Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment

Detailed Description
-----------------
Condition: Ovarian Cancer, Second line, Third line, or Fourth line

Official Title
-----------------
A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects

Conditions
-----------------
Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line

Intervention / Treatment
-----------------
* Biological: Ipilimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm: Ipilimumab, 10 mg/kg<br>Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs. | Biological: Ipilimumab<br> <br> * Other names: BMS-734016;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher | 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. | Day 1, first dose, to within 90 days of last dose in Induction Phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall Response Rate (BORR) | 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. | From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years) | 
| 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 | 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. | From first dose to within 90 days of last study dose |