Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT04759586
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- Primary Mediastinal Large B-Cell Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo blood and CSF sample collection
- Bone Marrow Aspiration — PROCEDUREUndergo bone marrow biopsy and aspiration
- Bone Marrow Biopsy — PROCEDUREUndergo bone marrow biopsy and aspiration
- Computed Tomography — PROCEDUREUndergo CT or PET/CT
- Cyclophosphamide — DRUGGiven IV
- Doxorubicin Hydrochloride — DRUGGiven IV
- Echocardiography Test — PROCEDUREUndergo ECHO
- Etoposide Phosphate — DRUGGiven IV
- Filgrastim — BIOLOGICALGiven SC
- Lumbar Puncture — PROCEDUREUndergo LP
- Nivolumab — BIOLOGICALGiven IV
- Pegfilgrastim — BIOLOGICALGiven SC
- Positron Emission Tomography — PROCEDUREUndergo PET/CT
- Prednisolone — DRUGGiven PO
- Prednisone — DRUGGiven PO
- Radiation Therapy — RADIATIONUndergo radiation therapy
- Rituximab — BIOLOGICALGiven IV
- Rituximab and Hyaluronidase Human — BIOLOGICALGiven SC
- Vincristine Sulfate — DRUGGiven IV
Study Details
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
Key Dates
- Start date
- Oct 5, 2021
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 244 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Arm A (DA-EPOCH-R)See Detailed Description
- Experimental: Arm B (DA-EPOCH-R, nivolumab)Patients receive treatment as in Arm A. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO and LP for CSF collection during screening. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
- Active Comparator: Arm C (R-CHOP)Patients receive prednisone or prednisolone PO QD on days 1-5 and rituximab IV or rituximab and hyaluronidase human SC over 5 minutes on day 1 or 5. Patients also receive cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV over 1-15 minutes or up to 60 minutes, and vincristine sulfate IV over 1 or up to 60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
- Experimental: Arm D (R-CHOP, nivolumab)Patients receive treatment as in Arm C. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
- Active Comparator: Arm E (R-CHOP, radiation therapy)Patients receive treatment as in Arm C. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
- Experimental: Arm F (R-CHOP, nivolumab, radiation therapy)Patients receive treatment as in Arm D. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions. Patients undergo ECHO during screening and as clinically indicated and LP for CSF collection optionally during screening. Patients also undergo CT or PET/CT throughout the trial. Additionally, patients undergo bone marrow biopsy and aspiration optionally during screening and as clinically indicated on study. Patients undergo blood sample collection on study.
Primary Outcome Measure
Progression-free survival (PFS) [ Time Frame: From enrollment on the study to first occurrence of relapse/progression or death, assessed up to 7 years ]
Locations (215)
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