Phase 3
N=906
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT02388906 ↗Enrolled (actual)
906
Serious AEs
35.5%
Results posted
Jun 2021
Primary outcome: Primary: Recurrence-free Survival (RFS) — 52.37; 24.08 Months — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ipilimumab (Drug); Nivolumab (Drug); Placebo matching Ipilimumab (Other); Placebo matching Nivolumab (Other)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence-free Survival (RFS) |
61.14; 24.15 | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events |
116; 251; 440; 446 | — |
| SECONDARY The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events |
48; 145; 80; 184 | — |
| SECONDARY the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths |
128; 142 | — |
| SECONDARY The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities |
114; 148; 0; 2; 27; 25 | — |
| SECONDARY Recurrence-free Survival by PD-L1 Expression |
70.41; 54.67; 38.677; 16.56 | — |
| SECONDARY Health Related Quality of Life (HRQoL) Evaluation |
-2.04; -4.88; -2.43; -3.85; 0.18; 1.43 | — |
Summary
The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.
Eligibility Criteria
Inclusion Criteria
- At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects < 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is ≥ 18 years of age
- Completely removed melanoma by surgery performed within 12 weeks of randomization
- Stage IIIb/C or Stage IV before complete resection
- No previous anti-cancer treatment
Exclusion Criteria
- Ocular or uveal melanoma
- History of carcinomatosis meningitis
- History of auto-immune disease
- Treatment directed against the resected melanoma that is administrated after the surgery
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02388906). 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.