StudyFinder
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)
RECRUITING
18 years and over
Key
• Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
• Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
• Measurable disease per RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
• Adequate bone marrow, hepatic, and kidney function
• Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol Key
• Uveal, acral or mucosal melanoma.
• Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
• 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:
• Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
• Systemic immune suppression as described in the protocol. Other Comorbidities:
• Participants with a history of myocarditis.
• Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
• Active or untreated brain metastases or spinal cord compression as described in the protocol. Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
Inclusion Criteria:
• Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
• Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
• Measurable disease per RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
• Adequate bone marrow, hepatic, and kidney function
• 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:
• Uveal, acral or mucosal melanoma.
• Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
• 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:
• Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
• Systemic immune suppression as described in the protocol. Other Comorbidities:
• Participants with a history of myocarditis.
• Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
• Active or untreated brain metastases or spinal cord compression as described in the protocol. Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
DRUG: fianlimab, DRUG: cemiplimab, DRUG: relatlimab+nivolumab
Melanoma
Unresectable Melanoma, Metastatic Melanoma, Advanced Melanoma, Stage III, Stage IV
Clinical Trials Administrator - clinicaltrials@regeneron.com
PHASE3
NCT06246916