VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors (NCT04796012) | Clinical Trial Compass
RecruitingPhase 1/2
VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors
United States23 participantsStarted 2023-04-18
Plain-language 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.
Who can participate
Age range6 Months – 30 Years
SexALL
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Inclusion criteria
✓. Signed informed consent
✓. Relapsed or refractory solid tumor after at least one prior course of therapy.
✓. Hodgkin lymphoma or non-Hodgkin lymphoma are not permitted.
✓. Patients with CNS malignancy or asymptomatic CNS metastases may be enrolled, provided all of the following criteria are met.
✓. Must have histologically confirmed rhabdomyosarcoma (RMS) for RMS efficacy cohort.
✓. Age ≥ 6 months and ≤ 30 years
✓. Lansky Performance Status (patients \< 16 years old) or Karnofsky Performance Status (patients ≥ 16 years old) ≥ 50
✓. Ability to comply with the study protocol, in the investigator's judgment
Exclusion criteria
✕. Pregnancy or breast-feeding:
✕. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment
✕. Women of childbearing potential must have a negative serum pregnancy test result within 21 days prior to initiation of study treatment.
✕. Medical conditions that are excluded:
✕. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Guillain-Barré syndrome, multiple sclerosis, or Kawasaki syndrome with the following exceptions:
What they're measuring
1
Number of participants with Dose-limiting Toxicities (DLTs)
Timeframe: Beginning of cycle 3, or 30 days after the second cycle has started, whichever is earlier (each cycle is 21 days)
2
Number of participants with Acute Adverse Events (AEs)
Timeframe: 42 days post treatment.
3
Number of participants with Serious Adverse Events (SAEs)
Timeframe: 48 months
4
Objective response rate (ORR)
Timeframe: Up to 18 weeks post treatment
5
Objective response rate (ORR)
Timeframe: Week 18 up to 24 months post treatment
6
Objective response rate (ORR)
Timeframe: Month 24 up to end of study (approximately 48 months)
Trial details
NCT IDNCT04796012
SponsorUniversity of Texas Southwestern Medical Center