Phase 3
N=1,844
An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT03068455 ↗Enrolled (actual)
1,844
Serious AEs
33.6%
Results posted
Jul 2021
Primary outcome: Primary: Recurrence-free Survival (RFS) - All Randomized Participants — NA; NA Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- nivolumab (Biological); ipilimumab (Biological)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence-free Survival (RFS) - All Randomized Participants |
NA; NA | — |
| PRIMARY Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1% |
33.15; 27.63 | — |
| SECONDARY Overall Survival (OS) - All Randomized Participants |
NA; NA | — |
| SECONDARY Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1% |
NA; NA | — |
| SECONDARY Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression |
33.18; 25.33; NA; NA; NA; NA | — |
| SECONDARY Time to Next-Line Therapies - All Randomized Participants |
NA; NA; NA; NA | — |
| SECONDARY Time to Next-Line Therapies - All Randomized Participants With PD-L1 Expression Level < 1% |
NA; NA; NA; NA | — |
| SECONDARY Time From Next Therapy to Second Next Therapy - All Randomized Participants |
4.60; 4.80 | — |
| SECONDARY Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1% |
4.44; 5.04 | — |
| SECONDARY Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants |
NA; NA | — |
| SECONDARY Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1% |
NA; NA | — |
Summary
The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study.
- Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
- No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)
Exclusion Criteria
- History of uveal melanoma
- Patients with active, known or suspected autoimmune disease
- Prior treatment with interferon (if complete < 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03068455). 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.