A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Ipilimumab

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria

• Diagnosis of advanced melanoma

• Prior treatment in a prespecified prior/parent ipilimumab study

• Men and women 18 years of age and older

First Reinduction:

• No unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation

• Had experienced documented progressive disease after expanded clinical benefit

Extended Maintenance

• Received ipilimumab at any dose in a parent study

• Achieved expanded clinical benefit at the time of entry to current study

Follow-up:

• Received ipilimumab at any dose in a closing parent study

• Deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up

Key Exclusion Criteria

• Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab

• Primary ocular or mucosal melanoma