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MelanomaPhase 2NCT06190951

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 testing cemiplimab and Fixed Dose Combination (FDC) cemiplimab+fianlimab in people with Melanoma, run by Regeneron Pharmaceuticals at 104 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
cemiplimab and Fixed Dose Combination (FDC) cemiplimab+fianlimab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
151 participants
Where
104 sitesin 8 countries
Study dates
18 Sep 2024to 9 Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must be either stage III (IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) per American Joint Committee on Cancer (AJCC) 8th edition (Amin 2017) and have histologically confirmed cutaneous melanoma that is deemed completely surgically resectable in order to be eligible as described in the protocol.
  • Patients with stage III melanoma must have clinically detectable disease that is confirmed as malignant on the pathology report. The pathology report must be reviewed, signed and dated by the investigator; this process will be confirmed during the interactive voice response system (IVRS) process as described in the protocol.
  • Patients must be candidates for full resection with curative intent and must be able to be surgically rendered free of disease with negative margins on resected specimens at surgery. The treatment plan including date of surgery must be documented by the investigator prior to randomization.
  • All patients must undergo full disease staging through a complete physical examination and imaging studies within 4 weeks prior to randomization. Imaging must include a computer tomography (CT) scan of the chest, abdomen, pelvis (if the primary tumor is on the head/neck then include a CT scan of head/neck), and all known sites of previously resected disease (if applicable) and brain magnetic resonance imaging (MRI) (or brain CT with contrast allowed if MRI is contraindicated).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Who cannot join

  • Medical conditions:
  • Primary uveal melanoma
  • Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
  • Patients must not have received any prior systemic anti-cancer therapy for melanoma. Prior radiotherapy for melanoma is allowed if not given to a target lesion or, if given to a target lesion, there is pathological evidence of disease progression in the same lesion.
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to or results in chronic infection as described in the protocol.
  • Prior/concomitant therapy:
Show all 12Show fewer
  • Use of immunosuppressive doses of corticosteroids (≥10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication as described in the protocol.
  • Treatment with any anti-cancer therapy for malignancies other than melanoma, including immuno- therapy, chemotherapy, radiotherapy, or biological therapy in the 5 years prior to randomization as described in the protocol.
  • Other comorbidities:
  • Participants with a history of myocarditis.
  • History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.
  • Note: Other protocol-defined inclusion/ exclusion criteria apply

Trial locations and contacts

104 sites in 8 countries.

104 sites in 8 countries

United States28 sites

  • Emory Healthcare, Emory Clinic

    Atlanta, Georgia, 30322

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute Brookline Avenue

    Boston, Massachusetts, 02215

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Seidman Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University James Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • UT Southwestern/Simmons Comprehensive Cancer Center

    Dallas, Texas, 75235

  • Duke Cancer Institute, University Hospital

    Durham, North Carolina, 27710

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • UC San Diego

    La Jolla, California, 92093

  • Northwell Health Cancer Institute

    Lake Success, New York, 11042

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90089

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Yale University Cancer Center

    New Haven, Connecticut, 06510

  • Hoag Family Cancer Institute

    Newport Beach, California, 92663

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • California Pacific Medical Center Research Institute

    San Francisco, California, 94115

  • University of California San Francisco (UCSF)

    San Francisco, California, 94143

  • St John's Cancer Institute

    Santa Monica, California, 90404

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

Germany17 sites

  • Charite University Medicine

    Berlin, 10117

  • Muhlenkreiskliniken Minden, Ruhr University Bochum

    Bochum, North Rhine-Westphalia, 44791

  • Klinikum Bremen Ost

    Bremen, 28325

  • Elbekliniken Stade Buxtehude

    Buxtehude, Lower Saxony, 21614

  • University Hospital Dresden

    Dresden, Saxony, 01307

  • Helios Klinikum Erfurt

    Erfurt, Thuringia, D-99089

  • University Hospital Essen

    Essen, North Rhine-Westphalia, 45147

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79104

  • SRH Wald- Klinikum Gera GmbH

    Gera, Thuringia, 07548

  • University Hospital Giessen

    Giessen, Hesse, 35385

  • Universitatsklinikum Leipzig, AoR

    Leipzig, Saxony, 04103

  • Universitatsklinikum Schleswig Holstein Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538

