Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma
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|ClinicalTrials.gov Identifier: NCT03465592|
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Solid Tumor, Adult Solid Tumor, Childhood||Drug: Nivolumab||Phase 1 Phase 2|
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 incurable pediatric and AYA solid tumors; thus, this approach serves as a platform for post-transplant strategies to prevent relapse and optimize progression free survival. In this trial, the central hypothesis is that the efficacy of alloBMT for high risk solid tumors can be improved by developing methods to augment donor T cell responses against antigens selectively or uniquely expressed by tumor tissue.
Investigators aim to demonstrated that Programmed death-ligand 1 (PD-1) blockade with nivolumab will be safe and well tolerated after RIC haplo BMT, initially in a relapsed population (Part A) and ultimately when given pre-emptively (Part B).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Nivolumab will be infused intravenously (IV, in a vein) over 60 minutes every 14 days for a maximum of 24 doses (12 cycles). A cycle is considered 28 days. Participants may continue to receive Nivolumab unless they develop serious side effects or the tumor worsens.
There are two parts to this study. The first part, Part A, is for patients who have relapsed or have progressive disease after their BMT. Part A will enroll approximately 3-9 patients. The second part, Part B, is for patients who have not yet relapsed or progressed after BMT. Part A will be completed to prove that administering the experimental drug after BMT is safe and part B will begin once part A is completed
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
Nivolumab of 3 mg/kg IV will be infused over 60 minutes every 14 days, for a maximum of 24 cycles. A cycle will be considered 28 days. Participants may continue to receive Nivolumab unless they develop serious side effects or the tumor worsens.
- Adverse events attributed to Nivolumab for patients enrolled in this study [ Time Frame: 4 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).
- Overall survival [ Time Frame: 4 years ]Overall survival for patients enrolled in this study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465592
|Contact: Megan Petrycki, RNemail@example.com|
|Contact: Tammy Scott, RNfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Nicolas Llosa, MD 410-502-4997 email@example.com|
|Contact: Megan Petrycki, RN 410-955-0432 firstname.lastname@example.org|
|Principal Investigator: Nicolas Llosa, MD|
|United States, New York|
|Albert Einstein College of Medicine, Children's Hospital at Montefiore||Not yet recruiting|
|Bronx, New York, United States, 10467|
|Contact: David Loeb, MD 718-839-7497 email@example.com|
|Principal Investigator: David Loeb, MD|
|New York Medical Center/ Maria Fareri Children's Hospital||Not yet recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Allyson Flower, MD 914-594-2131 Allyson_Flower@nymc.edu|
|Principal Investigator: Allyson Flower, MD|
|Sub-Investigator: Mitchell Cario, MD|
|Principal Investigator:||Nicolas Llosa, MD||Johns Hopkins University|