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

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03465592
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Sarcoma
  • Solid Tumor, Adult
  • Solid Tumor, Childhood

Eligibility Criteria

Sex
ALL
Age
12 Months - 40 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 1, 2018
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Adults: 240 mg IV over 30 minutes every 2 weeks OR 480 mg IV over 30 minutes every 4 weeks. Children and Adolescents weighing 40 kg or more: 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.A maximum of 24 cycles will be given on study.

Primary Outcome Measure

Adverse events attributed to Nivolumab for patients enrolled in this study [ Time Frame: 4 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-
Johns Hopkins HospitalBaltimoreMaryland21287
Nicolas Llosa, MD
[email protected]
410-502-4997
Megan Petrycki, RN
[email protected]
410-955-0432
Nicolas Llosa, MD (PRINCIPAL_INVESTIGATOR)
Albert Einstein College of Medicine, Children's Hospital at MontefioreThe BronxNew York10467
David Loeb, MD
[email protected]
718-839-7497
David Loeb, MD (PRINCIPAL_INVESTIGATOR)
New York Medical Center/ Maria Fareri Children's HospitalValhallaNew York10595
Aliza Gardenswartz, MD
[email protected]
914-594-2130
Aliza Gardenswartz, MD (PRINCIPAL_INVESTIGATOR)
Mitchell Cario, MD (SUB_INVESTIGATOR)

Find similar trials in St. Petersburg, FL

By research site
Johns Hopkins All Children's Hospital· St. Petersburg, FLJohns Hopkins Hospital· Baltimore, MDAlbert Einstein College of Medicine, Children's Hospital at Montefiore· The Bronx, NYNew York Medical Center/ Maria Fareri Children's Hospital· Valhalla, NY

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