at death date or last date known to be alive.
Outcome Time Frame
From randomization (Day 1) to date of cystectomy or censoring date
Outcome Measure
Cohort A: Time to Cystectomy
Outcome Description
DSS was defined as the time from randomization to death resulting from bladder cancer, as assessed by the investigator. Participants last known to be alive will be censored at the date of last contact.
Outcome Time Frame
From randomization (Day 1) to the first documentation of death from bladder cancer
Outcome Measure
Cohort A: Disease Specific Survival (DSS) as Assessed by the Investigator
Outcome Description
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as the time from the first dose of study treatment up to 30 days after last dose of study treatment or 1 day before start day of new anti-cancer therapy.
Outcome Time Frame
From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment or 1 day before anti-cancer therapy
Outcome Measure
Cohort A: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Outcome Description
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as the time from the first dose of study treatment up to 30 days after last dose of study treatment or 1 day before start day of new anti-cancer therapy. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death or was life threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or other events.
Outcome Time Frame
From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment or 1 day before anti-cancer therapy
Outcome Measure
Cohort A: Number of Participants With Serious TEAEs
Outcome Description
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as the time from the first dose of study treatment up to 30 days after last dose of study treatment or 1 day before start day of new anti-cancer therapy. A SAE was any untoward medical occurrence at any dose that: resulted in death or was life threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity resulted in congenital anomaly/birth defect or other events. Relatedness was based on the investigator's judgement.
Outcome Time Frame
From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment or 1 day before anti-cancer therapy
Outcome Measure
Cohort A: Number of Participants With Treatment Related TEAEs and Treatment Related SAEs
Outcome Description
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as the time from the first dose of study treatment up to 30 days after last dose of study treatment or 1 day before start day of new anti-cancer therapy. NCI-CTCAE version 5.0, severity was graded as Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe and Grade 4 Life threatening and Grade 5: Death.
Outcome Time Frame
From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment or 1 day before anti-cancer therapy
Outcome Measure
Cohort A: Number of Participant With Grade 3 or 4 and Grade 5 TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Outcome Description
Laboratory parameters: hematocrit, hemoglobin, platelets, white blood cells, absolute neutrophil count, lymphocytes, monocytes, eosinophils, basophils, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium and bilirubin, blood urea nitrogen, urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus/phosphate, lipase, amylase, thyroid function test + reflex free thyroxine, free triiodothyronine, adrenocorticotropic hormone, international normalized ratio, partial thromboplastin time (PTT)/activated PTT, hepatitis B surface antigen, hepatitis C virus antibody. Severity grades per NCI-CTCAE v5.0: 1: Mild, 2: Moderate, 3: Severe, 4: Life threatening,5: Death.
Outcome Time Frame
From first dose of study treatment (Day 1) up to 30 days after last dose of study treatment or 1 day before anti-cancer therapy
Outcome Measure
Cohort A: Number of Participant With Laboratory Abnormalities as Based on Severity (as Graded by NCI CTCAE v5.0)
Outcome Description
The EORTC QLQ-C30 was a 30 self-administered questionnaire, which comprised of 5 functional domain subscales (physical functioning subscale, a role functioning subscale, an emotional functioning subscale, a cognitive functioning subscale and a social functioning subscale), 3 symptom scale (fatigue, pain, nausea and vomiting), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. All the scales and single-item measures range in score from 0 (poor functioning/no symptoms) to 100 (excellent functioning/greater degree of symptoms). Higher scores on functional domains indicated higher levels of functioning and higher scores on symptom scale/single items indicated greater presence of symptoms.
Outcome Time Frame
Baseline up to recurrence of high-grade disease or disease progression, consent withdrawal, lost to follow-up, or death
Outcome Measure
Cohort A: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Non-Muscle Invasive Bladder Cancer (QLQ-C) 30 Total Score
Outcome Description
The EORTC QLQ NMIBC24 is a PRO developed and tested by the EORTC group specifically for participants with non-muscle invasive bladder cancer. The NMIBC24 has 24 items which can be grouped into 6 subscales: urinary symptoms (7 items), malaise (2 items), future worries (4 items), bloating/flatulence (2 items), sexual functioning (2 items), and male sexual issues (2 items). The NMIBC24 also assesses intravesical treatment, female sexual issues, sexual intimacy, risk of contaminating a partner, and sexual enjoyment (1 item each). All of the subscales and single-item measures range in score from 0 (poor functioning/no symptoms) to 100 (excellent functioning/greater degree of symptoms). Higher scores indicate greater impairment, except for sexual function and sexual enjoyment items, where higher scores indicate better function.
