Phase 3
N=951
Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma
High Risk Stage III Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00636168 ↗Enrolled (actual)
951
Serious AEs
40.7%
Results posted
Aug 2014
Primary outcome: Primary: Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population — 26.09; 17.05 months — p=0.0013
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ipilimumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population |
26.09; 17.05 | 0.0013 sig |
| PRIMARY Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population |
234; 294 | — |
| PRIMARY Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population |
63.50; 56.13; 51.45; 43.83; 46.48; 34.79 | — |
| SECONDARY Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population |
48.30; 27.47 | 0.0024 sig |
| SECONDARY Number of Participants With Distant Metastasis-Free Survival (DMFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population |
227; 279 | — |
| SECONDARY Distant Metastasis-Free Survival (DMFS) Rates Per IRC at 1 Year, 2 Years, 3 Years, 4 Years and 5 Years in the ITT Population |
74.27; 65.77; 61.48; 53.26; 53.90; 45.17 | — |
| SECONDARY Overall Survival in the Intent to Treat (ITT) Population |
86.60; NA | 0.0013 sig |
| SECONDARY Rate of Overall Survival (OS) |
93.53; 87.72; 82.55; 75.27; 74.20; 65.43 | — |
| SECONDARY Number of Participants With On-Study Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population |
247; 43; 257; 128; 217; 10 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Non-serious AEs (NSAEs) and Number of Deaths: Overall Study |
173; 223; 257; 128; 441; 382 | — |
| SECONDARY Exposure Adjusted Incidence Rate of Adverse Events Including Multiple Occurrences of Unique Events |
1171.8; 465.0 | — |
| SECONDARY Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint |
-2.29; 1.33; -6.64; -0.10; -9.06; -0.23 | — |
Summary
The purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection of high risk stage III melanoma
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria
- Age ≥ 18 years
- Complete and adequate resection of Stage III melanoma with histologically confirmed melanoma metastatic to lymph node
- Disease-free
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Randomization within 12 weeks of surgery
Exclusion Criteria
- Prior therapy for melanoma except surgery
- Auto-immune disease
Data sourced from ClinicalTrials.gov (NCT00636168). 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.