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OncoMatch/Clinical Trials/NCT03465592

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

Is NCT03465592 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Nivolumab for sarcoma.

Phase 1/2RecruitingSidney Kimmel Comprehensive Cancer Center at Johns HopkinsNCT03465592Data as of May 2026

Treatment: Nivolumab — 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.

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Extracted eligibility criteria

Cancer type

Sarcoma

Tumor Agnostic

Prior therapy

Must have received: stem cell transplant — post RIC haploidentical BMT

Patients must be post RIC haploidentical BMT.

Lab requirements

Blood counts

For patients without known bone marrow involvement: ANC ≥ 500/mm3, Platelet count ≥ 50,000/mm3. Patients with known bone marrow metastatic disease are eligible without these criteria.

Kidney function

Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 or age/gender-based serum creatinine thresholds

Liver function

Bilirubin (sum of conjugated + unconjugated) ≤1.5 x ULN for age; SGPT (ALT) ≤110 U/L (ULN for SGPT is 45 U/L)

Organ Function Requirements: I. Adequate Hematologic Parameters: For patients with solid tumors without known bone marrow involvement: Peripheral absolute neutrophil count (ANC) ≥ 500/mm3; Platelet count ≥ 50,000/mm3. Patients with known bone marrow metastatic disease will be eligible for study without the above criteria. II. Adequate Renal Function Defined as: Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 or a serum creatinine based on age/gender. III. Adequate Liver Function Defined as: Bilirubin ≤1.5 x ULN for age; SGPT (ALT) ≤110 U/L (ULN for SGPT is 45 U/L).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Johns Hopkins All Children's Hospital · St. Petersburg, Florida
  • Johns Hopkins Hospital · Baltimore, Maryland
  • Albert Einstein College of Medicine, Children's Hospital at Montefiore · The Bronx, New York
  • New York Medical Center/ Maria Fareri Children's Hospital · Valhalla, New York

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