Nivolumab in Relapsed Pediatric Solid Tumors

Sponsor
Hadassah Medical Organization
Study ID
NCT02901145
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Antibodies, Neoplasm

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab,low dose cyclophosphamide — DRUG
    treatment with IV Nivolumab 3mg/kg every 2 weeks . after a month-addition of low dose cyclophosphamide at a starting dose of 50 mg/kg/day x7 days every 14 days with dose adaptation based on level of Tregulatory cells on follow up immunophenotype.

Study Details

patients with progressive/relapsed solid tumors who failed first line therapy , will be treated biweekly with the anti PD1- Nivolumab. at least one month after treatment initiation low dose cyclophosphamide will be started . patients on trial will submit tissue and blood tests for whole exome an immune genomic signature. patients will also undergo repeated immunophenotype as part of follow up.

Key Dates

Start date
Nov 30, 2016
Status verified
Sep 2016
Primary completion
Nov 30, 2019
Completion
Mar 31, 2020

Study Design

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

Arms

  • Experimental: progressive/relapsed solid tumors
    patient with progressive/relapsed solid tumors who failed first line therapy

Primary Outcome Measure

Event free survival [ Time Frame: 6 months ]

Central Contacts