Brief Summary
To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment
Brief Title
Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
Detailed Description
Condition: Ovarian Cancer, Second line, Third line, or Fourth line
Completion Date
Completion Date Type
Actual
Conditions
Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
Eligibility Criteria
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Key Inclusion Criteria
* Ovarian cancer that is not refractory or resistant to platinum-based therapy (refactory=progression while receiving any previous platinum regimen; resistant=progression within 6 months of any previous platinum regimen)
* Recipients of platinum/taxane-based chemotherapy as frontline regimen for ovarian cancer
* An Eastern Cooperative Oncology Group performance status ≤1
* Up to 4 prior lines of therapy for ovarian cancer
* Two groups are eligible:
Group 1. Women who have not met the criteria for progressive disease following their most recent chemotherapeutic regimen were required to have:
* Demonstrated partial response or stable disease following the most recent chemotherapy regimen
* Evaluable or measurable disease, detected by baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan
* Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer within 4 to 12 weeks of the first administration of ipilimumab Group 2: Women with disease progression while receiving or following the last dose of the most recent chemotherapeutic regimen were required to have:
* Measurable disease on a CT or MRI scan performed within 28 days of first dose of ipilimumab.
* Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer at least 4 weeks prior to the first administration of ipilimumab.
Key Exclusion Criteria
* Histologic diagnosis of borderline, low malignant potential epithelial carcinoma
* For Group 1, women with complete response on the most recent ovarian carcinomatherapy
* Presence of known brain metastases
* Second malignancy active within the past 5 years, with the exception of locally curable cancers that have no need for subsequent therapy
* Documented history of severe autoimmune or immune-mediated symptomatic disease requiring prolonged systemic immunosuppressive treatment
* History of motor neuropathy considered to be of autoimmune origin or the of grade 2 or higher peripheral neuropathy
* History of toxic epidermal necrolysis
* Prior therapies with immunosuppressive agents within the last 2 years (excluding low-dose corticosteroids) and prior therapies with cytotoxic drugs within 4 weeks
* Chronic use of systemic immunosuppressive drugs, ongoing use of immunotherapy or biologic therapy for the treatment of cancer, or prior use of ipilimumab or any immune-stimulating agent.
Key Inclusion Criteria
* Ovarian cancer that is not refractory or resistant to platinum-based therapy (refactory=progression while receiving any previous platinum regimen; resistant=progression within 6 months of any previous platinum regimen)
* Recipients of platinum/taxane-based chemotherapy as frontline regimen for ovarian cancer
* An Eastern Cooperative Oncology Group performance status ≤1
* Up to 4 prior lines of therapy for ovarian cancer
* Two groups are eligible:
Group 1. Women who have not met the criteria for progressive disease following their most recent chemotherapeutic regimen were required to have:
* Demonstrated partial response or stable disease following the most recent chemotherapy regimen
* Evaluable or measurable disease, detected by baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan
* Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer within 4 to 12 weeks of the first administration of ipilimumab Group 2: Women with disease progression while receiving or following the last dose of the most recent chemotherapeutic regimen were required to have:
* Measurable disease on a CT or MRI scan performed within 28 days of first dose of ipilimumab.
* Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer at least 4 weeks prior to the first administration of ipilimumab.
Key Exclusion Criteria
* Histologic diagnosis of borderline, low malignant potential epithelial carcinoma
* For Group 1, women with complete response on the most recent ovarian carcinomatherapy
* Presence of known brain metastases
* Second malignancy active within the past 5 years, with the exception of locally curable cancers that have no need for subsequent therapy
* Documented history of severe autoimmune or immune-mediated symptomatic disease requiring prolonged systemic immunosuppressive treatment
* History of motor neuropathy considered to be of autoimmune origin or the of grade 2 or higher peripheral neuropathy
* History of toxic epidermal necrolysis
* Prior therapies with immunosuppressive agents within the last 2 years (excluding low-dose corticosteroids) and prior therapies with cytotoxic drugs within 4 weeks
* Chronic use of systemic immunosuppressive drugs, ongoing use of immunotherapy or biologic therapy for the treatment of cancer, or prior use of ipilimumab or any immune-stimulating agent.
Inclusion Criteria
Inclusion Criteria
* Ovarian cancer that is not refractory or resistant to platinum-based therapy (refactory=progression while receiving any previous platinum regimen; resistant=progression within 6 months of any previous platinum regimen)
* Recipients of platinum/taxane-based chemotherapy as frontline regimen for ovarian cancer
* An Eastern Cooperative Oncology Group performance status ≤1
* Up to 4 prior lines of therapy for ovarian cancer
* Two groups are eligible:
Group 1. Women who have not met the criteria for progressive disease following their most recent chemotherapeutic regimen were required to have:
* Demonstrated partial response or stable disease following the most recent chemotherapy regimen
* Evaluable or measurable disease, detected by baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan
* Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer within 4 to 12 weeks of the first administration of ipilimumab Group 2: Women with disease progression while receiving or following the last dose of the most recent chemotherapeutic regimen were required to have:
* Measurable disease on a CT or MRI scan performed within 28 days of first dose of ipilimumab.
* Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer at least 4 weeks prior to the first administration of ipilimumab.
* Ovarian cancer that is not refractory or resistant to platinum-based therapy (refactory=progression while receiving any previous platinum regimen; resistant=progression within 6 months of any previous platinum regimen)
* Recipients of platinum/taxane-based chemotherapy as frontline regimen for ovarian cancer
* An Eastern Cooperative Oncology Group performance status ≤1
* Up to 4 prior lines of therapy for ovarian cancer
* Two groups are eligible:
Group 1. Women who have not met the criteria for progressive disease following their most recent chemotherapeutic regimen were required to have:
* Demonstrated partial response or stable disease following the most recent chemotherapy regimen
* Evaluable or measurable disease, detected by baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan
* Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer within 4 to 12 weeks of the first administration of ipilimumab Group 2: Women with disease progression while receiving or following the last dose of the most recent chemotherapeutic regimen were required to have:
* Measurable disease on a CT or MRI scan performed within 28 days of first dose of ipilimumab.
* Received the last dose of their most recent chemotherapeutic regimen for ovarian cancer at least 4 weeks prior to the first administration of ipilimumab.
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01611558
Org Class
Industry
Org Full Name
Bristol-Myers Squibb
Org Study Id
CA184-201
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects
Primary Outcomes
Outcome Description
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-threatening or disabling.
Outcome Measure
Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher
Outcome Time Frame
Day 1, first dose, to within 90 days of last dose in Induction Phase
Secondary Outcomes
Outcome Description
BORR is defined as the percentage of participants who received treatment and, at any time during the study, had a best response of complete response or partial response, as confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria for patients with cancer antigen 125 (CA125) levels elevated to twice the upper limit of normal at baseline, divided by the total number of evaluable participants in the arm.
Outcome Time Frame
From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years)
Outcome Measure
Best Overall Response Rate (BORR)
Outcome Description
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
Outcome Time Frame
From first dose to within 90 days of last study dose
Outcome Measure
Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related AEs, AEs Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
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
Dennis Yi-Shin Kuo
Investigator Email
DYKUO@montefiore.org
Investigator Phone
718-405-8086
MeSH Terms
IPILIMUMAB
ANTIBODIES, MONOCLONAL, HUMANIZED
ANTIBODIES, MONOCLONAL
ANTIBODIES
IMMUNOGLOBULINS
IMMUNOPROTEINS
BLOOD PROTEINS
PROTEINS
AMINO ACIDS, PEPTIDES, AND PROTEINS
SERUM GLOBULINS
GLOBULINS