Outcome Time Frame
Baseline up to recurrence of high-grade disease or disease progression, consent withdrawal, lost to follow-up, or death
Outcome Measure
Cohort A: Change From Baseline in EORTC QLQ- Non-Muscle Invasive Bladder Cancer (NMIBC24) Total Score
Outcome Description
The PTAB questionnaire was a 2-item PRO designed to assess, from the participant perspective, any pain associated with the treatment administration and the burden of the amount of time required to complete the treatment administration procedures (1 item each). The items were scored on a range of 0 to 4, where 0=no pain/ not at all burdensome and 4= extremely severe pain/ extremely burdensome.
Outcome Time Frame
Baseline up to 7 days after last dose of study treatment
Outcome Measure
Cohort A: Change From Baseline in Patient Treatment Administration Burden (PTAB) Questionnaire Total Score
Outcome Description
Concentration at Trough is defined as Predose/trough concentration Observed directly from data.
Outcome Time Frame
Pre-dose on Day 1 of Cycles 1, 2, 4, 6, 8, 10 and 13 (1 cycle=4 weeks)
Outcome Measure
Cohort A: Concentration at Trough (Ctrough) of PF-06801591 for Arms A and B Only
Outcome Description
A participant was considered ADA (or NAb) positive if (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-fold dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted).
Outcome Time Frame
From start of study treatment (Day 1) until 7 days after last dose of study treatment (maximum up to 125.1 weeks and 104.4 weeks of treatment exposure for Arm A and Arm B, respectively)
Outcome Measure
Cohort A: Number of Participants With Positive (Anti-Drug Antibody) ADA or (Neutralizing Antibody) NAb: Arms A and B Only
Outcome Description
PD-L1 expression was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and immune cells in regions of interest that were defined by tumor cell morphology. PDL-1 status was high if \>=25% tumor cell or (immune cells present in the tumor area \> 1% and PD-L1 positive immune cells+ \>=25%) or (immune cells present in the tumor area = 1% and PD-L1 positive immune cells = 100%), and low if \< 25% tumor cell and \[(immune cells present in the tumor area \> 1% and immune cells \<25%) or (immune cells present in the tumor area = 1% and PD-L1 positive immune cells\< 100%) or immune cells present = 0\].
Outcome Time Frame
From start of study treatment (Day 1) until 7 days after last dose of study treatment (maximum up to 125.1 weeks, 104.4 weeks and 110 weeks of treatment exposure for Arm A, Arm B and Arm C, respectively)
Outcome Measure
Cohort A: Number of Participants According to Tumor Sample Biomarker Status Based on Baseline Programmed Cell Death Ligand 1 (PD-L1) Expression
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
Benjamin Gartrell
Investigator Email
bgartrel@montefiore.org
Investigator Phone
718-405-8404
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Cancer --- CARCINOMA
Lung & Chest Cancers --- NEOPLASMS, GLANDULAR AND EPITHELIAL
Cancer --- NEOPLASMS
Prostate Cancer --- UROGENITAL NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Kidney & Urinary Tract --- URINARY BLADDER DISEASES
Kidney & Urinary Tract --- UROLOGIC DISEASES
MeSH Terms
NON-MUSCLE INVASIVE BLADDER NEOPLASMS
URINARY BLADDER NEOPLASMS
CARCINOMA
NEOPLASMS, GLANDULAR AND EPITHELIAL
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
UROLOGIC NEOPLASMS
UROGENITAL NEOPLASMS
NEOPLASMS BY SITE
FEMALE UROGENITAL DISEASES
FEMALE UROGENITAL DISEASES AND PREGNANCY COMPLICATIONS
UROGENITAL DISEASES
URINARY BLADDER DISEASES
UROLOGIC DISEASES
MALE UROGENITAL DISEASES
BCG VACCINE
TUBERCULOSIS VACCINES
BACTERIAL VACCINES
VACCINES
BIOLOGICAL PRODUCTS
COMPLEX MIXTURES