Clinical trial · Interventional
Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects
NCT01611558CI-TRIAL-00045919completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line | Platinum-Sensitive Ovarian Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm: Ipilimumab, 10 mg/kg
- 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.
- interventionNames
- Biological: Ipilimumab
Primary outcomes (1)
- measure
- Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher
- timeFrame
- Day 1, first dose, to within 90 days of last dose in Induction Phase
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.