Phase 2
Completed N=242
A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies
Source: ClinicalTrials.gov NCT00162123 ↗Enrolled (actual)
242
Serious AEs
43.7%
Results posted
Apr 2014
Primary outcomePrimary: Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome — 51; 33; 24; 18 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome |
51; 33; 24; 18; 10; 10 | — |
| SECONDARY Overall Survival (OS) |
30.8; 18.7; 15.2 | — |
| SECONDARY Percentage of Participants Surviving at 1, 1.5, and 2 Years |
80.9; 55.9; 65.6; 100; 100; 75.0 | — |
| SECONDARY Number of Participants With On-study Immune-related Adverse Events (irAEs) |
30; 23; 18; 7; 2; 6 | — |
| SECONDARY Progression-free Survival (PFS) |
3.4; 2.6; 2.6 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00162123). 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. Informational only — not medical advice.