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Closed (no longer recruiting)Last updated: 31 January 2024

RELATIVITY-098: This phase III trial is assessing the effectiveness of an immunotherapy drug (nivolumab) alone, or combined with another immunotherapy drug (relatlimab), in people with stage III-IV melanoma that has been completely surgically removedA Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Relatlimab and Nivolumab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

Clinical summary

Summary

Eligible participants will be randomly assigned to one of two experimental arms. In Experimental Arm A, participants will receive a combined treatment of Relatlimab + Nivolumab. In Experimental Arm B, participants will receive Nivolumab alone.

Conditions

This trial is treating patients with melanoma.

Cancer

Skin Cancers Skin

Age

People18+

Phase

III

Trial Acronym

RELATIVITY-098

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Relatlimab and Nivolumab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma

Eligibility

Inclusion

  • Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
  • Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and < 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%
  • Complete resection must be performed within 90 days prior to randomization
  • All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
  • Tumor tissue must be provided for biomarker analyses

Exclusion

  • History of ocular melanoma
  • Untreated/unresected CNS metastases or leptomeningeal metastases
  • Active, known, or suspected autoimmune disease
  • Participants with serious or uncontrolled medical disorder
  • Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
  • History of myocarditis, regardless of etiology.

Other protocol-defined inclusion/exclusion criteria apply

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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