Study on Nivolumab and Axatilimab Combination for Patients with Difficult or Returning Classical Hodgkin Lymphoma

Sponsor: University of Utah

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05723055

Provider View

This clinical trial is exploring a new treatment combination of nivolumab and axatilimab for patients with classical Hodgkin Lymphoma that has not responded to previous treatments or has returned. The study aims to see if this combination is effective.

Patient Parameters

Program Overview

The purpose of this study is to test a new combination of drugs, nivolumab and axatilimab, in patients with classical Hodgkin Lymphoma that has either not responded to previous treatments or has come back. Researchers want to see if this combination works as expected in helping to control the disease.

Description

This study is a Phase II trial, meaning it is in the early stages of testing this new treatment combination. It involves multiple centers and will include up to 12 patients. Participants will receive axatilimab and nivolumab every four weeks. If side effects are too severe in the first few patients, the dose of axatilimab may be reduced. The treatment will continue for up to 12 months unless the disease progresses or side effects become too severe. Researchers believe that if the treatment is effective, it will change the tumor environment to make it more responsive to treatment. After 12 months, patients who respond well may continue with anti-PD(L)1 therapy outside of the study. The study will also determine the safest dose for future research. Safety and tolerability are key focuses, and the study may adjust doses based on patient responses.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have classical Hodgkin Lymphoma that has returned or not responded to at least one previous treatment.
  • Have tried anti-PD-1/PD-L1 therapy and either had a partial response, stable disease, or progression.
  • Must have at least one measurable tumor.
  • If previously had a stem cell transplant, it must have been at least 90 days ago, and no immunosuppressive drugs for at least 2 months.
  • Good overall health with an ECOG score of 0 to 2.
  • Adequate organ function without recent transfusions or growth factors.
  • Women must not be pregnant and must use effective birth control.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have an immune system deficiency or are on immunosuppressive therapy.
  • Previously treated with certain immune-modulating drugs.
  • Have unresolved side effects from previous treatments, except for certain conditions like mild neuropathy or hair loss.
  • Have a history of severe immune-related side effects from previous treatments.
  • Have an autoimmune disease, except for certain controlled conditions.
  • Have significant lung disease or other serious health conditions.
  • Have had recent major surgery or radiation therapy.
  • Have another active cancer within the last 2 years, except for certain treated cancers.
  • Have brain metastases unless treated and stable.
  • Have uncontrolled health issues that could interfere with the study.
  • Have an active infection, including HIV with a detectable viral load.
  • Have significant liver disease.
  • Have a known allergy to nivolumab or axatilimab.
  • Taking medications that are not allowed in the study.

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