A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,564
- 试验地点
- 377
- 主要终点
- Relapse free survival (RSF)
研究概览
简要总结
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab.
The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting.
The study is looking at several other research questions, including:
- What side effects may happen from receiving the study drugs.
- How much study drug is in the blood at different times.
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections.
- How administering the study drugs might improve quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
- •Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
- •All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol
排除标准
- •Uveal melanoma
- •Any evidence of residual disease after surgery by imaging, pathology, or cytology.
- •Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment
- •Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
- •Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
- •Participants with a history of myocarditis
- •Adolescent patients (≥12 to <18 years old) with body weight <40 kg
- •Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
研究组 & 干预措施
Fianlimab LD + Cemiplimab
Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab
干预措施: Fianlimab (Drug)
Fianlimab HD + Cemiplimab
Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab
干预措施: Cemiplimab (Drug)
Fianlimab LD + Cemiplimab
Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab
干预措施: Cemiplimab (Drug)
Pembrolizumab
Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo
干预措施: Placebo (Drug)
Fianlimab HD + Cemiplimab
Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab
干预措施: Fianlimab (Drug)
Pembrolizumab
Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Relapse free survival (RSF)
时间窗: Up to 5 Years
Time from randomization to the first documented recurrence of disease at any site (excluding new primary melanomas) or death from any cause, whichever occurs first.
次要结局
- Overall survival (OS)(Up to 5 Years)
- Distant metastasis-free survival (DMFS)(Up to 5 Years)
- Occurrence of immune-mediated EAEs (im-EAEs)(Up to 5 Years)
- Occurrence of treatment-emergent adverse events (TEAEs)(Up to 5 Years)
- Occurrence of serious adverse events (SAEs)(Up to 5 Years)
- Occurrence of adverse events of special interest (AESIs)(Up to 5 Years)
- Occurrence of laboratory abnormalities(Up to 5 Years)
- Concentrations of fianlimab in serum over time(Up to 5 Years)
- Patient report outcomes (PRO) for adults as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)(Up to 5 Year)
- PRO for adults as measured by the European Quality of Life Dimension 5 (EQ-5D-5L)(Up to 5 Years)
- PRO for adults as determined by the Patient Global Impressions Scale (PGIS)(Up to 5 Years)
- Time to physical functioning deterioration per EORTC QLQ-C30(Up to 5 Years)
- Occurrence of TEAEs resulting in death(Up to 5 Years)
- Occurrence of dose-limiting toxicity (DLT)(Up to 5 Years)
- Occurrence of interruption or discontinuation of study drug(s) due to TEAE(Up to 5 Years)
- Time to global health status/quality of life deterioration per EORTC QLQ-C30(Up to 5 years)
- Concentrations of cemiplimab in serum over time(Up to 5 Years)
- Concentration of finalimab anti-drug antibodies (ADA) and neutralizing antibodies(Up to 5 Years)
- Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies(Up to 5 Years)
- PRO for adults as determined by the Patient Global Impressions of Change Scale (PGIC)(Up to 5 Years)
- PRO for adults as measured by the Functional Assessment of Cancer Therapy (FACT) - melanoma(Up to 5 Years)
- Time to role functioning deterioration per EORTC QLQ-C30(Up to 5 Years)