Trial purpose
Cancer treatment
Tumor type
Haematological
Age
2+
Clinical summary
Summary
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 primary mediastinal B-cell lymphoma (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, which 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 people with PMBCL.
Eligible participants will be randomly allocated to one of six treatment arms.
- In Arm A, participants will receive DA-EPOCH-R chemo-immunotherapy regimen.
- In Arm B, participants will receive DA-EPOCH-R chemo-immunotherapy regimen plus nivolumab immunotherapy.
- In Arm C, participants will receive R-CHOP chemo-immunotherapy regimen.
- In Arm D, participants will receive R-CHOP chemo-immunotherapy regimen plus nivolumab immunotherapy.
- In Arm E, participants will receive R-CHOP chemo-immunotherapy regimen plus radiation therapy.
- In Arm F, participants will receive R-CHOP chemo-immunotherapy regimen, plus nivolumab immunotherapy and radiation therapy.
After completion of the study treatment, participants are followed up every 3 months for year 1, every 6 months for years 2-3, and annually thereafter.
Conditions
This trial is treating people with primary mediastinal B-cell lymphoma
Eligibility
Inclusion
- Age >= 2 years
- Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or ECOG performance status of 3 if poor performance is related to lymphoma
- Children's Oncology Group (COG) Institutions: Use Karnofsky for patients >= 17 and < 18 years of age and Lansky for patients < 17 years of age
- Adults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
-
Pediatric Patients (age < 18 years): The following must have been obtained within 14 days prior to registration:
- Patients with abnormal liver function will be eligible to enroll if the lab abnormality is thought to be due to the lymphoma or Gilbert's syndrome
- Age >= 18 years: Ejection fraction of >= 50% by echocardiogram
- Age < 18 years: Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Inclusion
- You are able to swallow medication by mouth.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
National Cancer Institute (NCI)
Scientific Title
A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
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