What side effects are associated with this type of intervention?

Lenalidomide, a chemotherapy agent, commonly causes side effects such as fatigue, diarrhea, constipation, nausea, and an increased risk of infections due to lowered blood cell counts. Nivolumab, a monoclonal antibody, is associated with immune-related side effects including skin reactions, endocrine disorders, and gastrointestinal issues like diarrhea and colitis. Both treatments can lead to more severe adverse effects, such as serious infections and organ-specific toxicities, which require close monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for Follicular Lymphoma that are similar to Lenalidomide and Nivolumab. Lenalidomide, in combination with Rituximab, has been approved for previously treated Follicular Lymphoma. Rituximab is a monoclonal antibody that targets CD20 on B-cells, similar to how Nivolumab targets PD-1 on tumor cells. Additionally, Obinutuzumab, another monoclonal antibody targeting CD20, has been approved in combination with chemotherapy for untreated Follicular Lymphoma. These treatments reflect the use of both chemotherapy agents and monoclonal antibodies in managing the disease.

What other types of research exist?

Promising novel alternatives for Follicular Lymphoma patients include: 1) CAR T-cell therapies such as Axicabtagene Ciloleucel and Tisagenlecleucel, which have shown high response rates in relapsed or refractory cases. 2) Bispecific antibodies like Mosunetuzumab, targeting CD20 and CD3, which have demonstrated encouraging efficacy in clinical trials. 3) Novel PI3K inhibitors such as Umbralisib, which offer a targeted approach with a favorable safety profile. These therapies represent significant advancements and are expected to be important options for treatment in 2024.

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Immunomodulatory Agent

Nivolumab + Lenalidomide for Lymphoma

Phase 1 & 2

Waitlist Available

Research Sponsored by David Bond, MD

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to the immune system attacking normal cells, increased risk of infections, blood clots, allergic responses to medication components, fatigue from anemia or other blood cell changes, and possible interference with organ function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Incidence of adverse events summarized by NCI CTCAE version 4

Maximum tolerated dose (MTD) defined as the dose level at which no more than one of 6 patients experiences a dose-limiting toxicity summarized by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4

Secondary study objectives

Complete response rate (CR) in patients

Overall Response Rate (ORR)

Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (lenalidomide, nivolumab)Experimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~2240

Nivolumab

2015

Completed Phase 3

~4010

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lenalidomide and Nivolumab are common treatments for Follicular Lymphoma, each with distinct mechanisms of action. Lenalidomide is a chemotherapy agent that kills tumor cells, inhibits their division, and prevents their spread, thereby directly reducing the tumor burden. Nivolumab, on the other hand, is a monoclonal antibody that targets immune checkpoint pathways, specifically interfering with proteins that allow tumor cells to evade the immune system. This dual approach is significant for Follicular Lymphoma patients as it combines direct tumor cell eradication with enhanced immune system activity against the cancer, potentially leading to more effective disease control and longer remission periods.

Double-hit follicular lymphoma with MYC and BCL2 translocations: a study of 7 cases with a review of literature.