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Combining fianlimab and cemiplimab for treating advanced melanoma

A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Phase 3 Interventional Regeneron Pharmaceuticals · NCT05352672

This study is testing if a new combination of two drugs, fianlimab and cemiplimab, can help teenagers and adults with advanced melanoma feel better compared to a standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1535 (estimated)
Ages12 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionschemotherapy, prednisone, fianlimab, cemiplimab, pembrolizumab
Locations219 sites (La Jolla, California and 218 other locations)
Trial IDNCT05352672 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the effectiveness of an experimental drug, fianlimab, in combination with cemiplimab, compared to pembrolizumab in treating unresectable locally advanced or metastatic melanoma in adolescents and adults. The study aims to evaluate the safety, efficacy, and pharmacokinetics of these treatments, as well as the immune response generated against the drugs. Participants will be monitored for side effects and the presence of antibodies against the study drugs. The study includes patients aged 12 and older who have not received prior systemic therapy for their advanced melanoma.

Who should consider this trial

Good fit: Ideal candidates are adolescents and adults aged 12 and older with unresectable Stage III or IV melanoma who have not received prior systemic therapy.

Not a fit: Patients with resectable melanoma or those who have previously received systemic therapy for advanced disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced melanoma.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this combination treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Age ≥12 years on the date of providing informed consent
2. Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease

   1. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable imAEs ≥ grade 3 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of \>6 months. Accrual of these patients is limited to approximately 10% of the total population enrolled.
   2. Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population.
3. Measurable disease per RECIST v1.1

   1. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
   2. Cutaneous lesions should be evaluated as non-target lesions
4. Performance status:

   1. For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
   2. For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients ≤16 years)
5. Anticipated life expectancy of at least 3 months

Key Exclusion Criteria:

1. Uveal melanoma
2. 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.
3. 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
4. Unknown BRAF V600 mutation status as described in the protocol
5. Systemic immune suppression:

   1. Use of immunosuppressive doses of corticosteroids (\>10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder.
   2. Other clinically relevant forms of systemic immune suppression
6. Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy, major surgery or biological therapy within 21 days prior to the first dose of trial treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
7. History or current evidence of significant (CTCAE Grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 14 days prior to the first dose of trial medication.
8. Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they:

   1. Received radiotherapy or another appropriate standard therapy for the brain metastases,
   2. Have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment
   3. Did not require immunosuppressive doses of corticosteroids therapy (\>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment
   4. Are asymptomatic with a single untreated brain metastasis \<10 mm in size
9. Participants with a history of myocarditis.

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Where this trial is running

La Jolla, California and 218 other locations

+169 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MelanomaUnresectableMetastaticStage IIIStage IVAnti-Lymphocyte-activation gene 3 Pathway
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.