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NCT06101134 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations
A Phase 2 study of Melanoma, sponsored by Bristol-Myers Squibb.
- Active
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT06101134: Active Phase 2 study of Melanoma, sponsored by Bristol-Myers Squibb.
NCT06101134 is a Phase 2 study of Melanoma that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 100 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06101134, a Phase 2 study of Melanoma, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG relatlimab+nivolumab
- DRUG nivolumab
- DRUG relatlimab+nivolumab+rHuPH20
- DRUG nivolumab+rHuPH20
Study Locations (20)
Other
- Local Institution - 0005 - Concepción
- Local Institution - 0023 - Holargos, Athens
- Local Institution - 0008 - Piraeus
- Local Institution - 0033 - Thessaloniki
Washington
- Local Institution - 0037 - Edmonds
- Local Institution - 0036 - Issaquah
- Local Institution - 0030 - Seattle
I
- Local Institution - 0014 - Athens
- Local Institution - 0029 - Marousi
Alaska
- Local Institution - 0007 - Anchorage
Arizona
- Local Institution - 0013 - Phoenix
California
- Local Institution - 0010 - San Francisco
Georgia
- Local Institution - 0034 - Atlanta
Kentucky
- Local Institution - 0032 - Edgewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-11-06 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 2 |
What the registry record for NCT06101134 still lists
NCT06101134 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 4 interventions - of which relatlimab+nivolumab is the first listed.
NCT06101134 names 20 study sites across 14 states, led by Other, Washington, I.
Frequently Asked Questions
What is clinical trial NCT06101134 about?
NCT06101134 is a clinical study titled "A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations". 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 safe...
What is the current status of trial NCT06101134?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2023-11-06. Estimated completion is 2027-08-31.
What conditions does trial NCT06101134 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT06101134?
The interventions under investigation include: relatlimab+nivolumab (DRUG), nivolumab (DRUG), relatlimab+nivolumab+rHuPH20 (DRUG), nivolumab+rHuPH20 (DRUG).
Who is sponsoring clinical trial NCT06101134?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06101134 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06101134's enrollment target sits among peer trials
100 109th of 266 higher than 155 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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