Actively Recruiting
VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors
Led by University of Texas Southwestern Medical Center · Updated on 2026-04-16
23
Participants Needed
7
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Relapsed or refractory solid tumor after at least one prior therapy, excluding Hodgkin lymphoma and non-Hodgkin lymphoma
- Patients with CNS malignancy or asymptomatic CNS metastases meeting specific neurologic criteria
- Histologically confirmed rhabdomyosarcoma for the RMS efficacy cohort
- Age between 6 months and 30 years
- Lansky or Karnofsky Performance Status of 50 or higher
- Ability to follow the study protocol
- Measurable disease for RMS efficacy cohort; evaluable disease for feasibility cohort
- Availability of tumor specimen for PD-L1 status determination
- At least 8 of 17 RMS efficacy patients must have PD-L1 positive tumors
- Adequate organ and marrow function based on defined laboratory values
- Negative HIV and hepatitis B surface antigen tests
- Women of childbearing potential must agree to abstain or use effective contraception during and after treatment
- Men not surgically sterile must agree to abstain or use effective contraception during and after treatment
You will not qualify if you...
- Pregnancy, breastfeeding, or intention to become pregnant during treatment or within 5 months after
- Women of childbearing potential must have a negative pregnancy test before treatment
- Active or history of autoimmune disease or immune deficiency, excluding certain controlled conditions
- Uncontrolled hypercalcemia or effusions requiring frequent drainage
- Uncontrolled tumor-related pain or significant gastrointestinal disorders
- History of severe lung conditions or active pneumonitis
- Significant cardiovascular disease within 3 months prior to treatment
- Severe or uncontrolled asthma or seizures
- Any condition or laboratory finding that contraindicates investigational drug use or increases risk
- Recent myelosuppressive chemotherapy, radiotherapy, or certain cancer therapies within defined washout periods
- Treatment with live vaccines, investigational therapies, or systemic immunostimulatory or immunosuppressive agents within specified timeframes
- Use of strong CYP3A4 or UGT1A1 inhibitors near treatment start
- Prior allogeneic stem cell or solid organ transplant
- Prior treatment with CD137 agonists or immune checkpoint inhibitors
- Known ongoing or untreated infections including tuberculosis, hepatitis B or C
- Known allergy or severe hypersensitivity to study medications or components
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
4
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
6
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
7
Seattle Children's
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
A
Arhanti Sadanand, MD
CONTACT
S
Sara Runyan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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