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

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06101134
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 6, 2023
Status verified
Mar 2026
Primary completion
Apr 10, 2025
Completion
Aug 31, 2027

Study Design

Enrollment
100 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Metastatic Melanoma
  • Experimental: Cohort 2: Resected Melanoma

Primary Outcome Measure

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 [ Time Frame: Cycle 4 Day 1 (each cycle consist of 4 weeks) ]

Locations (9)

FacilityCityStateZIP
Local Institution - 0007AnchorageAlaska99508-2974
Local Institution - 0013PhoenixArizona85054-4502
Local Institution - 0010San FranciscoCalifornia94115-3010
Local Institution - 0034AtlantaGeorgia30342
Local Institution - 0032EdgewoodKentucky41017
Local Institution - 0028AlbuquerqueNew Mexico87106
Local Institution - 0037EdmondsWashington98026-8032
Local Institution - 0036IssaquahWashington98026
Local Institution - 0030SeattleWashington98104

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Melanoma
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By research site
Local Institution - 0007· Anchorage, AKLocal Institution - 0013· Phoenix, AZLocal Institution - 0010· San Francisco, CALocal Institution - 0034· Atlanta, GALocal Institution - 0032· Edgewood, KYLocal Institution - 0028· Albuquerque, NM

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