Study on Brentuximab Vedotin and Nivolumab for Treating Relapsed or Resistant Classical Hodgkin Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04561206

Provider View

This clinical trial is testing how well the combination of brentuximab vedotin and nivolumab works in patients with classical Hodgkin lymphoma that has returned after treatment or did not respond to initial treatment. The study aims to see if this combination can delay the need for stem cell transplants, which are costly and have significant side effects.

Patient Parameters

Program Overview

This phase II study is exploring the effectiveness of two drugs, brentuximab vedotin and nivolumab, in treating classical Hodgkin lymphoma that has either come back after initial treatment or did not respond to it. Brentuximab vedotin targets and kills cancer cells, while nivolumab boosts the immune system to fight the cancer. The goal is to see if this combination can help patients avoid the need for a stem cell transplant, which can be expensive and have serious side effects.

Description

The main goal of this study is to see how long the response to the treatment lasts, specifically looking at how many patients remain free of disease progression for 24 months after achieving an early complete response.

Secondary goals include:

  • Measuring the complete response rate and overall response rate after four cycles and at the end of treatment.
  • Evaluating the progression-free survival and overall survival for all patients and specific subgroups.
  • Assessing the safety and side effects of the treatment.

Exploratory goals include:

  • Estimating the progression-free survival after additional therapy for patients whose disease progresses after the study treatment.
  • Investigating the relationship between clinical outcomes and tumor characteristics.
  • Exploring the link between clinical outcomes and circulating tumor DNA features.

Patients will receive brentuximab vedotin and nivolumab through an IV every 21 days for up to 16 cycles, as long as the disease does not progress and side effects are manageable. After completing the treatment, patients will have follow-up visits at 30 days and then at 6, 12, 18, 24, 36, 48, and 60 months.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent and, if applicable, assent.
  • Willing to provide a tissue sample from a biopsy done after initial treatment and before starting the study treatment.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Diagnosed with classical Hodgkin lymphoma, excluding nodular lymphocyte predominant Hodgkin lymphoma.
  • Disease must have returned or not responded after no more than one prior treatment line, excluding radiotherapy. Up to five patients with primary refractory disease may be included.
  • Not eligible for a stem cell transplant due to age, other health conditions, or personal choice.
  • Have measurable disease, with at least one tumor that can be tracked using standard criteria.
  • Meet specific blood count and organ function requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for at least 5 months after the last dose. Men must agree to use birth control for at least 7 months after the last dose.

Exclusion Criteria

  • Currently receiving another investigational therapy.
  • Have received a live vaccine within 30 days before starting the study treatment.
  • Have significant nerve damage (grade 2 or higher).
  • Have had severe allergic reactions to brentuximab vedotin or nivolumab.
  • Have active central nervous system involvement by lymphoma.
  • Have another primary cancer that has not been in remission for at least 3 years, with some exceptions.
  • Require systemic treatment with corticosteroids or other immunosuppressive medications, with some exceptions.
  • Have a history of progressive multifocal leukoencephalopathy.
  • Have an inherited or acquired immunodeficiency.
  • Have active lung disease or pneumonitis.
  • Have active autoimmune disease, with some exceptions.
  • Have active hepatitis B or C, or HIV infection, unless well-controlled.
  • Have had a recent stroke, heart attack, or severe heart symptoms.
  • Are pregnant or breastfeeding.
  • Have any other condition that would make participation unsafe or difficult.

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