A Phase 3 Trial of Fianlimab (REGN3767, Anti-Lag-3)+ Cemiplimab versus Pembrolizumab in Patients with Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma.
A Phase 3 Trial of Fianlimab (REGN3767, Anti-Lag-3)+ Cemiplimab versus Pembrolizumab in Patients with Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma.
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Clinical Trial Information
Trial Contact: Frankos, Marie; Caldwell, Chloe M; Donaldson, Karin M; Rodriguez Saavedra, Carlis M
Trial Phone: 321.841.7303 ; (321)841.1107 ; 321.841.9821 ; 321.841.6764
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IRB No: W22.061.03
Protocol Abbrev: R3767-ONC-2011
Principal Investigator: Sajeve Samuel Thomas, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: R3767-ONC-2011
Treatment: Cemiplimab Fianlimab Pembrolizumab
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT05352672
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Objective
Primary Objective
• To demonstrate superiority of fianlimab + cemiplimab compared
to pembrolizumab, as measured by progression-free survival
(PFS).
Secondary Objectives
• To demonstrate superiority of fianlimab (REGN3767) +
cemiplimab compared to pembrolizumab, as measured by overall
survival (OS).
• To demonstrate superiority in ORR with fianlimab + cemiplimab
compared to pembrolizumab.
• To characterize the objective response rate (ORR), PFS, and OS
with fianlimab + cemiplimab compared to cemiplimab to inform
the contribution of each components.
• To assess immunogenicity of fianlimab and cemiplimab.
• To assess impact of fianlimab + cemiplimab on physical
functioning and role functioning and global health status/quality of
life, as compared to pembrolizumab in adults.
• To characterize safety and tolerability of treatment in patients 12 to
<18 years of age.
• To characterize ORR, PFS, and OS with treatment in patients 12 to
<18 years of age.
• To assess the safety and tolerability of fianlimab + cemiplimab
compared to pembrolizumab and to cemiplimab.
• To characterize pharmacokinetics (PK) of treatment using sparse
PK sampling in patients aged ≥12 years. -
Key Eligibility
Inclusion:
1. Age ≥12 years on the date of providing informed consent.
Note: Patients who are <18 years will be included in the
territories, where accepted, per local laws and regulations.
2. A patient must have a valid LAG-3 immunohistochemistry
(IHC) result, as determined by central testing, to be enrolled
into the study. Any LAG-3 level (0-100% expression) will be
allowed.
3. Patients with histologically confirmed unresectable Stage III
and Stage IV (metastatic) melanoma (AJCC, eighth revised
edition) who have not received prior systemic therapy for
advanced unresectable disease.
a. Patients who received adjuvant and/or neoadjuvant systemic
therapies are eligible if they did not have evidence of
progression or recurrence of disease and/or discontinued due
to occurrence of unmanageable irAEs ≥ grade 3 while on such
therapies. Also, patients must have had a treatment-free and
disease-free interval of >6 months.
b. Patients with acral and mucosal melanomas are eligible.
Accrual will be limited to approximately 10% of the total
population.
4. Measurable disease per RECIST v1.1
a. Previously irradiated lesions can only be counted as target
lesions if they have been demonstrated to progress and no
other target lesion is available
b. Cutaneous lesions should be evaluated as non-target lesions.
5. Performance status:
a) For adult patients: Eastern Cooperative Oncology Group
(ECOG) performance status (PS) 0 or 1
b) For pediatric patients: Karnofsky performance status ≥70
(patients ≥16 years) or Lansky performance status ≥70
(patients <16 years)
6. Anticipated life expectancy of at least 3 months.
