Study on Nivolumab for Blood Cancers That Have Returned or Are Still Detectable After CAR T-Cell Treatment

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04205409

Provider View

This clinical trial is testing how well the drug nivolumab works for treating blood cancers that have come back, do not respond, or are still detectable after CAR T-cell therapy. Nivolumab is an immunotherapy that may help the immune system attack cancer cells and stop them from growing.

Patient Parameters

Program Overview

This phase II study is exploring the effectiveness of nivolumab, an immunotherapy drug, in treating blood cancers that have relapsed, are resistant to treatment, or are still present after CAR T-cell therapy. Nivolumab works by helping the immune system target and destroy cancer cells, potentially preventing them from growing and spreading.

Description

In this study, patients will receive nivolumab through an IV infusion over 30 minutes on the first day of each cycle. These cycles will repeat every 28 days as long as the disease does not progress and the patient does not experience unacceptable side effects. After finishing the treatment, patients will be monitored for 30 days and then followed up for up to 5 years to track their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific types of blood cancers, such as Non-Hodgkin's lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma.
  • The cancer must have returned, not responded, or still be detectable after CAR T-cell therapy.
  • For Multiple Myeloma, patients must have tried all known beneficial treatments and be resistant to at least three prior therapies.
  • Have measurable disease based on specific medical criteria.
  • Be 18 years or older and able to give informed consent.
  • Expected to live for more than 3 months.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Allowed to have received palliative radiation therapy after CAR T-cell treatment.
  • Have adequate kidney and liver function as shown by specific blood tests.
  • Have sufficient blood cell counts, including neutrophils, platelets, and hemoglobin.

Exclusion Criteria

  • Have received other treatments after CAR T-cell therapy.
  • Have another primary cancer that has not been in remission for at least 1 year, except for certain skin, prostate, bladder, or cervical cancers.
  • Have active hepatitis B or C, or HIV.
  • Have an uncontrolled infection.
  • Are using other cancer treatments or experimental drugs.
  • Have an active autoimmune disease needing immunosuppressive therapy, except for vitiligo and autoimmune alopecia.
  • Have active cancer in the central nervous system.
  • Require systemic treatment with corticosteroids or other immunosuppressive medications, except for certain low-dose or topical treatments.
  • Have a history of infectious lung disease.
  • Have graft-versus-host disease needing active treatment, unless limited to skin and managed with topical steroids.
  • Have active cytokine release syndrome.
  • Are pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective contraception during the study and for 8 months after the last dose of nivolumab.

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