This trial is active, not recruiting.

Condition ovarian cancer
Treatment ipilimumab
Phase phase 2
Target CTLA-4
Sponsor Bristol-Myers Squibb
Start date August 2012
End date August 2014
Trial size 40 participants
Trial identifier NCT01611558, CA184-201


To assess the incidence of drug-related adverse events of Grade 3 or higher during the induction period of Ipilimumab.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Intravenous (IV) solution, IV, 10 mg/kg, Once every 3 weeks for 4 doses; then once every 12 weeks starting at Week 24, Until disease progression or unacceptable toxicity (for a maximum treatment period of 3 years from the first dose)
ipilimumab Yervoy

Primary Outcomes

Incidence of drug-related adverse events of grade 3 or higher during the induction period of Ipilimumab
time frame: Up to Week 24

Secondary Outcomes

Best overall response rate (BORR)
time frame: Weeks, 6, 12, 18, and 24 during induction phase, and every 12 weeks during maintenance phase until Progressive Disease (PD) by RECIST v1.1

Eligibility Criteria

Female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Recurrent Platinum Sensitive - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Exclusion Criteria: - Platinum Refractory ovarian cancer - More than 4 lines of prior therapy

Additional Information

Official title A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy Following Completion of Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects With Residual Measurable Disease
Description Condition: Ovarian Cancer, Second Line, Third Line, or Fourth Line
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.