Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Melanoma, sponsored by Regeneron Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT06190951 still lists
NCT06190951 is an interventional study that assigns participants to a tested intervention. The registered 151 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 (79% lower).
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 names 20 study sites across 11 states, led by 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.
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 NCT06190951's enrollment target sits among peer trials
151 87th of 266 higher than 180 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
RECRUITING · Phase 2
-
Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
RECRUITING · Phase 2
-
Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma
RECRUITING · Phase 2
-
A Study of IBI363 in Subjects with Advanced Solid Malignancies
RECRUITING · Phase 2
-
A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab
RECRUITING · Phase 2
-
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01409161 · 151 participants · Phase 2
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
- NCT04245397 · 151 participants · Phase 1
Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome
- NCT05761223 · 151 participants · Phase 1
A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
- NCT07195656 · 151 participants · NA
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI