RecruitingPhase 1Phase 2NCT03465592

Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma

Single-arm, Open-label, Phase 1b/2 Trial of Nivolumab Therapy Following Partially HLA Mismatched (Haploidentical) Bone Marrow Transplant in Children and Young Adults With High Risk, Recurrent or Refractory Sarcomas

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

39 participants

Start Date

May 1, 2018

Study Type

INTERVENTIONAL

Conditions

Sarcoma Solid Tumor, Adult Solid Tumor, Childhood

Summary

This research is being done to find out if an investigational drug, Nivolumab, can be safely administered after a "half-matched" (haplo) bone marrow transplant (BMT), and if the investigational drug will help to prevent or delay relapse or progression of sarcomas. In this study investigators will also be trying to learn more about how the investigational drug changes blood and/or tumors. Participants are eligible for this trial if they have recently undergone a "half-matched" (haplo) bone marrow transplant and have either relapsed or are at high risk to relapse.

Eligibility

Min Age: 12 MonthsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether giving nivolumab (an immunotherapy drug) after a partially mismatched bone marrow transplant (from a half-matched family donor) helps the immune system fight back against hard-to-treat solid tumors, including sarcomas, in children and young adults. **You may be eligible if...** - You are between 1 year and 50 years old - You have a confirmed solid tumor with a poor expected outcome - You have already received a bone marrow transplant from a half-matched (haploidentical) donor and recovered from its immediate side effects - You are functional enough to perform basic daily activities (Karnofsky ≥50% or Lansky ≥60 for younger patients) - Your kidney, liver, and blood counts meet the minimum thresholds - You consent to a tumor biopsy **You may NOT be eligible if...** - You have an active graft-versus-host disease (immune attack of the transplant on your body) requiring treatment - You have active or uncontrolled infections - You have severe organ dysfunction - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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