  • Hautklinik

    Ludwigshafen am Rhein, Rhineland-Palatinate, D-67063

  • LMU Klinikum

    Munich, Bavaria, 80337

  • University Hospital of Regensburg

    Regensburg, Bavaria, 93053

  • Universitatsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Universitaetsklinikum Wuerzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

France16 sites

  • Chu De Bordeaux

    Bordeaux, Gironde, 33075

  • Hopital Ambroise Pare

    Boulogne, 92104

  • Centre Francois Baclesse

    Caen, Normandy, 14000

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Centre Georges Francois Leclerc

    Dijon, Bourgogne-Franche-Comté, 21000

  • CHU-Dijon

    Dijon, Burgundy, 21000

  • Centre Hospitalier Universitaire Grenoble Alpes

    La Tronche, Isere, 38700

  • Regional University Hospital of Lille 2208

    Lille, 59037

  • Hopital Timone

    Marseille, 13385

  • Nantes University Hospital

    Nantes, Pays de la Loire Region, 44093

  • Centre Hospitalier Universitaire De Nice Hopital De L Archet

    Nice, 06202

  • Saint Louis Hospital

    Paris, Île-de-France Region, 75010

  • Hospices Civils de Lyon

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Centre Hospitalier Universitaire De Poitiers

    Poitiers, New Aquitaine, 86000

  • CHRU de Tours

    Tours, Centre-Val de Loire, 37044

  • Gustave Roussy

    Villejuif, Île-de-France Region, 94800

Other trials in France

Spain13 sites

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Instituto Oncologico Dr Rosell

    Barcelona, Catalonia, 08028

  • Vall d'Hebron Hospital

    Barcelona, 08029

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Clinico Universitario Virgen De La Arrixaca

    El Palmar, Murcia, 30120

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia, 18015

  • Hospital Clinico Universitario San Cecilio

    Granada, 18016

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Virgen De La Victoria Malaga

    Málaga, Andalusia, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitari Son Espases

    Palma, Balearic Islands, 07120

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Australia11 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Eastern Health

    Box Hill, Victoria, 3128

  • The Townsville Hospital

    Douglas, Queensland, 4814

  • Hervey Bay Hospital

    Hervey Bay, Queensland, 4655

  • Icon Cancer Centre Hobart

    Hobart, Tasmania, 7000

  • Lismore Base Hospital

    Lismore, New South Wales, 2480

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3052

  • One Clinical Research at Hollywood Private Hospital

    Nedlands, Western Australia, 6009

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Melanoma Institute of Australia

    Wollstonecraft, New South Wales, 2065

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

Italy11 sites

  • Azienda Ospedaliera Santa Croce i Carle

    Cuneo, 12100

  • Azienda Ospedaliero-Universitaria Ferrara

    Ferrara, 44124

  • Fondazione IRCCS Istituto Nazionale dei Tumori.

    Milan, 20133

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Istituto Nazionale Tumori IRCCS Fondazione G Pascale

    Naples, 80131

  • Universita della Campania Luigi Vanvitelli

    Naples, 80131

  • Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology

    Novara, 28100

  • U.O. Oncologia Medica 2 Universitaria, Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Campus Bio-Medico di Roma

    Rome, 00128

  • Medical Oncology

    Taormina, 98039

  • Azienda Sanitaria Universitaria del Friuli Centrale

    Udine, 33100

Other trials in Italy

Austria4 sites

  • Medical University of Graz

    Graz, Styria, 8036

  • Medical University Innsbruck

    Innsbruck, Tyrol, 6020

  • University Hospital Saint Poelten

    Sankt Pölten, Lower Austria, 3100

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Canada4 sites

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0C1

  • CHU de Quebec - Universite Laval

    Québec, G1J 1Z4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase 2 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV 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 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.

Read more

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
Melanoma
Being tested
cemiplimab, Fixed Dose Combination (FDC) cemiplimab+fianlimab, Placebo
Keywords
Skin cancer, Fully resectable stage III melanoma, Fully resectable stage IV melanoma
Medical subject headings
Melanoma, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cemiplimabDrug

    Also called REGN2810, Libtayo

    Administered per the protocol

  • Fixed Dose Combination (FDC) cemiplimab+fianlimabDrug

    Also called REGN2810, Libtayo, REGN3767

    Or coadministration, depending on availability.

  • PlaceboDrug

    Administered per the protocol

Study groups in NCT06190951
Study groupRoleWhat they receive
Arm AActive comparatorAs described in the protocol
Receives: Drug: cemiplimab; Drug: Placebo
Arm BExperimentalAs described in the protocol
Receives: Drug: Fixed Dose Combination (FDC) cemiplimab+fianlimab
Arm CExperimentalAs described in the protocol
Receives: Drug: Fixed Dose Combination (FDC) cemiplimab+fianlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response (pCR) rate as assessed by Blinded Independent Pathological Review (BIPR)

    Measured: Up to 1 year

Secondary outcomes (25)

  1. pCR rate as assessed by local pathologic review

    Measured: Up to 1 year

  2. Event-Free Survival (EFS)

    Measured: Up to 4 years

  3. Distant metastasis-free survival (DMFS)

    Measured: Up to 4 years

  4. Overall survival (OS)

    Measured: Up to 4 years

  5. Major pathological response (MPR) as assessed by BIPR

    Measured: Up to 4 years

  6. MPR rate as assessed by local pathologic review

    Measured: Up to 4 years

  7. Objective Response Rate (ORR) assessed by investigator per RECIST 1.1 criteria

    Measured: Up to 4 years

  8. ORR assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 criteria

    Measured: Up to 4 years

  9. Relapse-free survival (RFS)

    Measured: Up to 4 years

  10. Occurrence of treatment-emergent adverse events (TEAEs)

    Measured: 90 days following last dose of study drug, approximately 4 years

  11. Occurrence of immune-mediated adverse events (imAEs)

    Measured: 90 days following last dose of study drug, approximately 4 years

  12. Occurrence of serious adverse events (SAEs)

    Measured: 90 days following last dose of study drug, approximately 4 years

  13. Occurrence of adverse events of special interest (AESIs)

    Measured: 90 days following last dose of study drug, approximately 4 years

  14. Occurrence of TEAEs resulting in death

    Measured: 90 days following last dose of study drug, approximately 4 years

  15. Occurrence of interruption or discontinuation of study drug(s) due to TEAE.

    Measured: 90 days following last dose of study drug, approximately 4 years

  16. Occurrence of cancellation of surgery due to TEAE or delay to surgery

    Measured: 90 days following last dose of study drug, approximately 4 years

  17. Occurrence of laboratory abnormalities

    Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)

    Measured: 90 days following last dose of study drug, approximately 4 years

  18. Concentrations of fianlimab in serum

    Measured: Up to 4 years

  19. Concentrations of cemiplimab in serum

    Measured: Up to 4 years

  20. Anti-drug antibodies (ADA) in serum to fianlimab

    Measured: Up to 4 years

  21. ADA in serum to cemiplimab

    Measured: Up to 4 years

  22. Change from baseline in disease-related symptoms per Functional Assessment of Cancer Therapy-Melanoma (FACT-M) subscale

    The FACT-M is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-M is scored on a 5-point Likert-scale: "Not at all", "A little bit", "Somewhat", "Quite a bit", and "Very much.". A Higher score represents higher Health Related Quality of Life (HRQoL).

    Measured: Up to 4 years

  23. Change from baseline in functioning per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QoL) C30 (EORTC QLQ-C30)

    EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.

    Measured: Up to 4 years

  24. Change from baseline in global health status/QoL per EORTC QLQ-C30

    Measured: Up to 4 years

  25. Change from baseline in overall health state per European Quality of Life Dimension 5 (EQ-5D-5L)

    The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start18 Sep 2024
  3. Primary completion2 Nov 2026 (estimated)
  4. Study completion9 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06190951
Sponsor's protocol ID
R3767-ONC-2208
Other IDs
2022-502825-17-00
Status last verified
Feb 2026
First submitted
9 Nov 2023
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cemiplimab and Fixed Dose Combination (FDC) cemiplimab+fianlimab in people with Melanoma, run by Regeneron Pharmaceuticals at 104 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Germany, France, Spain, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate as assessed by Blinded Independent Pathological Review (BIPR) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06190951.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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