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VITAS: Atezolizumab with Chemotherapy for Pediatric Solid Tumors

This study is testing a new combination of medicines for children and young adults (ages 6 months to 30 years) with solid tumors that have returned or not responded to previous treatments. The study uses four drugs: atezolizumab, vincristine, irinotecan, and temozolomide. Researchers want to see if this combination is safe and effective. They will first check for side effects (dose-limiting toxicities) in a small group. If safe, they will then study how well it works in a larger group of patients with rhabdomyosarcoma (a type of cancer that forms in soft tissue). The goal is to see if the tumors shrink or stop growing. This study is currently recruiting up to 23 participants.

Study design
This is a multi-center, non-randomized, open-label study with two groups: a feasibility group of 6 patients to check safety, and an efficacy group of 17 patients with rhabdomyosarcoma to see how well the treatment works.
What's involved
The drugs are given intravenously (into a vein) or by mouth on specific days of a 21-day cycle. You would receive treatment and be monitored for side effects.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track serious side effects for up to 48 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04796012

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

Recruiting
PHASE1Ages 6–30InterventionalTreatment
University of Texas Southwestern Medical Center
~23 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:AtezolizumabVincristineIrinotecanTemozolomide

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Dose-limiting Toxicities (DLTs)
Measured over Beginning of cycle 3, or 30 days after the second cycle has started, whichever is earlier (each cycle is 21 days)
+5 more outcomes measured

Conditions

Solid Tumor
Rhabdomyosarcoma

Explore related trials

RhabdomyosarcomaSolid NeoplasmProgrammed Cell Death 1 Ligand 1

Where it's being run

7 sites across 6 states
Texas2
Illinois1
Massachusetts1
Ohio1
Pennsylvania1
Washington1

Study leadership

  • Arhanti Sadanand, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Arhanti Sadanand, MD
[email protected]
214-645-9122
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

No metastatic or primary disease affecting the brainstem, midbrain, pons, or cerebellum, or within 10 mm of optic nerve
No history of leptomeningeal disease
No history of intracranial or spinal cord hemorrhage
No evidence of progression of neurologic deficit, in the investigator's judgment, within 7 days prior to initiation of study medications. 3. Must have histologically confirmed rhabdomyosarcoma (RMS) for RMS efficacy cohort. 3. Age ≥ 6 months and ≤ 30 years 4. Lansky Performance Status (patients \< 16 years old) or Karnofsky Performance Status (patients ≥ 16 years old) ≥ 50 5. Ability to comply with the study protocol, in the investigator's judgment 6. For RMS efficacy cohort, disease must be measurable as defined by RECIST v1.1.
Absolute neutrophil count ≥ 1.0 x 10\^9 / L (1000/µL) without granulocyte colony-stimulating factor support (≥14 days after the last dose of a long-acting growth factor such as pegfilgrastim, or 7 days after short-acting growth factor)
Platelet count ≥ 75 x 10\^9 / L (75,000/µL) without transfusion in the last 7 days 2. Patients with known bone marrow metastatic disease will be eligible for the study if they meet the following criteria:
Patients with documented liver metastases: AST and ALT ≤ 5 x ULN
Patients with documented liver or bone metastases: ALP ≤ 5 x ULN
Absolute neutrophil count (ANC) ≥ 750/mm\^3
Platelet count ≥ 50,000/mm\^3 (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions)
These patients will not be evaluable for hematologic toxicity. At least 4 of 6 patients in the feasibility cohort must be evaluable for hematologic toxicity. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity. 3. Total bilirubin ≤1.5 x upper limit of normal (ULN) for age (Patients with known Gilbert disease: serum bilirubin ≤ 3 x ULN) 4. AST (SGOT) and ALT (SPGT) ≤ 2.5 x ULN for age 5. Serum albumin ≥ 25 g/L (2.5 g/dL) 6. Creatinine ≤ 1.5 x ULN for age or creatinine clearance (or radioisotope glomerular filtration rate) ≥ 70 mL/min/1.73 m2 7. Left ventricular ejection fraction ≥ 50% or shortening fraction ≥ 30% 8. Hemoglobin ≥ 90 g/L (9 g/dL) 9. Patients may be transfused to meet this criterion. 10. For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN 11. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen 10. Negative HIV and hepatitis B surface antigen (HBsAg) tests at screening 11. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:

