A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab versus Relatlimab and Nivolumab in Participants with Unresectable or Metastatic Melanoma.
Primary:
To demonstrate superiority of Arm A (fianlimab + cemiplimab) compared to Arm B (Opdualag) as measured by objective response rate (ORR).
Secondary:
- To describe the duration of response (DOR) in Arm A and Arm B.
- To describe the disease control rate (DCR) in Arm A and Arm B
- To describe ORR and PFS by investigator assessment in Arm A and Arm B
- To assess the safety and tolerability of Arm A and Arm B
- To characterize the pharmacokinetics (PK) of fianlimab and cemiplimab in Arm A
- To assess the immunogenicity of fianlimab and cemiplimab
Fianlimab (REGN3767)
Opdivo (Nivolumab)
Relatlimab
- RWJBarnabas Health
- Community Medical Center
- Monmouth Medical Center
- Rutgers University
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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