A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma

Plain English Summary

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma is a Phase 3 clinical trial sponsored by Bristol-Myers Squibb studying Melanoma. This study tests if nivolumab, an immunotherapy drug, can prevent melanoma from returning after surgery, compared to a placebo (a dummy treatment). It is for adults and children who have had Stage IIB/C melanoma completely removed and are at high risk of the cancer coming back. Participants will receive either nivolumab or a placebo through an IV, and will be monitored for side effects and cancer recurrence. Standard treatment after surgery for this stage of melanoma may involve observation or other therapies, depending on individual risk factors. The trial aims to enroll 790 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are an adult or child diagnosed with Stage IIB/C melanoma that has been surgically removed, and you haven't had prior melanoma treatment. You must have had a negative sentinel lymph node biopsy and be in good general health (ECOG 0 or 1). You cannot join if you have a history of eye or mucosal melanoma, are pregnant or breastfeeding, have autoimmune diseases, or have had certain prior cancer treatments. This trial is studying Melanoma, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome, Recurrence Free Survival, measures how long patients live without their melanoma returning or developing a new one, or dying from any cause. The specific primary outcome measures are: Recurrence Free Survival (RFS) (From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need to prevent melanoma from returning in high-risk patients after surgery, a significant unmet need in melanoma treatment. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Melanoma, where improved treatment options are needed.

Investor Insight

This trial is significant as it evaluates a key immunotherapy drug in the adjuvant setting for melanoma, a large market with ongoing competition to improve cure rates post-surgery. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 790 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of nivolumab compared to placebo, and what participation involves. Participation includes regular clinic visits for drug infusions, blood tests, and scans to monitor your health and cancer status. You will receive either the study drug or a placebo for a set period, and will be followed for several years to track outcomes. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 790 participants

Interventions

• BIOLOGICAL: Nivolumab — Specified dose on specified days
• OTHER: Placebo — Specified dose on specified days

Primary Outcomes

• Recurrence Free Survival (RFS) (From randomization up to the date of first recurrence, new primary melanoma, or death (whatever the cause), whichever occurs first (up to 32 months))

Secondary Outcomes

• Distant Metastasis-Free Survival (DMFS) (From randomization up to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first (up to approximately 32 months))
• Duration of Treatment on Next Line Therapy Per Investigator Assessment (From first dose date of next-line therapy to last dose date of next-line therapy (up to approximately 32 months))
• Progression-Free Survival Through Next-Line Therapy (From randomization to recurrence/objective disease progression after the start of the next-line therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first (up to approximately 32 months))
• Number of Participants Experiencing Adverse Events (AEs) (From first dose up to 30 days post last dose of the blinded phase (up to 13 months))
• Number of Participants Experiencing Adverse Events Leading to Discontinuation (From first dose up to 30 days post last dose of the blinded phase (up to 13 months))

Full 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 apply.

Trial Locations

• Local Institution - 0088, Birmingham, Alabama, United States
• Local Institution - 0126, Tucson, Arizona, United States
• Local Institution - 0087, Springdale, Arkansas, United States
• Local Institution - 0080, Los Angeles, California, United States
• Local Institution - 0077, San Francisco, California, United States
• Local Institution - 0119, San Francisco, California, United States
• Local Institution - 0122, San Jose, California, United States
• Local Institution - 0121, Vallejo, California, United States
• Local Institution - 0109, Vallejo, California, United States
• Local Institution - 0120, Vallejo, California, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Melanoma
• Skin Cancer
• Oncology
• Immunotherapy
• Adjuvant Therapy
• Metastatic Melanoma
• Cutaneous Melanoma
• High-Risk Melanoma
• Cancer Recurrence
• Checkpoint Inhibitors

More Melanoma Trials

View all Melanoma clinical trials