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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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.
Description
High risk, recurrent, or refractory solid tumors in pediatric, adolescent and young adult (AYA) patients have an extremely poor prognosis despite current intensive treatment regimens. Johns Hopkins piloted an allogeneic bone marrow transplant (alloBMT) platform using a reduced intensity conditioning (RIC) and partially HLA-mismatched (haploidentical) related donors for this population of pediatric and AYA solid tumor patients.With this strategy, investigators demonstrated that RIC haploBMT with post-transplant cyclophosphamide (PTCy) is feasible and has acceptable toxicities in patients with i…
Eligibility
- Age range
- 1–40 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must be ≥ 12 months and ≤ 50 years of age at the time of study enrollment. 2. Patients with histologically confirmed solid tumors with an estimated poor long term survival. 3. Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 60 for patients ≤16 years of age. 4. Patients must be post RIC haploidentical BMT. 5. Patients must have fully recovered from the acute toxic effects of prior BMT. 6. Concomitant radiation therapy can be administered in the setting of this trial. 7. Subjects must consent to allow for a baseline tumor biopsy. I…
Interventions
- DrugNivolumab
Administered IV
Locations (4)
- Johns Hopkins All Children's HospitalSt. Petersburg, Florida
- Johns Hopkins HospitalBaltimore, Maryland
- Albert Einstein College of Medicine, Children's Hospital at MontefioreThe Bronx, New York
- New York Medical Center/ Maria Fareri Children's HospitalValhalla, New York