Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children &… (NCT03465592) | Clinical Trial Compass
RecruitingPhase 1/2
Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma
United States39 participantsStarted 2018-05-01
Plain-language 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.
Who can participate
Age range12 Months – 40 Years
SexALL
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Inclusion criteria
✓. Patients must be ≥ 12 months and ≤ 50 years of age at the time of study enrollment.
✓. Patients with histologically confirmed solid tumors with an estimated poor long term survival.
✓. Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 60 for patients ≤16 years of age.
✓. Patients must be post RIC haploidentical BMT.
✓. Patients must have fully recovered from the acute toxic effects of prior BMT.
✓. Concomitant radiation therapy can be administered in the setting of this trial.
✓. Subjects must consent to allow for a baseline tumor biopsy. If a biopsy is not feasible, then archival tumor material must be made available. Tumor biopsies to be taken (if a subject's tumor is thought to be reasonably safe and easy to biopsy) at baseline (any time prior to the first dose after eligibility is met) and at Cycle 2 (4-6 cores per time point) or when lesions are visualized on physical examination or imaging studies in the case of no identifiable masses at cycle 2. Additional optional biopsies may be obtained later in the course of study treatment. The proposed investigation is considered a non-significant risk (NSR). A significant risk procedure is generally considered to be one for which the procedure-associated absolute risk of mortality or major morbidity, in the patient's clinical setting and at the institution completing the procedure, is 2% or higher. Diagnostic Tissue Samples Tissue, fluid, or blood may be collected from standard of care procedures used to treat or diagnose immune related toxicities/GVHD.
What they're measuring
1
Adverse events attributed to Nivolumab for patients enrolled in this study
Timeframe: 4 years
Trial details
NCT IDNCT03465592
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
✕. GVHD: any history of Stage 4 skin GVHD or Stage 3 gut/liver GVHD (a.k.a. overall Grade III/IV GVHD) or any severe chronic GVHD. Any person with ≤ Grade II GVHD must be off systemic immunosuppressive therapy for at least 2 weeks prior to receiving Nivolumab therapy.
✕. Inhaled or topical steroids and adrenal replacement steroid doses are permitted in the absence of active auto- or allo-immune disease
✕. BMT-related toxicities: patients who developed idiopathic pneumonia syndrome (IPS) or veno-occlusive hepatic disease (VOD) must be off systemic immunosuppression and/or defibrotide for at least 14 days to be eligible.
✕. Infection: Patients who have an uncontrolled infection.
✕. Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
✕. Has active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.