Phase 2
N=40
Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum-sensitive Ovarian Cancer
Platinum-sensitive Ovarian Cancer, Second-line, Third-line, or Fourth-line
Bottom Line
View on ClinicalTrials.gov: NCT01611558 ↗Enrolled (actual)
40
Serious AEs
65.0%
Results posted
Apr 2016
Primary outcome: Primary: Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher — 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ipilimumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher |
20 | — |
| SECONDARY Best Overall Response Rate (BORR) |
15.0 | — |
| SECONDARY 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 |
35; 26; 16; 38; 16 | — |
Summary
To assess the incidence of drug-related adverse events of Grade 3 or higher and the overall response associated with ipilimumab treatment
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.
Data sourced from ClinicalTrials.gov (NCT01611558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.