Description:
The purpose of this study is to determine the effectiveness of nivolumab adjuvant
immunotherapy compared to placebo in adults and pediatric participants after complete
resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for
recurrence.
Title
- Brief Title: Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
- Official Title: A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
Clinical Trial IDs
- ORG STUDY ID:
CA209-76K
- SECONDARY ID:
2019-001230-34
- SECONDARY ID:
U1111-1229-8927
- NCT ID:
NCT04099251
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo | Nivolumab |
Purpose
The purpose of this study is to determine the effectiveness of nivolumab adjuvant
immunotherapy compared to placebo in adults and pediatric participants after complete
resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for
recurrence.
Trial Arms
Name | Type | Description | Interventions |
---|
Nivolumab | Experimental | | |
Placebo | Placebo Comparator | | |
Eligibility Criteria
Inclusion Criteria:
- Had a negative sentinel lymph node biopsy
- Participant has not been previously treated for melanoma
- ECOG 0 or 1
- Participants must have been diagnosed with histologically confirmed, Resected, Stage
IIB/C cutaneous melanoma
Exclusion Criteria:
- History of ocular or mucosal melanoma.
- Pregnant or nursing women
- Participants with active known or suspected autoimmune disease
- Known history of allergy or hypersensitivity to study drug components
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4
antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint
pathways
Other protocol defined inclusion/exclusion criteria could apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 12 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Recurrence-Free Survival (RFS) |
Time Frame: | Approximately 68 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall survival (OS) |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Occurrence of Adverse Events (AEs) as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Severity of AEs as defined by NCI CTCAE v5 |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Distant Metastases-Free Survival (DMFS) |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Investigator-assessed outcomes on next-line therapies [Objective response rates (if applicable), Duration of treatment on next-line therapies, Progression-Free Survival 2, End-of-next-line-treatment] |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
July 26, 2021