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

Launched by REGENERON PHARMACEUTICALS · Jan 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new combination of medications to treat advanced melanoma, a serious type of skin cancer. The trial is looking at an experimental drug called fianlimab combined with another medication called cemiplimab. Researchers want to find out how safe and effective this combination is compared to another approved treatment called Opdualag™, which combines two different drugs. Additionally, the study will look at potential side effects, how the body responds to the drugs over time, and whether the body creates antibodies that could affect the treatment.

To participate in the trial, individuals must be adults with a confirmed diagnosis of advanced melanoma that cannot be removed with surgery. They should not have received other treatments for their melanoma before joining the study and must meet certain health criteria, such as having good blood and organ function. Participants can expect to receive the study medications and will be monitored closely for their health and any side effects. This trial is currently recruiting participants, so if you or someone you know is interested and meets the eligibility criteria, this could be an option to consider.

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Eligibility 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
• • 6. Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol
• 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.
• Prior/Concomitant Therapy:
• • 4. Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
• • 5. Systemic immune suppression as described in the protocol.
• Other Comorbidities:
• • 6. Participants with a history of myocarditis.
• • 7. Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
• • 8. Active or untreated brain metastases or spinal cord compression as described in the protocol.
• • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.