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ACTIVE NOT RECRUITING Phase 3

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

NCT05625399 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

Conditions Studied

Interventions

  • DRUG Nivolumab + Relatlimab
  • DRUG rHuPH20

Study Locations (20)

New South Wales

  • Local Institution - 0050 — Coffs Harbour
  • Local Institution - 0175 — Orange
  • Local Institution - 0172 — Port Macquarie
  • Local Institution - 0118 — Wagga Wagga
  • Local Institution - 0184 — Waratah

California

  • Local Institution - 0098 — Los Angeles
  • Local Institution - 0093 — Orange
  • Local Institution - 0123 — Stanford

Pennsylvania

  • Local Institution - 0139 — Easton
  • Local Institution - 0124 — Philadelphia

Arizona

  • Local Institution - 0125 — Phoenix

Arkansas

  • Local Institution - 0189 — Springdale

Colorado

  • Local Institution - 0113 — Englewood

Florida

  • Local Institution - 0114 — Jacksonville

Maryland

  • Local Institution - 0146 — Baltimore

Trial Details

FieldValue
Enrollment Target 579 participants
Start Date 2023-03-06
Est. Completion 2027-11-18
Phase Phase 3

Sponsor

Bristol-Myers Squibb

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05625399

The ClinicalTrials.gov registry entry for NCT05625399 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 579 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions — of which Nivolumab + Relatlimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05625399 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New South Wales, California, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05625399 about?

NCT05625399 is a clinical study titled "A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma". The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

What is the current status of trial NCT05625399?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 579 participants. The study started on 2023-03-06. Estimated completion is 2027-11-18.

What conditions does trial NCT05625399 study?

This clinical trial studies the following conditions: Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05625399?

The interventions under investigation include: Nivolumab + Relatlimab (DRUG), rHuPH20 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05625399?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05625399 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial