A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

NCT06101134 · tracked via the Priya Life Science Spain tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 2

Started

2023-11-06

Last updated

2026-09-14

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

relatlimab+nivolumabAll Relatlimab trials (44) →All Nivolumab trials (276) →relatlimab+nivolumab+rHuPH20All Relatlimab trials (44) →All Nivolumab trials (276) →All Phesgo trials (15) →nivolumab →nivolumab+rHuPH20All Nivolumab trials (276) →All Phesgo trials (15) →

relatlimab+nivolumab: Specified dose on specified days

relatlimab+nivolumab+rHuPH20: Specified dose on specified days

nivolumab: Specified dose on specified days

nivolumab+rHuPH20: Specified dose on specified days

Study summary

The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease * Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma Exclusion Criteria: * Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs) Other protocol-defined inclusion/exclusion criteria apply.

Primary outcome measure(s)

Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose — Cycle 4 Day 1 (each cycle consist of 4 weeks)
PEPQ included 7 items 1. Pain or Discomfort (rated on 1 to 10 scale), 2. Length of time related to administration 3. Length of time related to administration impact amount of time to speak to doctor or nurse about illness or concern 4. Length of time for administration impact time to interact or socialize with other individuals 5. Convenience 6. Satisfaction 7. Choice of which route of administration would be preferred. 95% CI exact confidence interval was reported.

Trial sites (31)

Facility	City	Region
Local Institution - 0007	Anchorage	Alaska
Local Institution - 0013	Phoenix	Arizona
Local Institution - 0010	San Francisco	California
Local Institution - 0034	Atlanta	Georgia
Local Institution - 0032	Edgewood	Kentucky
Local Institution - 0028	Albuquerque	New Mexico
Local Institution - 0037	Edmonds	Washington
Local Institution - 0036	Issaquah	Washington
Local Institution - 0030	Seattle	Washington
Local Institution - 0015	Las Condes	Santiago Metropolitan
Local Institution - 0005	Concepción	Chile
Local Institution - 0019	Thessaloniki	B
Local Institution - 0014	Athens	I
Local Institution - 0029	Marousi	I
Local Institution - 0023	Holargos, Athens	Greece
Local Institution - 0008	Piraeus	Greece
Local Institution - 0033	Thessaloniki	Greece
Local Institution - 0017	Bergamo	BG
Local Institution - 0035	Meldola	FC
Local Institution - 0018	Milan	MI
Local Institution - 0012	Padova	PD
Local Institution - 0021	Roma	RM
Local Institution - 0004	Torino	TO
Local Institution - 0026	Naples	Italy
Local Institution - 0011	Barcelona	B
Local Institution - 0022	Barcelona	B
Local Institution - 0009	Cartagena	MU
Local Institution - 0020	Badalona	Spain
Local Institution - 0027	Cantabria	Spain
Local Institution - 0003	San Pedro Alcántara, Málaga	Spain
Local Institution - 0006	Seville	Spain

On this site

📄 Opdivo (nivolumab) drug profile →

More Bristol-Myers Squibb trials in Spain

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 to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome Active, not recruiting

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs Active, not recruiting

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis Active, not recruiting

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma Active, not recruiting

Other trials for the same condition

A Phase 1b Trial to Evaluate Safety of MB097 in Combination With Pembrolizumab in Melanoma Patients Active, not recruiting

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. Active, not recruiting

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma Active, not recruiting

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma Active, not recruiting

Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716) 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 NCT06101134 on ClinicalTrials.gov ↗ ← All trials in Spain