A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
- Conditions
- Melanoma
- Registration Number
- 2022-502825-17-00
- Lead Sponsor
- Regeneron Pharmaceuticals Inc.
- Brief Summary
Phase 2: To compare the treatment effect of the combination of fianlimab and cemiplimab to cemiplimab alone as peri-operative therapy in patients with resectable melanoma, as measured by pathological complete response (pCR) rate assessed by local pathological review, in order to inform (along with the totality of data from other fianlimab studies) the dose of fianlimab to use in combination with cemiplimab for the Phase 3 part of the study.
Phase 3: To assess the Event-free survival (EFS) for the combination of fianlimab and cemiplimab vs pembrolizumab alone as peri-operative therapy in patients with resectable melanoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Not specified
- Target Recruitment
- 254
All patients must be either stage III (IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) per American Joint Committee on Cancer (AJCC) 8th edition (Amin 2017) and have histologically confirmed cutaneous melanoma that is deemed completely surgically resectable in order to be eligible as described in the protocol.
Patients with stage III melanoma must have clinically detectable disease that is confirmed as malignant on the pathology report. The pathology report must be reviewed, signed and dated by the investigator; this process will be confirmed during the interactive voice response system (IVRS) process as described in the protocol.
Patients must be candidates for full resection with curative intent and must be able to be surgically rendered free of disease with negative margins on resected specimens at surgery. The treatment plan including date of surgery must be documented by the investigator prior to randomization.
All patients must undergo full disease staging through a complete physical examination and imaging studies within 4 weeks prior to randomization. Imaging must include a computer tomography (CT) scan of the chest, abdomen, pelvis (if the primary tumor is on the head/neck then include a CT scan of head/neck), and all known sites of previously resected disease (if applicable) and brain magnetic resonance imaging (MRI) (or brain CT with contrast allowed if MRI is contraindicated).
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Note: Other protocol-defined inclusion criteria apply
Primary uveal melanoma
Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
Patients must not have received any prior systemic anti-cancer therapy for melanoma. Prior radiotherapy for melanoma is allowed if not given to a target lesion or, if given to a target lesion, there is pathological evidence of disease progression in the same lesion.
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 as described in the protocol.
Use of immunosuppressive doses of corticosteroids (>=10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication as described in the protocol.
Treatment with any anti-cancer therapy for malignancies other than melanoma, including immuno- therapy, chemotherapy, radiotherapy, or biological therapy in the 5 years prior to randomization as described in the protocol.
Participants with a history of myocarditis.
History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.
Note: Other protocol-defined exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Phase 2: pCR rate as assessed by local pathological review Phase 2: pCR rate as assessed by local pathological review
Phase 3: EFS Phase 3: EFS
- Secondary Outcome Measures
Name Time Method Phase 2 and phase 3: pCR rate as assessed by BIPR Phase 2 and phase 3: pCR rate as assessed by BIPR
Phase 3: pCR rate as assessed by local pathological review Phase 3: pCR rate as assessed by local pathological review
Phase 2: EFS Phase 2: EFS
Phase 2 and phase 3: DMFS Phase 2 and phase 3: DMFS
Phase 2 and phase 3: OS Phase 2 and phase 3: OS
Phase 2 and phase 3: MPR as assessed by BIPR Phase 2 and phase 3: MPR as assessed by BIPR
Phase 2 and phase 3: MPR rate as assessed by local pathological review Phase 2 and phase 3: MPR rate as assessed by local pathological review
Phase 2 and phase 3: ORR assessed by investigator per RECIST 1.1 criteria Phase 2 and phase 3: ORR assessed by investigator per RECIST 1.1 criteria
Phase 2 and phase 3: ORR assessed by BICR per RECIST 1.1 criteria Phase 2 and phase 3: ORR assessed by BICR per RECIST 1.1 criteria
Phase 2 and phase 3: RFS Phase 2 and phase 3: RFS
Phase 2 and phase 3: Occurrence of treatment-emergent adverse events (TEAEs) Phase 2 and phase 3: Occurrence of treatment-emergent adverse events (TEAEs)
Phase 2 and phase 3: Occurrence of immune-mediated adverse events (imAEs) Phase 2 and phase 3: Occurrence of immune-mediated adverse events (imAEs)
Phase 2 and phase 3: Occurrence of serious adverse events (SAEs) Phase 2 and phase 3: Occurrence of serious adverse events (SAEs)
Phase 2 and phase 3: Occurrence of adverse events of special interest (AESIs) Phase 2 and phase 3: Occurrence of adverse events of special interest (AESIs)
Phase 2 and phase 3: Occurrence of TEAEs resulting in death Phase 2 and phase 3: Occurrence of TEAEs resulting in death
Phase 2 and phase 3: Occurrence of interruption or discontinuation of study drug(s) due to TEAE. Phase 2 and phase 3: Occurrence of interruption or discontinuation of study drug(s) due to TEAE.
Phase 2 and phase 3: Occurrence of cancellation of surgery due to TEAE or delay to surgery Phase 2 and phase 3: Occurrence of cancellation of surgery due to TEAE or delay to surgery
Phase 2 and phase 3: Occurrence of laboratory abnormalities Phase 2 and phase 3: Occurrence of laboratory abnormalities
Phase 2 and phase 3: Concentrations of fianlimab in serum Phase 2 and phase 3: Concentrations of fianlimab in serum
Phase 2 and phase 3: Concentrations of cemiplimab in serum Phase 2 and phase 3: Concentrations of cemiplimab in serum
Phase 2 and phase 3: Anti-drug antibodies (ADA) in serum to fianlimab Phase 2 and phase 3: Anti-drug antibodies (ADA) in serum to fianlimab
Phase 2 and phase 3: ADA in serum to cemiplimab Phase 2 and phase 3: ADA in serum to cemiplimab
Phase 2 and phase 3: Change from baseline in disease-related symptoms per FACT-M subscale Phase 2 and phase 3: Change from baseline in disease-related symptoms per FACT-M subscale
Phase 2 and phase 3: Change from baseline in functioning per EORTC QLQ-C30 Phase 2 and phase 3: Change from baseline in functioning per EORTC QLQ-C30
Phase 2 and phase 3: Change from baseline in global health status/QoL per EORTC QLQ-C30 Phase 2 and phase 3: Change from baseline in global health status/QoL per EORTC QLQ-C30
Phase 2 and phase 3: Change from baseline in overall health state per EQ-5D-5L Phase 2 and phase 3: Change from baseline in overall health state per EQ-5D-5L
Trial Locations
- Locations (54)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute Brookline Avenue
🇺🇸Boston, Massachusetts, United States
UC San Diego
🇺🇸La Jolla, California, United States
Usc Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Hoag Family Cancer Institute
🇺🇸Newport Beach, California, United States
California Pacific Medical Center Research Institute
🇺🇸San Francisco, California, United States
University of California San Francisco (UCSF)
🇺🇸San Francisco, California, United States
St John's Cancer Institute
🇺🇸Santa Monica, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Emory Healthcare, Emory Clinic
🇺🇸Atlanta, Georgia, United States
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