A Study to Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Unresectable or Metastatic Melanoma Participants In India

Bristol-Myers Squibb (BMS)

Status and phase

Begins enrollment in 1 month

Phase 4

Conditions

Metastatic Melanoma

Unresectable Melanoma

Treatments

Drug: Nivolumab + Relatlimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT07459543

CA224-1125

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.