Study on Nivolumab After Partially Matched Bone Marrow Transplant in Children and Adults with Sarcoma

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03465592

Provider View

This clinical trial is testing if the drug Nivolumab can be safely given after a partially matched bone marrow transplant to help prevent or delay the return or worsening of sarcoma, a type of cancer. The study also aims to understand how Nivolumab affects blood and tumors.

Patient Parameters

Program Overview

The purpose of this study is to find out if Nivolumab, an investigational drug, can be safely used after a 'half-matched' bone marrow transplant in patients with sarcoma. Researchers want to see if this drug can help prevent or delay the cancer from coming back or getting worse. Participants in this study are those who have recently had a 'half-matched' bone marrow transplant and are either at high risk of their cancer returning or have already experienced a relapse.

Description

Sarcomas are a type of cancer that can be very difficult to treat, especially in children, teenagers, and young adults. Despite intensive treatments, the outlook for these patients is often poor. Johns Hopkins has developed a method using a partially matched bone marrow transplant to help treat these patients. This method uses a less intense preparation process and a donor who is a partial match. The goal is to make the transplant safer and more effective.

In this study, researchers are testing if adding Nivolumab, a drug that blocks a protein called PD-1, can improve the effectiveness of the transplant. PD-1 is a protein that can stop the immune system from attacking cancer cells. By blocking PD-1, Nivolumab may help the immune system fight the cancer more effectively.

The study will first test Nivolumab in patients whose cancer has returned after the transplant (Part A) and then in patients who are at high risk of relapse but have not yet relapsed (Part B). The main goal is to see if Nivolumab is safe and well-tolerated after the transplant.

Eligibility Criteria

Inclusion Criteria

  • Age between 12 months and 50 years.
  • Have a confirmed diagnosis of a solid tumor with a poor long-term survival outlook.
  • Have a performance status score of at least 50% for those over 16 years old, and at least 60% for those 16 years old or younger.
  • Have undergone a 'half-matched' bone marrow transplant.
  • Have recovered from the immediate side effects of the transplant.
  • Can receive radiation therapy as part of the study.
  • Agree to provide a tumor sample for research purposes.
  • Have adequate blood, kidney, and liver function as determined by specific medical tests.
  • Must have been part of a previous related study and can start the study drug on or after 120 days post-transplant.

Exclusion Criteria

  • History of severe graft-versus-host disease (GVHD) or currently have mild GVHD and are on immunosuppressive therapy.
  • Have had certain severe side effects from the transplant, such as lung or liver issues, and are still on treatment for these.
  • Have an uncontrolled infection.
  • Have an active autoimmune disease, except for certain conditions like vitiligo or type I diabetes.
  • Have allergies to the study drug or similar medications.
  • Women who are pregnant or breastfeeding, or who do not agree to use contraception during and after the study.
  • Men who do not agree to use contraception during and after the study.

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