20 Participants Needed

Nivolumab for Relapsed or Resistant Blood Cancers

AC
Overseen ByAndrew Cowan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well nivolumab works for the treatment of hematological malignancies that have come back (relapsed), does not respond (refractory), or is detectable after CAR T cell therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot use other anticancer agents or experimental treatments while participating, and you should not be on systemic corticosteroids or immunosuppressive medications within 14 days of starting the study drug.

Is Nivolumab generally safe for humans?

Nivolumab, also known as Opdivo, has been associated with some serious side effects, including hematological toxicities (blood-related issues) and immune-related adverse events. There have also been reports of hepatitis B reactivation in patients treated with Nivolumab, which can lead to treatment delays or discontinuation. However, it has shown improved tolerability compared to some standard chemotherapy treatments in certain cancers.12345

How is the drug Nivolumab unique for treating relapsed or resistant blood cancers?

Nivolumab is unique because it is a PD-1 inhibitor, which helps the immune system recognize and attack cancer cells, and it is used when other treatments have failed or are not suitable. This approach is different from traditional chemotherapy, which directly targets and kills cancer cells.678910

Who Is on the Research Team?

AC

Andrew Cowan, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for adults with certain blood cancers like Non-Hodgkin's lymphoma and Chronic lymphocytic leukemia that have returned or didn't respond after CAR T-cell therapy. Participants must not be pregnant, agree to use contraception, and should not have HIV, active infections, or require immunosuppressive drugs.

Inclusion Criteria

My cancer returned or didn't respond after CAR T-cell therapy.
I have been diagnosed with Non-Hodgkin lymphoma or Chronic lymphocytic leukemia.
I am over 18 and can understand and agree to the study's details.
See 6 more

Exclusion Criteria

I am HIV positive.
I am being treated for GVHD, but it's only on my skin and managed with creams.
I have received treatment after my CAR T-cell therapy.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive nivolumab intravenously over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Long-term Follow-up

Participants are followed up for overall survival and progression-free survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Nivolumab
Trial Overview The study tests Nivolumab in patients whose hematologic malignancies relapsed or are detectable post CAR T-cell treatment. It's a phase II trial to see if this monoclonal antibody can help the immune system fight cancer by stopping tumor growth.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab)Experimental Treatment1 Intervention

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

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Approved in United States as Opdivo for:
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Approved in European Union as Opdivo for:
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Approved in Canada as Opdivo for:
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Approved in Switzerland as Opdivo for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

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 profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

Published Research Related to This Trial

In a meta-analysis of five studies involving 2399 patients, nivolumab was found to significantly lower the risk of hematological toxicities such as anemia, neutropenia, and leukopenia compared to other treatments.
The relative risks for these conditions were notably low, indicating that nivolumab may be a safer option regarding hematological side effects, which is important for clinicians when considering treatment options.
The risks of hematological toxicities of nivolumab in cancer patients: A PRISMA-compliant meta-analysis.Shi, Z., Liu, X., Chen, M., et al.[2023]
A retrospective analysis of adverse events related to PD-1/PD-L1 inhibitors revealed a significant association between Pembrolizumab and hepatitis B reactivation (HBVr), with a reporting odds ratio of 2.32, indicating a higher risk compared to other treatments.
No cases of HBVr were reported with Ipilimumab or Avelumab, suggesting that not all immune checkpoint inhibitors carry the same risk, highlighting the need for further prospective studies to confirm these findings.
Hepatitis B Virus Reactivation in Cancer Patients Treated With Immune Checkpoint Inhibitors.Burns, EA., Muhsen, IN., Anand, K., et al.[2023]
Monoclonal antibodies like nivolumab and pembrolizumab, which target PD-1, have shown a survival benefit and better tolerability compared to standard second-line chemotherapy in non-small cell lung cancer, as demonstrated in three phase III trials.
Patients receiving PD-1 inhibitors may experience unique immune-related adverse events that require early recognition and a multidisciplinary management approach, highlighting the need for ongoing education among healthcare providers.
Monitoring and Management of Immune-Related Adverse Events Associated With Programmed Cell Death Protein-1 Axis Inhibitors in Lung Cancer.O'Kane, GM., Labbé, C., Doherty, MK., et al.[2018]

Citations

The risks of hematological toxicities of nivolumab in cancer patients: A PRISMA-compliant meta-analysis. [2023]
Hepatitis B Virus Reactivation in Cancer Patients Treated With Immune Checkpoint Inhibitors. [2023]
Monitoring and Management of Immune-Related Adverse Events Associated With Programmed Cell Death Protein-1 Axis Inhibitors in Lung Cancer. [2018]
Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting. [2021]
Immune-related adverse events are clinical biomarkers to predict favorable outcomes in advanced renal cell carcinoma treated with nivolumab plus ipilimumab. [2022]
Nivolumab: a review in advanced squamous non-small cell lung cancer. [2022]
Antitumor activity of nivolumab on hemodialysis after renal allograft rejection. [2023]
An update on the pharmacodynamics, pharmacokinetics, safety and clinical efficacy of nivolumab in the treatment of solid cancers. [2018]
Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study. [2019]
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