Nivolumab + Lenalidomide for Lymphoma

Recruiting at 1 trial location

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: David Bond, MD

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 12 courses (approximately 48 weeks)

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the combination of lenalidomide and nivolumab for patients with non-Hodgkin or Hodgkin lymphoma that has come back and does not respond to treatment. Lenalidomide works by killing or stopping the growth of cancer cells, while nivolumab helps the immune system attack the cancer. The goal is to find the best dose and see how well this combination works. Lenalidomide has shown significant activity in some subtypes of lymphoma, and combining it with other treatments like rituximab has been promising.

Research Team

David Bond, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients with certain types of B-cell non-Hodgkin or Hodgkin lymphoma that have relapsed or are not responding to treatment. Participants must be able to consent, follow study procedures, use contraception if applicable, and not be pregnant. They should also meet specific health criteria and not have received certain treatments recently.

Inclusion Criteria

Male subjects should agree to use contraception

You have been diagnosed with Hodgkin's disease and it has come back or not responded to at least one round of chemotherapy.

You have been diagnosed with classical or lymphocyte-predominant Hodgkin's disease.

Exclusion Criteria

Is unable to swallow capsules or has malabsorption syndrome

You currently have active tuberculosis.

You are allergic to certain medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lenalidomide orally on days 1-21 and nivolumab intravenously on days 1 and 15 of courses 1-4 and on day 1 of courses 5-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Up to 12 courses (approximately 48 weeks)

In-person visits on days 1 and 15 of courses 1-4, and day 1 of courses 5-12

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months for 2 years, then every 6 months for up to 3 years

Treatment Details

Interventions

• Lenalidomide
• Nivolumab

Trial Overview The trial is testing the combination of Nivolumab (a monoclonal antibody) and Lenalidomide (a chemotherapy drug) to see how well they work together in treating lymphoma. It aims to find the best dose with acceptable side effects for patients whose disease has returned after previous treatments.

Participant Groups

Group I: Treatment (lenalidomide, nivolumab) Experimental Treatment 3 Interventions

Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 60 minutes on days 1 and 15 of courses 1-4 and on day 1 of courses 5-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Lenalidomide is already approved in European Union, United States for the following indications:

Approved in European Union as Revlimid for:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma
• Marginal zone lymphoma

Approved in United States as Revlimid for:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma
• Marginal zone lymphoma

Who Is Running the Clinical Trial?

David Bond, MD

Lead Sponsor

Trials

4

Recruited

110+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania