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Clinical Trials in Italy / NCT03470922
Active, not recruiting Phase 2/3

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

NCT03470922 · tracked via the Priya Life Science Italy tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 2/3
Started
2018-04-11
Last updated
2025-09-09

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

Relatlimab →Nivolumab →

Relatlimab: Specified dose on specified day

Nivolumab: Specified dose on specified days

Study summary

The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab monotherapy in treating unresectable melanoma or melanoma that has spread.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system * Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma * Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses 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 Other protocol defined inclusion/exclusion criteria could apply

Primary outcome measure(s)

  • Progression Free Survival (PFS) — From randomization to date of first documented tumor progression or death (up to approximately 33 months)
    Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.

Trial sites (127)

FacilityCityRegionStatus
Local Institution - 0010 Tucson Arizona
Local Institution - 0020 Los Angeles California
Coastal Integrative Cancer Care San Luis Obispo California
Local Institution - 0116 Santa Barbara California
Local Institution - 0012 Washington D.C. District of Columbia
Local Institution - 0013 Jacksonville Florida
Local Institution - 0117 Orlando Florida
Local Institution - 0007 Tampa Florida
Local Institution - 0038 Atlanta Georgia
Local Institution - 0016 Chicago Illinois
Local Institution - 0114 Fort Wayne Indiana
Local Institution - 0077 Baltimore Maryland
Local Institution - 0120 Baltimore Maryland
Local Institution - 0014 Boston Massachusetts
Local Institution - 0134 Boston Massachusetts
Local Institution - 0015 Ann Arbor Michigan
Local Institution - 0009 Minneapolis Minnesota
Local Institution - 0011 Rochester Minnesota
Local Institution - 0018 Charlotte North Carolina
Local Institution - 0019 Allentown Pennsylvania
Local Institution - 0076 Dallas Texas
Local Institution - 0008 Houston Texas
Local Institution - 0135 Buenos Aires Distrito Federal
Local Institution - 0002 Capital Federal Distrito Federal
Local Institution - 0004 Buenos Aires Argentina
Local Institution - 0003 Buenos Aires Argentina
Local Institution - 0005 Buenos Aires Argentina
Local Institution - 0042 North Sydney New South Wales
Local Institution - 0043 Waratah New South Wales
Local Institution - 0041 Greenslopes Queensland
Local Institution - 0045 Southport Queensland
Local Institution - 0133 Bedford Park South Australia
Local Institution - 0044 Murdoch Western Australia
Local Institution - 0036 Graz Styria
Local Institution - 0037 Salzburg Austria
Local Institution - 0035 Vienna Austria
Local Institution - 0047 Brussels Belgium
Local Institution - 0049 Brussels Belgium
Local Institution - 0048 Ghent Belgium
Local Institution - 0058 Belo Horizonte Minas Gerais

+ 87 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile →

More Bristol-Myers Squibb trials in Italy

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy Recruiting
A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5) Recruiting
A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease Recruiting
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02) Starting soon
A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis Recruiting

Other trials for the same condition

A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors Recruiting
A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations Active, not recruiting
A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer Active, not recruiting
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors Active, not recruiting
A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma Active, not recruiting
Official registry record

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.

View NCT03470922 on ClinicalTrials.gov ↗ ← All trials in Italy