A Study to Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Unresectable or Metastatic Melanoma Participants In India
Nivolumab + Relatlimab: Specified dose on specified days
Study summary
The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in unresectable or metastatic melanoma participants in India.
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
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.
Note: Participants with ECOG PS 2 are allowed if the performance status of 2 is attributable to disease burden (and not to significant comorbidity), and if the investigator and Medical Monitor agree the patient may benefit from treatment.
* 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 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.
Note: Participants may enroll with the following conditions:
i) type 1 diabetes mellitus; ii) hypothyroidism only requiring hormone replacement; iii) skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; iv) conditions not expected to recur in the absence of an external trigger are permitted to enroll.
\- 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.
Note: Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
* Participants must not have a history of myocarditis.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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