Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients

This is a phase I/II study to evaluate the safety of combining intravenous (IV) atezolizumab and bevacizumab every three weeks, with daily oral cyclophosphamide and pharmacokinetic (PK)-guided sorafenib in children and adolescent and young adults (AYA) with relapsed or refractory solid malignancies (Part 1), and then evaluate the response rate of this combination in children, AYA with relapsed or refractory fibrolamellar carcinoma (FLC) and other rare solid malignancies (Part 2). Primary Objectives Part 1 * To establish the safety associated with the administration of the combination of cycl

Trial Details

NCT ID
NCT05468359
Phase
PHASE1 / PHASE2
Sponsor
St. Jude Children's Research Hospital
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • Atezolizumab
  • Sorafenib
  • Bevacizumab
  • Cyclophosphamide
Locations (sample)
  • Germantown, Tennessee, United States|35.08676,-89.81009
  • Memphis, Tennessee, United States|35.14953,-90.04898

Key Eligibility Criteria

  • Age: Patients must be \< 30 years at the time of enrollment on study.
  • Willingness to enroll on the St. Jude Molecular Analysis of Solid Tumors (MAST) study.
  • Part 1: Patients with refractory or recurrent (relapsed) solid tumors accessible by biopsy for which there is no standard therapy are eligible.
  • Part 2: Patients with one of the following diagnoses:

For full eligibility, visit ClinicalTrials.gov.

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