A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Genmab
- 入组人数
- 549
- 试验地点
- 546
- 主要终点
- Percentage of Participants Achieving Best Overall Response (BOR)
研究概览
简要总结
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.
Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0 to
- •Participant has:
- •Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
- •>= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.
- •Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.
- •Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)
- •Eligible to receive R2 per investigator determination.
- •Estimated Creatinine Clearance (CrCl) >= 50 mL/min.
排除标准
- •Documented refractoriness to lenalidomide.
- •Have lenalidomide exposure within 12 months prior to randomization.
研究组 & 干预措施
Epcoritamab Dose A in Combination With R2
Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
干预措施: Epcoritamab (Drug)
Epcoritamab Dose A in Combination With R2
Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
干预措施: Lenalidomide (Drug)
Epcoritamab Dose B in Combination With R2
Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.
干预措施: Epcoritamab (Drug)
Epcoritamab Dose A in Combination With R2
Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
干预措施: Rituximab (Drug)
Epcoritamab Dose B in Combination With R2
Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.
干预措施: Rituximab (Drug)
Epcoritamab Dose B in Combination With R2
Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.
干预措施: Lenalidomide (Drug)
Lenalidomide and Rituximab (R2)
Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
干预措施: Rituximab (Drug)
Lenalidomide and Rituximab (R2)
Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Percentage of Participants Achieving Best Overall Response (BOR)
时间窗: Up to approximately 5 years
BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria, as assessed by an IRC.
Progression-Free Survival (PFS)
时间窗: Up to approximately 5 years
PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first).
Percentage of Participants Achieving Best Overall Response (BOR)
时间窗: Up to approximately 2 years and 3 months
BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria, as assessed by an IRC.
Progression-Free Survival (PFS)
时间窗: Up to approximately 2 years and 3 months
PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first).
次要结局
- Percentage of Participants Achieving CR(Up to approximately 5 years)
- Overall Survival (OS)(Up to approximately 8 years from randomization)
- Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity(Up to approximately 5 years)
- Change in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)(Up to approximately 8 years)
- PFS as Assessed by Investigator(Up to approximately 5 years)
- Percentage of Participants Achieving BOR as Assessed by Investigator(Up to approximately 5 years)
- Percentage of Participants Achieving CR as Assessed by Investigator(Up to approximately 5 years)
- Duration of Response (DOR)(Up to approximately 8 years)
- Duration of Complete Response (DOCR)(Up to approximately 8 years)
- Time to Progression (TTP)(Up to approximately 8 years)
- Time to Next Anti-Lymphoma Treatment (TTNLT)(Up to approximately 8 years)
- Percentage of Participants Achieving CR at the End of Treatment(Up to approximately 5 years)
- Time to Response (TTR)(Up to approximately 8 years)
- Time to Complete Response (TTCR)(Up to approximately 8 years)
- Event-Free Survival (EFS)(Up to approximately 8 years)
- Time to next anti-lymphoma treatment (TTNLT)(Up to approximately 8 years)
- Change in Patient's Global Impression of Severity (PGIS)(Up to approximately 8 years)
- Change in Patient's Global Impression of Change (PGIC)(Up to approximately 8 years)
- Change in EuroQol 5-Dimension Questionnaire, 5-level (EQ-5D-5L)(Up to approximately 8 years)