Nivolumab + Lenalidomide for Lymphoma

Not currently 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

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Active infection, Autoimmune disease, Cardiovascular disease, others

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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine the optimal dose and examine the effects of combining lenalidomide and nivolumab for treating non-Hodgkin or Hodgkin lymphoma that has returned or resisted treatment. Nivolumab, a monoclonal antibody, may inhibit tumor cell growth and spread, while lenalidomide, a chemotherapy drug, can kill tumor cells or prevent their growth. The trial seeks participants whose lymphoma has not improved with previous treatments and who have specific types of lymphoma, such as non-Hodgkin or Hodgkin types. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before starting the trial treatment, except for low-dose steroids or topical/inhaled corticosteroids.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining nivolumab and lenalidomide yields promising safety results for treating Hodgkin lymphoma. Studies found that many patients experienced positive outcomes, and the treatment was generally well-tolerated. While some side effects occurred, they were mostly manageable, indicating the treatment does not cause severe harm. However, as this study is in the early stages, further research is needed to fully understand the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Nivolumab and Lenalidomide for treating lymphoma because it introduces a unique approach by combining an immunotherapy with an immune-modulating agent. Nivolumab, an immune checkpoint inhibitor, works by unleashing the body's immune system to attack cancer cells, which is different from traditional chemotherapy that directly targets and kills cancer cells. Lenalidomide, on the other hand, enhances the immune system's response and possesses anti-angiogenic properties, which can cut off the blood supply to tumors. This dual-action approach not only aims to boost the immune system's ability to fight lymphoma but also potentially offers a more targeted and less toxic alternative to standard chemotherapy regimens.

What evidence suggests that nivolumab and lenalidomide might be an effective treatment for lymphoma?

This trial will evaluate the combination of lenalidomide and nivolumab for treating certain types of lymphoma. Research has shown that using lenalidomide with nivolumab can help treat these conditions. In one study, a low dose of nivolumab combined with lenalidomide led to a 90% overall response rate in patients with classical Hodgkin lymphoma, meaning that most patients saw their cancer respond to the treatment. Nivolumab helps the immune system find and attack cancer cells, while lenalidomide stops cancer cells from growing and spreading. Together, these treatments show promise for patients whose lymphoma has returned or is difficult to treat. ^{1 2 4 6 7}

Who Is on the Research Team?

David Bond, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10905073/

A phase II study of interrupted and continuous dose ... Newly diagnosed classical Hodgkin lymphoma (cHL) can be cured in approximately 75–85% of patients with systemic or combined-modality frontline therapy.

2. targetedonc.com targetedonc.com/view/low-dose-nivolumab-offers-novel-strategy-for-hodgkin-lymphoma-treatment

Low-Dose Nivolumab Offers Novel Strategy for Hodgkin ... Low-dose nivolumab plus lenalidomide achieved a 90% overall response rate in classical Hodgkin lymphoma patients, with a favorable safety ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03015896

Nivolumab and Lenalidomide in Treating Patients With ... This I/II trial studies the side effects and best dose of lenalidomide when given together with nivolumab and to see how well they work in treating patients ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7534065/

Low dose continuous lenalidomide in heavily pretreated ... Among the 19 patients included in this analysis, 11% of patients achieved a partial response (PR), with no documented complete responses (CR). A total of 12 (63 ...

5. ashpublications.org ashpublications.org/bloodict/article-pdf/doi/10.1016/j.bict.2025.100011/2414524/bict_ict-2025-000152-main.pdf

Low-dose Nivolumab and Lenalidomide in Relapsed ... Low dose Nivolumab has clinical efficacy in Hodgkin lymphoma and is a cost-effective alternative to standard dosing. ABSTRACT: Based on previous reports of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5645787/

Efficacy and toxicity of therapy immediately after treatment ... Data collected included age, number of lines of therapy prior to nivolumab, presence of high-risk cytogenetic abnormalities according to 2016 IMWG consensus ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124058002

A Comparison of Standard Dose and Low Dose Nivolumab ... The data presented here describes clinical outcomes in refractory Hodgkin lymphoma at a lower, off-label dose of nivolumab (40mg). Context ...