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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
Have evaluable disease
PHASE I: Histologically confirmed B-cell NHL with specified subtypes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial studies the side effects and best dose of lenalidomide when given with nivolumab to treat patients with non-Hodgkin or Hodgkin lymphoma.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a disease that can be measured or evaluated.
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You have a specific type of B-cell non-Hodgkin lymphoma confirmed by a tissue sample.
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You have been diagnosed with Hodgkin's disease and it has come back or not responded to at least one round of chemotherapy.
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You must have tried at least one treatment before. If you've had a stem cell transplant, that's okay. But if you've already tried lenalidomide and it didn't work, you can't participate.
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You have been diagnosed with classical or lymphocyte-predominant Hodgkin's disease.
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You must have tried at least one treatment before. If you have had a stem cell transplant, that's okay. But if you have already tried lenalidomide and it didn't work, you can't participate.
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You are able to carry out daily activities with little or no difficulty.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Complete response rate (CR) in patients
Overall Response Rate (ORR)
Overall Survival (OS)
+1 more

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
~1480
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,500 Total Patients Enrolled
David Bond, MDLead Sponsor
3 Previous Clinical Trials
74 Total Patients Enrolled

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03015896 — Phase 1 & 2
Follicular Lymphoma Research Study Groups: Treatment (lenalidomide, nivolumab)
Follicular Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT03015896 — Phase 1 & 2
Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03015896 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Lenalidomide been examined in other research efforts?

"Lenalidomide first entered clinical trials in 2004 at the Midwest Center for Hematology Oncology. To date, there are 1142 concluded studies and 983 active ones, with some of these occurring around Atlanta."

Answered by AI

What is the population size for this experimental treatment?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively in search of participants; it was published on February 14th 2017 and the latest update was May 31st 2022. 102 individuals need to be recruited from two different locations for data collection purposes."

Answered by AI

Are there any remaining vacancies for participants in this trial?

"This clinical trial remains in the process of recruitment, as indicated on its listing on clinicaltrials.gov. This research project was first posted to the public domain on February 14th 2017 and has seen an update since May 31st 2022."

Answered by AI

What medical conditions can be effectively addressed by lenalidomide?

"Lenalidomide is often prescribed to patients who have gone through multiple prior systemic chemotherapy regimens. Moreover, it has also been found to be effective in treating malignant neoplasms and skin conditions like unresectable melanoma and squamous cell carcinoma."

Answered by AI

What is the primary mission of this clinical experiment?

"According to Bristol-Myers Squibb, the trial's sponsor, their primary outcome of measure over a 28 day period is Adverse Events' Incidence as defined by NCI CTCAE version 4. Additionally, Secondary Outcomes encompassing Overall Response Rate (ORR), Overall Survival (OS) and Complete Response Rate (CR) in patients will be monitored for this experiment."

Answered by AI
~4 spots leftby Mar 2025