Overview

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