Melanoma
Conditions
Keywords
Unresectable Melanoma, Metastatic Melanoma, Advanced Melanoma, Stage III, Stage IV
Brief summary
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)
Interventions
DRUGfianlimab
Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab
DRUGcemiplimab
IV administration Q3W in combination with fianlimab
IV administration every 4 weeks (Q4W)
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR) | Up to 72 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) RECIST version 1.1 based on BICR | Up to 72 months | — |
| Death from any cause | Up to 72 months | — |
| Overall survival (OS) | Up to 72 months | — |
| Duration of Response (DOR) by BICR | Up to 72 months | — |
| DOR by investigator assessment | Up to 72 months | — |
| Disease control rate (DCR) by BICR | Up to 72 months | — |
| DCR by investigator assessment | Up to 72 months | — |
| ORR based on investigator assessment according to RECIST version 1.1 | Up to 72 months | — |
| PFS based on investigator assessment according to RECIST version 1.1 | Up to 72 months | — |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 72 months | — |
| Incidence of serious adverse events (SAEs) | Up to 72 months | — |
| Incidence of immune-mediated adverse events (imAEs) | Up to 72 months | — |
| Occurrence of interruption of study drug(s) due to AEs | Up to 72 months | — |
| Occurrence of discontinuation of study drug(s) due to AEs | Up to 72 months | — |
| TEAEs leading to death | Up to 72 months | — |
| Incidence of laboratory abnormalities | Up to 72 months | Grade ≥3 per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) including standard hematology, chemistry, urinalysis, and other lab tests |
| Concentration of fianlimab in serum | Up to 72 months | — |
| Concentration of cemiplimab in serum | Up to 72 months | — |
| Incidence of anti-drug antibodies (ADAs) to fianlimab | Up to 72 months | — |
| Titer of ADAs to fianlimab | Up to 72 months | — |
| Incidence of ADAs to cemiplimab | Up to 72 months | — |
| Titer of ADAs to cemiplimab | Up to 72 months | — |
| Incidence of neutralizing antibodies (NAbs) to fianlimab | Up to 72 months | — |
| Incidence of NAbs to cemiplimab | Up to 72 months | — |
Countries
Canada, United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed