Study on Nivolumab, Ifosfamide, Carboplatin, and Etoposide for Treating Difficult or Returning Hodgkin Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT03016871

This clinical trial is testing a combination of drugs, including nivolumab, ifosfamide, carboplatin, and etoposide, to see if they can effectively treat Hodgkin lymphoma that has returned or is not responding to previous treatments.

Patient Parameters

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Program Overview

The purpose of this study is to evaluate the effectiveness and safety of a combination of drugs, including nivolumab, ifosfamide, carboplatin, and etoposide, in treating patients with Hodgkin lymphoma that has come back or is not responding to treatment. Nivolumab is an immunotherapy drug that helps the immune system attack cancer cells, while the other drugs are chemotherapy agents that stop cancer cells from growing and spreading.

Description

This study aims to find out how well the combination of nivolumab and chemotherapy drugs (ifosfamide, carboplatin, and etoposide) works in treating Hodgkin lymphoma that has returned or is not responding to treatment. The study will also look at the side effects of this treatment.

Participants will be divided into two groups:

Cohort A: Patients will receive nivolumab every two weeks for six weeks. If the cancer responds well, they may continue with nivolumab. If the cancer is stable or worsens, they may receive additional chemotherapy with ifosfamide, carboplatin, and etoposide.
Cohort B: Patients will start with nivolumab and then receive the combination of nivolumab, ifosfamide, carboplatin, and etoposide every three weeks.

The study will monitor the effectiveness of the treatment, the side effects, and how long patients remain free of cancer. After completing the treatment, patients will have follow-up visits every three months for up to two years.

Eligibility Criteria

Inclusion Criteria

Diagnosed with Hodgkin lymphoma that has returned or is not responding to initial treatment.
Weigh more than 40 kg (about 88 pounds).
Have certain blood cell counts and organ function levels within specified limits.
Have a life expectancy of more than three months.
Be in good overall health with an ECOG performance status of 0 to 2.
Women must not be pregnant and must agree to use effective birth control during the study.
Men must agree to use birth control if they are sexually active with women who can become pregnant.
Must provide informed consent to participate in the study.

Exclusion Criteria

Have previously received PD-1 or PD-L1 inhibitors.
Have had second-line chemotherapy for Hodgkin lymphoma.
Have active autoimmune diseases requiring treatment.
Have received a live vaccine within four weeks of starting the study.
Have any serious medical conditions that could affect safety or study results.
Are unable to participate in all study procedures.
Have uncontrolled illnesses or infections.
Have had a heart attack or severe heart problems recently.
Have significant lung problems or other cancers within the past three years.
Are pregnant or breastfeeding.
Have a history of certain viral infections like HIV or hepatitis.

Locations

FACILITY	ZIP	CITY	STATE
City of Hope Medical Center	91010	Duarte	California
Yale University	06520	New Haven	Connecticut
M D Anderson Cancer Center	77030	Houston	Texas
Fred Hutchinson Cancer Research Center	98109	Seattle	Washington

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