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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

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

Treatments: Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01611558

CA184-201

Details and patient eligibility

About

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

Full description

Condition: Ovarian Cancer, Second line, Third line, or Fourth line

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Arm: Ipilimumab, 10 mg/kg

Experimental group

Description:

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.

Treatment:

Biological: Ipilimumab