Nivolumab After Bone Marrow Transplant for Sarcoma

This study is testing a drug called Nivolumab after a "half-matched" (haploidentical) bone marrow transplant (BMT) in children and adults with sarcoma. The goal is to see if Nivolumab is safe and if it can help prevent or delay the sarcoma from coming back or getting worse. Researchers also want to understand how Nivolumab affects blood and tumors. You might be able to join if you are between 12 months and 40 years old, have a solid tumor like sarcoma, and have recently had a "half-matched" BMT. The main thing researchers will be looking at is any side effects from Nivolumab over 4 years. The study is currently recruiting 39 participants, but its overall status is unclear.

Study design
This is an interventional study with a planned enrollment of 39 participants. It is testing the drug Nivolumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be measured for 4 years after enrollment.

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NCT03465592

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

Recruiting
PHASE1Ages 12–40InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~39 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Nivolumab

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse events attributed to Nivolumab for patients enrolled in this study
Measured over 4 years
Sarcoma
Solid Tumor, Adult
Solid Tumor, Childhood
4 sites across 3 states
New York2
Florida1
Maryland1
  • Nicolas Llosa, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

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Eligibility criteria

Inclusion

Peripheral absolute neutrophil count (ANC) ≥ 500/mm3
Platelet count ≥ 50,000/mm3 2. Patients with known bone marrow metastatic disease will be eligible for study without the above criteria. They may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions. These patients will not be evaluable for hematologic toxicity.
Age 1 to \<2 years, Male: 0.6 and Female: 0.6
Age 2 to \<6 years, Male: 0.8 and Female: 0.8
Age 6 to \<10 years, Male: 1 and Female:1
Age 10 to \<13 years, Male: 1.2 and Female 1.2
Age 13 to \<16 years, Male: 1.5 and Female 1.4
Age ≥ 16 years, Male: 1.7 and Female 1.4
  • Adverse events attributed to Nivolumab for patients enrolled in this study4 years

    Cumulative adverse events from Nivolumab therapy administered after reduced intensity conditioning (RIC) haploidentical bone marrow transplant (haploBMT) in children and young adults with high risk sarcomas at the time of relapse (part A) or pre-emptively (part B).