Untreated Melanoma, Unresectable Melanoma, Metastatic Melanoma
Conditions
Keywords
Skin Cancer, Malignant Melanoma, Immunotherapy, India, Nivolumab, Relatlimab
Brief summary
The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in untreated, unresectable or metastatic melanoma participants in India
Interventions
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for minors (ages 12-17) ONLY. * Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) staging system (8th edition). * Participants must be treatment-naïve (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma). * Participants must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. * Participants must have completed prior radiotherapy at least 2 weeks prior to study treatment administration. * Individuals of Childbearing Potential (IOCBP) must not be pregnant or breastfeeding.
Exclusion criteria
* Participants must not have active brain metastases or leptomeningeal metastases. * Participants must not have uveal melanoma. * Participants must not have an active, known, or suspected autoimmune disease. * Participants must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. * Participants must not have a history of myocarditis. * Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways. Prior treatment with relatlimab or any other with LAG-3 targeted agents. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | Up to 30 weeks |
| Incidence of drug-related AEs | Up to 30 weeks |
| Incidence of serious adverse events (SAEs) | Up to 30 weeks |
| Incidence of drug-related SAEs | Up to 30 weeks |
| Incidence of immune-mediated adverse events (IMAEs) | Up to 30 weeks |
| AEs leading to discontinuation of treatment | Up to 30 weeks |
| Number of deaths | Up to 30 weeks |
| Number of participants with laboratory abnormalities | Up to 30 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) as assessed by investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 30 weeks |
Countries
India
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed