Melanoma Clinical Trial
Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
Summary
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
Eligibility Criteria
Key Inclusion Criteria:
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
Key Exclusion Criteria:
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
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There are 119 Locations for this study
Miami Florida, 33176, United States
Morristown New Jersey, 07962, United States
Cleveland Ohio, 44106, United States
Adelaide , 05006, Australia
Geelong , 03220, Australia
Melbourne , 03004, Australia
Townsville , 04814, Australia
Innsbruck Tyrol, 6020, Austria
Graz , 8036, Austria
St. Poelten , 3100, Austria
Vienna , 01090, Austria
Brussels , 01200, Belgium
Kortrijk , 08500, Belgium
Namur , 05000, Belgium
Sint Niklaas , 09100, Belgium
Barretos , 14784, Brazil
Itajai , 88301, Brazil
Joinville , 89201, Brazil
Lages , 88501, Brazil
Lajeado , 95900, Brazil
Passo Fundo , 99010, Brazil
Porto Velho , 76834, Brazil
Sao Jose do Rio Preto , 15090, Brazil
Sao paulo , 01236, Brazil
Sao Paulo , 04014, Brazil
Barrie , L4M 6, Canada
Fredericton , E3B5N, Canada
Toronto , M5G 2, Canada
Recoleta Chi, 84200, Chile
Santiago Region Metropolitana De Santiago, 75100, Chile
Antofagasta , 12400, Chile
Santiago , 75609, Chile
Besancon Cedex , 25030, France
Bobigny , 93000, France
Bordeaux Cedex , 03307, France
Clermont-Ferrand , 63003, France
Dijon , 02100, France
Le Mans , 72037, France
Lille Cedex , 59037, France
Lyon cedex 08 , 69373, France
Nantes , 44000, France
Paris , 75005, France
Pierre Benite Cedex , 69495, France
Poitiers Cedex , 86021, France
Rouen , 76031, France
Saint-Etienne , 42055, France
Tbilisi , 0112, Georgia
Tbilisi , 0159, Georgia
Augsburg , 86179, Germany
Berlin , 10117, Germany
Buxtehude , 21614, Germany
Erfurt , 99089, Germany
Giessen , 35392, Germany
Göttingen , 37075, Germany
Luebeck , 23538, Germany
Mannheim , 68167, Germany
Muenster , 48157, Germany
Quedlinburg , 06484, Germany
Schwerin , 19055, Germany
Debrecen , 4032, Hungary
Nyíregyhaza , 04400, Hungary
Pecs , 7632, Hungary
Szeged , 06720, Hungary
Dublin 4 , D04 T, Ireland
Dublin , D08 N, Ireland
Brescia , 25123, Italy
Napoli , 80131, Italy
Novara , 28100, Italy
Pisa , 56126, Italy
Rome , 00167, Italy
San Giovanni Rotondo , 71013, Italy
Terni , 05100, Italy
Gdansk , 80-21, Poland
Siedlce , 08-11, Poland
Bucharest , 22328, Romania
Cluj-Napoca , 40001, Romania
Cluj , 40728, Romania
Craiova , 20034, Romania
Iasi , 70010, Romania
Iasi , 70038, Romania
Otopeni , 07510, Romania
Timisoara , 30021, Romania
Timisoara , 30023, Romania
Johannesburg , 02196, South Africa
Kraaifontein , 7570, South Africa
A Coruna , 15009, Spain
Barcelona , 08028, Spain
Barcelona , 08041, Spain
Cordoba , 14004, Spain
Girona , 17007, Spain
Lugo , 27003, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Malaga , 29011, Spain
Múrcia , 30120, Spain
Oviedo , 33011, Spain
San Sebastian , 20014, Spain
Sevilla , 41009, Spain
Valencia , 46009, Spain
Valencia , 46010, Spain
Ankara , 06520, Turkey
Ankara , 06680, Turkey
Edirne , 22000, Turkey
Istanbul , 34093, Turkey
Kocaeli , 41100, Turkey
Exeter Devon, EX2 5, United Kingdom
Guildford , GU2 7, United Kingdom
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