A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection

• Status: Active, not recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of study is to compatibility the pharmacokinetic (PK) of Process D relative to Process C.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Nivolumab

Criteria

Inclusion Criteria:

• Late Stage melanoma that is completely surgically resected and pathologically absent

• Participants must not have received anti-cancer therapy greater than equal to (>=) 6 months prior to randomization

• Imaging studies to include Computed tomography (CT), Magnetic resonance imaging (MRI), positron emission tomography (PET) scans that show no clinically detectable nodes on imaging

Exclusion Criteria:

• Participants must not have a history of ocular/uveal melanoma

• Participants with active, known, or suspected autoimmune disease(s) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll

• Participants must not have prior malignancy active within the previous 3 years except for locally curable cancers

• Participants must not have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.

• Participants must not have had prior therapy for melanoma except surgery, for the melanoma lesion(s) adjuvant radiation therapy after neurosurgical resection for CNS lesions and except for participants who received prior adjuvant interferon therapy

• Treatment directed against the resected melanoma that is administered after complete resection other than adjuvant radiation