Exclusion

Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met at study initiation: (1) Rash must cover less 10% of body surface area, (2) Disease is well controlled at baseline and requires only low-potency topical corticosteroids, (3) No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months 2. Uncontrolled or symptomatic hypercalcemia (ionized calcium \&amp;gt; 1.5 mmol/L, calcium \&amp;gt; 12 mg/dL or corrected serum calcium \&amp;gt; ULN) 3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Patients with indwelling catheters (e.g., PleurX®) are allowed. 4. Uncontrolled tumor-related pain
Patients requiring pain medication must be on a stable regimen at study entry for at least 2 weeks. Intermittent use of as-needed medication is allowed during this period. 5. Clinically significant gastrointestinal disorder that may interfere with absorption of orally administered drugs (at the discretion of the treating physician) 6. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
History of radiation pneumonitis in the radiation field (fibrosis) is permitted. 7. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina 8. History of severe asthma or uncontrolled asthma 9. Dyspnea at rest or requirement for supplemental oxygen 10. Uncontrolled seizures. Patients taking a stable dose of anticonvulsants (for 2 weeks) are permitted, as long as they are not strong inducers or inhibitors of CYP3A4. 11. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications in the opinion of the treating investigator 3. Washout periods from prior therapies:
Subjects must have recovered from all acute prior treatment-related toxicities to grade 1 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism). 2. Non-myelosuppressive cancer therapy, such as kinase inhibitors, within 7 days prior to study treatment. 3. Treatment with monoclonal antibodies with long half-lives, within 3 half-lives prior to study treatment. 4. Treatment with targeted cellular therapies within 28 days prior to starting study treatment. 5. Major surgical procedure, other than for diagnosis, within 30 days prior to initiation of study treatment, or anticipation of the need for a major surgical procedure during the first four cycles of the study.
Biopsy tissue collection or placement of a vascular access device is permitted if the site has healed prior to initiation of study medications.
For patients with CNS disease, no neurosurgical resection, brain biopsy, or stereotactic/whole-brain radiation within 30 days prior to Cycle 1, Day 1 6. Treatment with a live, attenuated vaccine within 30 days prior to initiation of study treatment, or anticipation of the need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab 7. Treatment with investigational therapy within 21 days prior to initiation of study treatment or concurrent participation with another investigational agent 8. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment 9. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-agents) within 2 weeks prior to initiation of study treatment, or anticipation of the need for systemic immunosuppressive medication during study treatment, with the following exceptions:
Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.
Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
Patients with CNS disease can be receiving concurrent treatment with corticosteroids with approval from the Principal Investigator. Patients must be receiving a stable or decreasing dose for ≥ 5 days prior to the baseline MRI scan and at the time of drug initiation. The Principal Investigator should be informed when steroid doses are increased because of declining patient status. 10. Use of strong CYP3A4 inhibitors or inducers or strong UGT1A1 inhibitors within 12 days of Cycle 1, Day 1. 11. Treatment with high-dose chemotherapy and hematopoietic stem-cell rescue within 3 months prior to initiation of study drug 12. Treatment with herbal cancer therapy within 1 week prior to initiation of study medications. 13. Treatment with a long-acting hematopoietic growth factor (such as pegfilgrastim) within 2 weeks prior to initiation of study medications, or a short-acting hematopoietic growth factor (such as G-CSF) within 1 week prior to initiation of study medications. 4. Prior treatments:

What this trial measures

  • Number of participants with Dose-limiting Toxicities (DLTs)Beginning of cycle 3, or 30 days after the second cycle has started, whichever is earlier (each cycle is 21 days)

    DLT is defined as any event that is possibly, probably, or definitely attributable to the treatment regimen and exceeds the protocol defined threshold for severity

  • Number of participants with Acute Adverse Events (AEs)42 days post treatment.

    AE is defined as any untoward or unfavorable medical occurrence in a human research study participant, including any abnormal sign, symptom, clinical event, or disease, temporally associated with the subject's participation in the research, whether or not it is considered related to the subject's participation in the research. AEs will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Adverse events not specifically defined in the NCI CTCAE will be scored on the Adverse Event log according to the general guidelines provided by the NCI CTCAE. Acute AEs are events occurring in the time period from the signing of the informed consent, through 42 days post treatment.

  • Number of participants with Serious Adverse Events (SAEs)48 months

    SAEs are those events, occurring at any dose, which meets any of the following criteria: 1) results in death, 2) is life-threatening, 3) results in inpatient hospitalization or prolongation of existing hospitalization, 4) results in a persistent or significant disability/incapacity, 5) results in a congenital anomly/birth defect in a neonate/infant born to a mother exposed to the IMP; or 6) based upon appropriate medical judgement, may jeopardize the subject's health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. SAE determination does not require the event to be related to the research. SAEs will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Serious adverse events not specifically defined in the NCI CTCAE will be scored on the Adverse Event log according to the general guidelines provided by the NCI CTCAE.

  • Objective response rate (ORR)Up to 18 weeks post treatment

    ORR is the percentage of participants whose confirmed best overall response was either a partial response (PR) or a complete response (CR) based upon independent review and per RECIST v1.1, modified INRC, or RANO criteria as appropriate.

  • Objective response rate (ORR)Week 18 up to 24 months post treatment

    ORR is the percentage of participants whose confirmed best overall response was either a partial response (PR) or a complete response (CR) based upon independent review and per RECIST v1.1, modified INRC, or RANO criteria as appropriate.

  • Objective response rate (ORR)Month 24 up to end of study (approximately 48 months)

    ORR is the percentage of participants whose confirmed best overall response was either a partial response (PR) or a complete response (CR) based upon independent review and per RECIST v1.1, modified INRC, or RANO criteria as appropriate.