NCT04796012

VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors

VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors: An Open-label, Phase II, Single-arm, Multi-center Trial

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 6 Months – 30 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multi-center, non-randomized, open-label Phase I/II study evaluating the feasibility and efficacy of vincristine, irinotecan, temozolomide, and atezolizumab in children with relapsed/refractory solid tumors.

Detailed description

In this study, we will test the combination of atezolizumab with chemotherapy for relapsed solid tumors in childhood. The combination of vincristine, irinotecan, temozolomide, and atezolizumab has not been tested. Thus, the trial will have two sequential cohorts: (1) a feasibility cohort, and (2) a rhabdomyosarcoma (RMS) efficacy cohort. In the first cohort, we will determine the feasibility of administering vincristine, irinotecan, temozolomide, and atezolizumab simultaneously in children with relapsed or refractory solid tumors, regardless of histology or PD-L1 status. We will accrue 6 patients and will determine that the therapy is feasible if no more than 2 patients develop a dose-limiting toxicity. Provided that we meet our primary safety endpoint in the feasibility cohort, we will next accrue patients in the RMS efficacy cohort. We will accrue 17 patients in the RMS efficacy cohort. Patients in the feasibility cohort with RMS will be included in this number. We will determine the objective response rate, duration of response, and progression-free survival for all children with relapsed or refractory solid tumors treated with vincristine, irinotecan, temozolomide, and atezolizumab.

Conditions

• Solid Tumor
• Rhabdomyosarcoma

Interventions

Type	Name	Description
DRUG	Atezolizumab	Feasibility and RMS Cohorts: Administered at 15 mg/kg (max 1,200 mg) IV on Day 1 of each 21-day cycle
DRUG	Vincristine	Feasibility and RMS Cohorts: Administered at 1.5 mg/m\^2 (max 2 mg) IV on Day 1 of each 21-day cycle
DRUG	Irinotecan	Feasibility and RMS Cohorts: Administered at 50 mg/m2 IV on Days 1-5 of each 21-day cycle
DRUG	Temozolomide	Feasibility and RMS Cohorts: Administered at 100 mg/m\^2 (max 200 mg) IV or PO 1 hour before irinotecan injection on Days 1-5 if each 21-day cycle

Timeline

• Start date: 2023-04-18
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2021-03-12
• Last updated: 2026-04-16

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study