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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Mar 2024

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At a glance

  • Drugs Nivolumab (Primary)
  • Indications Sarcoma; Solid tumours
  • Focus Adverse reactions
  • Most Recent Events

    • 08 Jun 2021 Planned End Date changed from 1 Mar 2026 to 1 Mar 2029.
    • 08 Jun 2021 Planned primary completion date changed from 1 Jan 2025 to 1 Jan 2027.
    • 25 Sep 2020 Protocol amended to treatment to include dose for adult: 240 mg IV over 30 minutes every 2 weeks OR 480 mg IV over 30 minutes every 4 weeks Children and Adolescents weighing less than 40 kg: 3 mg/kg IV over 30 minutes every 2 weeks, eligibility criteria amended to include patients upto age 50.
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