Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
a study on Skin Cancer/Melanoma
The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS)
The secondary objectives of the study are:
- To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS)
- To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab
- To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component
- 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 fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years
A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
Melanoma, Unresectable, Metastatic, Stage III, Stage IV, Anti-Lymphocyte-activation gene 3 Pathway (LAG-3), Pembrolizumab, Cemiplimab, Fianlimab
You can join if…
Open to people ages 12 years and up
- Age ≥12 years on the date of providing informed consent
- Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease
- 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 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of >6 months.
- Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population.
- Measurable disease per RECIST v1.1
- Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
- Cutaneous lesions should be evaluated as non-target lesions
- Performance status:
- For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients ≤16 years)
- Anticipated life expectancy of at least 3 months
You CAN'T join if...
- 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.
- 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
- Unknown BRAF V600 mutation status as described in the protocol
- Systemic immune suppression:
- Use of immunosuppressive doses of corticosteroids (≤10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder.
- Other clinically relevant forms of systemic immune suppression
- Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy, major surgery or biological therapy within 21 days prior to the first dose of trial treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
- History or current evidence of significant (CTCAE Grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 14 days prior to the first dose of trial medication.
- Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they:
- Received radiotherapy or another appropriate standard therapy for the brain metastases,
- Have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment
- Did not require immunosuppressive doses of corticosteroids therapy (>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment
Are asymptomatic with a single untreated brain metastasis <10 mm in size
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
- University of California San Diego
accepting new patients
La Jolla California 92093 United States
- The Angeles Clinic and Research Institute
accepting new patients
Los Angeles California 90025 United States
- accepting new patients
- Start Date
- Completion Date
- Regeneron Pharmaceuticals
- Phase 3 Skin Cancer/Melanoma Research Study
- Study Type
- Expecting 1590 study participants
- Last Updated
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