Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Israel / NCT05625399
Active, not recruiting Phase 3

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

NCT05625399 · tracked via the Priya Life Science Israel tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2023-03-06
Last updated
2026-08-26

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

Nivolumab + RelatlimabAll Nivolumab trials (279) →All Relatlimab trials (48) →rHuPH20 →

Nivolumab + Relatlimab: Specified dose on specified days

rHuPH20: Specified dose on specified days

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.

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 adolescents (≥ 12 to \< 18 years of age). * Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system. * Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). * Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and \< 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent). * Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition). Exclusion Criteria * Participants must not have ocular melanoma. * Participants must not have a history of myocarditis, regardless of etiology. * Participants must not have a condition requiring systemic treatment with either corticosteroids (\>10 milligrams \[mg\] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

  • Adjusted Time-Averaged Nivolumab Serum Concentration Over the First 28 Days (Cavgd28-Nivo) on Natural Logarithmic Scale — Pre-dose (Day 1 to Day 28)
    Blood samples were collected to assess serum concentration.
  • Adjusted Time-Averaged Relatlimab Serum Concentration Over the First 28 Days (Cavgd28-Rela) on Natural Logarithmic Scale — Pre-dose (Day 1 to Day 28)
    Blood samples were collected to assess serum concentration.
  • Adjusted Trough Nivolumab Serum Concentration at Steady-State (Cminss-Nivo) on Natural Logarithmic Scale — Pre-dose (Day 1 to Day 28)
    Blood samples were collected to assess serum concentration.
  • Adjusted Trough Relatlimab Serum Concentration at Steady-State (Cminss-Rela) on Natural Logarithmic Scale — Pre-dose (Day 1 to Day 28)
    Blood samples were collected to assess serum concentration.

Trial sites (149)

FacilityCityRegionStatus
Local Institution - 0125 Phoenix Arizona
Local Institution - 0189 Springdale Arkansas
Local Institution - 0098 Los Angeles California
Local Institution - 0093 Orange California
Local Institution - 0123 Stanford California
Local Institution - 0113 Englewood Colorado
Local Institution - 0114 Jacksonville Florida
Local Institution - 0146 Baltimore Maryland
Local Institution - 0071 Rochester Minnesota
Local Institution - 0013 Omaha Nebraska
Local Institution - 0169 Cleveland Ohio
Local Institution - 0139 Easton Pennsylvania
Local Institution - 0124 Philadelphia Pennsylvania
Local Institution - 0122 Murray Utah
Local Institution - 0115 Fairfax Virginia
Local Institution - 0050 Coffs Harbour New South Wales
Local Institution - 0175 Orange New South Wales
Local Institution - 0172 Port Macquarie New South Wales
Local Institution - 0118 Wagga Wagga New South Wales
Local Institution - 0184 Waratah New South Wales
Local Institution - 0033 Westmead New South Wales
Local Institution - 0055 Wollstonecraft New South Wales
Local Institution - 0090 Birtinya Queensland
Local Institution - 0008 Bendigo Victoria
Local Institution - 0059 Box Hill Victoria
Local Institution - 0154 Heidelberg Victoria
Local Institution - 0030 Melbourne Victoria
Local Institution - 0109 Traralgon Victoria
Local Institution - 0106 Nedlands Western Australia
Local Institution - 0161 Nedlands Western Australia
Local Institution - 0027 Graz Austria
Local Institution - 0029 Salzburg Austria
Local Institution - 0168 Sankt Pölten Austria
Local Institution - 0037 Vienna Austria
Local Institution - 0072 Brussels Belgium
Local Institution - 0078 Charleroi Belgium
Local Institution - 0016 Liège Belgium
Local Institution - 0177 Fortaleza Ceará
Local Institution - 0180 Vitória Espírito Santo
Local Institution - 0107 Belo Horizonte Minas Gerais

+ 109 more sites — see the full list on the official registry below.

More Bristol-Myers Squibb trials in Israel

An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis Active, not recruiting
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma Active, not recruiting
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) Recruiting
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease Recruiting
A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01) Recruiting

Other trials for the same condition

A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors Active, not recruiting
A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery Active, not recruiting
A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) Active, not recruiting
A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051) Recruiting
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors 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 NCT05625399 on ClinicalTrials.gov ↗ ← All trials in Israel