A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)

Официальное название

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

Обзор

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)

Вмешательства

• Препарат fianlimab
  Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab
• Препарат cemiplimab
  IV administration Q3W in combination with fianlimab
• Препарат relatlimab+nivolumab
  IV administration every 4 weeks (Q4W)

Первичные конечные точки

• Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR) [Срок оценки: Up to 72 months]

Вторичные конечные точки (12)

• Progression free survival (PFS) RECIST version 1.1 based on BICR [Срок оценки: Up to 72 months]
• Death from any cause [Срок оценки: Up to 72 months]
• Overall survival (OS) [Срок оценки: Up to 72 months]
• Duration of Response (DOR) by BICR [Срок оценки: Up to 72 months]
• DOR by investigator assessment [Срок оценки: Up to 72 months]
• Disease control rate (DCR) by BICR [Срок оценки: Up to 72 months]
• DCR by investigator assessment [Срок оценки: Up to 72 months]
• ORR based on investigator assessment according to RECIST version 1.1 [Срок оценки: Up to 72 months]
• PFS based on investigator assessment according to RECIST version 1.1 [Срок оценки: Up to 72 months]
• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to 72 months]
• Incidence of serious adverse events (SAEs) [Срок оценки: Up to 72 months]
• Incidence of immune-mediated adverse events (imAEs) [Срок оценки: Up to 72 months]

Критерии участия

Критерии включения

• Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
• Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
• Measurable disease per RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
• Adequate bone marrow, hepatic, and kidney function
• Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol

Критерии исключения

Medical Conditions:

• Uveal, acral or mucosal melanoma.
• Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
• 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:

• Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
• Systemic immune suppression as described in the protocol.

Other Comorbidities:

• Participants with a history of myocarditis.
• Troponin T (TnT) or troponin I (TnI) >2x institutional upper limit of normal (ULN).
• Active or untreated brain metastases or spinal cord compression as described in the protocol.

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 104 центра

• Ironwood Cancer & Research Centers — Chandler
• Banner MD Anderson Cancer Center — Gilbert
• Arizona Oncology Associates — Tucson
• University of Arkansas for Medical Sciences — Little Rock
• Providence Medical Foundation — Fullerton
• Cancer and Blood Specialty Clinic — Los Alamitos
• University of California Los Angeles — Los Angeles
• St. Joseph Hospital Orange — Orange
• … и ещё 96 центров

Канада · 6 центров

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06246916 · R3767-ONC-22122

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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