A Phase 2/3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 960
- 试验地点
- 25
研究概览
简要总结
Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy.
The goals of this study are to learn:
- About the safety of MK-1045 and rituximab, and if people tolerate them when given together
- If people who receive MK-1045 and rituximab have the cancer go away
- If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)
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
- Single (Outcomes Assessor)
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
- •Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-
- •Has radiographically measurable disease per the Lugano Response Criteria.
- •Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.
- •If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).
- •If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.
- •If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
排除标准
- •Has received prior systemic anticancer therapy or radiotherapy for FL.
- •Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.
- •Has FL that has transformed into a more aggressive type of lymphoma.
- •History or presence of clinically relevant central nervous system (CNS) diseases.
- •Has history of serious cardiovascular and cerebrovascular diseases.
- •Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- •Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- •Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Has known active CNS lymphoma or involvement.
- •Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- •Has active infection requiring systemic therapy.
- •Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.
- •Has not adequately recovered from major surgery or has ongoing surgical complications.
研究组 & 干预措施
Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)
Participants will receive physician's choice of: 90 mg/m^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 1.4 mg/m^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m^2 cyclophosphamide and 1.4 mg/m^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.
干预措施: Vincristine (Drug)
Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)
Participants will receive physician's choice of: 90 mg/m^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 1.4 mg/m^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m^2 cyclophosphamide and 1.4 mg/m^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.
干预措施: Rituximab (Biological)
Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)
Participants will receive physician's choice of: 90 mg/m^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 1.4 mg/m^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m^2 cyclophosphamide and 1.4 mg/m^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.
干预措施: Rituximab biosimilar (Biological)
Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)
Participants will receive physician's choice of: 90 mg/m^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 1.4 mg/m^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m^2 cyclophosphamide and 1.4 mg/m^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.
干预措施: Bendamustine (Drug)
Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)
Participants will receive physician's choice of: 90 mg/m^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 1.4 mg/m^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m^2 cyclophosphamide and 1.4 mg/m^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.
干预措施: Cyclophosphamide (Drug)
Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)
Participants will receive physician's choice of: 90 mg/m^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 1.4 mg/m^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m^2 cyclophosphamide and 1.4 mg/m^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.
干预措施: Prednisone (Drug)
Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)
Participants will receive physician's choice of: 90 mg/m^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 1.4 mg/m^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m^2 cyclophosphamide and 1.4 mg/m^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.
干预措施: Prednisolone (Drug)
Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)
Participants will receive physician's choice of: 90 mg/m^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 1.4 mg/m^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m^2 cyclophosphamide and 1.4 mg/m^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.
干预措施: Doxorubicin Hydrochloride (Drug)
Part 1: MK-1045 plus Rituximab (or biosimilar)
Participants will receive escalating doses of MK-1045 (from 2 mg to 90 mg) once weekly (QW) for up to approximately 12 months. Participants will also receive 375 mg/m^2 rituximab (or biosimilar) once every 4 weeks (Q4W) for up to approximately 6 months.
干预措施: MK-1045 (Biological)
Part 1: MK-1045 plus Rituximab (or biosimilar)
Participants will receive escalating doses of MK-1045 (from 2 mg to 90 mg) once weekly (QW) for up to approximately 12 months. Participants will also receive 375 mg/m^2 rituximab (or biosimilar) once every 4 weeks (Q4W) for up to approximately 6 months.
干预措施: Rituximab (Biological)
Part 1: MK-1045 plus Rituximab (or biosimilar)
Participants will receive escalating doses of MK-1045 (from 2 mg to 90 mg) once weekly (QW) for up to approximately 12 months. Participants will also receive 375 mg/m^2 rituximab (or biosimilar) once every 4 weeks (Q4W) for up to approximately 6 months.
干预措施: Rituximab biosimilar (Biological)
Part 2: MK-1045 plus Rituximab (or biosimilar)
Participants will receive MK-1045 QW at the dose determined in Part 1 for up to approximately 12 months. Participants will also receive 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months.
干预措施: Rituximab biosimilar (Biological)
Part 2: MK-1045 plus Rituximab (or biosimilar)
Participants will receive MK-1045 QW at the dose determined in Part 1 for up to approximately 12 months. Participants will also receive 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months.
干预措施: Rituximab (Biological)
Part 2: MK-1045 plus Rituximab (or biosimilar)
Participants will receive MK-1045 QW at the dose determined in Part 1 for up to approximately 12 months. Participants will also receive 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months.
干预措施: MK-1045 (Biological)