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

Status:	Completed
Conditions:	Skin Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	10/14/2017
Start Date:	May 2006
End Date:	April 2014

A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.

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.

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

We found this trial at

sites

University of Chicago

5801 South Ellis Avenue
Chicago, Illinois 60637

773.702.1234