Nivolumab for Relapsed or Resistant Blood Cancers

Palo Alto (17 mi)

Overseen byAndrew Cowan, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Washington

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 jurisdictions

Trial Summary

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.

Eligibility Criteria

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.

My cancer can be measured and tracked.

I haven't had any treatments after my CAR T-cell therapy.

I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

I am HIV positive.

I have received treatment after my CAR T-cell therapy.

I do not have any infections that are currently uncontrolled.

I have had another cancer that has been in remission for less than a year.

I am experiencing symptoms of cytokine release syndrome.

My cancer has spread to my brain or spinal cord.

I have an active lung infection.

I haven't taken steroids or immunosuppressants in the last 14 days.

Treatment Details

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.

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab)Experimental Treatment1 Intervention

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

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

🇺🇸 Approved in United States as Opdivo for: