Pure Global AI
NCT06101134Not yet recruiting

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

A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for Nivolumab + Relatlimab Fixed-dose Combination Subcutaneous Versus Nivolumab + Relatlimab Fixed-dose Combination Intravenous and Nivolumab Subcutaneous Versus Nivolumab Intravenous in Participants With Melanoma
Bristol-Myers SquibbPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Melanoma
Drug/Device/Intervention
relatlimab+nivolumab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Bristol-Myers Squibb
Location
Anchorage,Phoenix,San Francisco,Albuquerque,New York,Cipolletti,Viedma,Rosario,Las Condes,Concepcion,Las Condes,Thessaloniki,Athens,Marousi,Holargos, Athens,Peiraias,Bergamo,Milan,Padova,Roma,Torino,N, Argentina,Chile,Greece,Italy,Spain,United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Dec 29, 2023
End date
Aug 31, 2027
Enrollment
100 participants
Primary outcome

Number of participants that prefer subcutaneous (SC) route of administration as assessed by Question 7 of the Patient Experience and Preference Questionnaire (PEPQ)

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.

ICD-10 classifications
Malignant melanoma of skinMelanoma in situ, unspecifiedMelanoma in situMelanoma and other malignant neoplasms of skinMalignant neoplasm: Malignant melanoma of skin, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06101134
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06101134 through Pure Global AI's free database. This Phase 2 trial is sponsored by Bristol-Myers Squibb and is currently Not yet recruiting. The study focuses on Melanoma. Target enrollment is 100 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.