A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Melanoma

Treatments: Drug: fianlimab; Drug: cemiplimab; Drug: relatlimab+nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06246916

R3767-ONC-22122

Details and patient eligibility

About

This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children.

The study is looking at several other research questions, including:

• What side effects may happen from taking the study drugs.
• How much study drug is in the blood at different times.
• Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)

Enrollment: 560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
2. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
3. Measurable disease per RECIST version 1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
5. Adequate bone marrow, hepatic, and kidney function.

Key Exclusion Criteria:

Medical Conditions:

1. Uveal, acral or mucosal melanoma.

2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.

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. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed.

4. Unknown v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status as described in the protocol.

   Prior/Concomitant Therapy:

5. Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol

6. Systemic immune suppression as described in the protocol.

   Other Comorbidities:

7. Participants with a history of myocarditis.

8. Troponin T (TnT) or troponin I (TnI) >2x institutional upper limit of normal (ULN).

9. Active or untreated brain metastases or spinal cord compression as described in the protocol.

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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560 participants in 2 patient groups

fianlimab+cemiplimab

Experimental group

Description:

Randomized 1:1

Treatment:

Drug: cemiplimab

Drug: fianlimab

relatlimab+nivolumab

Active Comparator group

Description:

Randomized 1:1

Treatment:

Drug: relatlimab+nivolumab