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NCT06190951 · ClinicalTrials.gov registry record · Phase 2
A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
A Phase 2 study of Melanoma, sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 151
- Enrollment target
- 20
- Study locations
NCT06190951 is a Phase 2 study of Melanoma that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 151 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT06190951, a Phase 2 study of Melanoma, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 151 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with cemiplimab alone. These types of immunotherapy study drugs are collectively known as immune checkpoint inhibitors. Immunotherapies are treatments that use the immune system to recognize and kill cancer cells. The study is focused on participants with a type of skin cancer known as melanoma. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to cemiplimab in participants with high-risk, resectable melanoma. Participants will receive treatment before surgery, undergo resection, and then will have the option to continue treatment after resection. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug(s). * How much study drug(s) is in the blood at different times. * Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG cemiplimab
- DRUG Fixed Dose Combination (FDC) cemiplimab+fianlimab
Study Locations (20)
California
- UC San Diego - La Jolla
- USC Norris Comprehensive Cancer Center - Los Angeles
- Hoag Family Cancer Institute - Newport Beach
- California Pacific Medical Center Research Institute - San Francisco
- University of California San Francisco (UCSF) - San Francisco
- St John's Cancer Institute - Santa Monica
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute Brookline Avenue - Boston
- University of Massachusetts Chan Medical School - Worcester
Connecticut
- Hartford Hospital - Hartford
- Yale University Cancer Center - New Haven
Ohio
- Seidman Cancer Center - Cleveland
- Cleveland Clinic Foundation - Cleveland
Colorado
- University of Colorado Cancer Center - Aurora
Georgia
- Emory Healthcare, Emory Clinic - Atlanta
Illinois
- NorthShore University HealthSystem - Evanston
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2024-09-18 |
| Est. Completion | 2030-12-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06190951
The ClinicalTrials.gov registry entry for NCT06190951 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (79% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06190951 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Massachusetts, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06190951 about?
NCT06190951 is a clinical study titled "A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma". This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with cemiplimab alone. These types of immunotherapy study ...
What is the current status of trial NCT06190951?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 151 participants. The study started on 2024-09-18. Estimated completion is 2030-12-09.
What conditions does trial NCT06190951 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT06190951?
The interventions under investigation include: Placebo (DRUG), cemiplimab (DRUG), Fixed Dose Combination (FDC) cemiplimab+fianlimab (DRUG).
Who is sponsoring clinical trial NCT06190951?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06190951 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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