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Chemotherapy

Nivolumab + Chemo-Immunotherapy for Large B-Cell Lymphoma

Phase 3

Recruiting

Led By Lisa G Roth

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 2 years

Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria

Must not have

A single course of COP (cyclophosphamide, vincristine, and prednisone)

Active ischemic heart disease or heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone to see how well they work in treating PMBCL.

Who is the study for?

This trial is for people with newly diagnosed primary mediastinal B-cell lymphoma. Eligible participants include children over 2 years old and adults with good kidney function, no severe liver issues unrelated to lymphoma, and a stable heart condition. HIV-positive patients can join if they have an undetectable viral load. Pregnant women, breastfeeding mothers, those with active autoimmune diseases or infections, and individuals who've had certain recent cancer treatments are excluded.

What is being tested?

The study tests nivolumab combined with chemo-immunotherapy against chemo-immunotherapy alone in treating primary mediastinal B-cell lymphoma. Nivolumab is an immunotherapy drug that may help the immune system fight cancer by stopping cancer cells from growing.

What are the potential side effects?

Potential side effects of nivolumab and other drugs used in this trial might include allergic reactions to the medication, increased risk of infection due to weakened immunity, fatigue, possible damage to organs like the liver or kidneys from chemotherapy drugs, and heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 2 years old.

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My lymphoma is confirmed as PMBCL by WHO standards.

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My kidney function, measured by creatinine clearance or GFR, is good.

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My kidney function, measured by creatinine, is within the normal range for my age and gender.

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I am between 2 and 6 years old with a creatinine level at or below 0.8 mg/dL.

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I am between 6 and 9 years old with a creatinine level of 1 or less.

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I am between 10 and 12 years old with a creatinine level at or below 1.2 mg/dL.

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I am between 13 and 16 years old with a creatinine level below the gender-specific limit.

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I am between 16 and 18 years old with a creatinine level below the gender-specific limit.

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I am 18 or older with a healthy heart pump function.

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I am under 18 and my heart functions well according to tests.

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My hepatitis B virus load is undetectable with treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have completed one round of COP chemotherapy.

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I have heart disease or heart failure that is currently causing symptoms.

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I currently have an infection that isn't under control.

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My lymphoma has spread to my brain or spinal cord.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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I am under 18 and have had or currently have hepatitis B.

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I am not pregnant and can take a pregnancy test if needed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Efficacy-related event-free survival

Overall survival

Positron-Emission Tomography

+1 more

Other study objectives

Complete response rate

Immune profile of patients treated with nivolumab + chemo-immunotherapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Arm F (R-CHOP, nivolumab, radiation therapy)Experimental Treatment15 Interventions

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.

Group II: Arm D (R-CHOP, nivolumab)Experimental Treatment15 Interventions

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.

Group III: Arm B (DA-EPOCH-R, nivolumab)Experimental Treatment18 Interventions

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.

Group IV: Arm C (R-CHOP)Active Control14 Interventions

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.

Group V: Arm A (DA-EPOCH-R)Active Control17 Interventions

See Detailed Description

Group VI: Arm E (R-CHOP, radiation therapy)Active Control15 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Biospecimen Collection

2004

Completed Phase 3

~2030