VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors
1 other identifier
interventional
23
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2023
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 12, 2021
CompletedStudy Start
First participant enrolled
April 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
June 2, 2026
May 1, 2026
3.7 years
February 22, 2021
May 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number of participants with Dose-limiting Toxicities (DLTs)
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
Beginning of cycle 3, or 30 days after the second cycle has started, whichever is earlier (each cycle is 21 days)
Number of participants with Acute Adverse Events (AEs)
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.
42 days post treatment.
Number of participants with Serious Adverse Events (SAEs)
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.
48 months
Objective response rate (ORR)
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.
Up to 18 weeks post treatment
Objective response rate (ORR)
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.
Week 18 up to 24 months post treatment
Objective response rate (ORR)
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.
Month 24 up to end of study (approximately 48 months)
Secondary Outcomes (9)
Duration of response
Up to 18 weeks post treatment
Duration of response
Week 18 up to 24 months post treatment
Duration of response
Month 24 up to end of study (approximately 48 months)
Progression-free survival (PFS)
Up to 18 weeks post treatment
Progression-free survival (PFS)
Week 18 up to 24 months post treatment
- +4 more secondary outcomes
Study Arms (2)
Feasibility Cohort: Patients with relapsed or refractory solid tumors
EXPERIMENTALSix (6) participants with relapsed or refractory solid tumor will be enrolled. Atezolizumab will be administered in combination with vincristine, irinotecan, and temozolomide for up to 2 years or until the participant experiences disease progression or an unacceptable toxicity.
Rhabdomyosarcoma (RMS) Cohort: Patients with rhabdomyosarcoma
EXPERIMENTALSeventeen (17) participants with RMS, including the six participants from the Feasibility Cohort, will be enrolled. At least 8 of the RMS participants must have a tumor that expresses the protein PD-L1. Atezolizumab will be administered in combination with vincristine, irinotecan, and temozolomide for up to 2 years or until the participant experiences disease progression or an unacceptable toxicity.
Interventions
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
Feasibility and RMS Cohorts: Administered at 15 mg/kg (max 1,200 mg) IV on Day 1 of each 21-day cycle
Feasibility and RMS Cohorts: Administered at 1.5 mg/m\^2 (max 2 mg) IV on Day 1 of each 21-day cycle
Feasibility and RMS Cohorts: Administered at 50 mg/m2 IV on Days 1-5 of each 21-day cycle
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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
- For RMS efficacy cohort, disease must be measurable as defined by RECIST v1.1.
- For the feasibility cohort, disease must be evaluable, but patients enrolled in the feasibility cohort will be prospectively assessed for measurable disease, RMS patients will also be included in the RMS efficacy cohort.
- Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.
- +35 more criteria
You may not qualify if:
- 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:
- 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
- Uncontrolled or symptomatic hypercalcemia (ionized calcium \&gt; 1.5 mmol/L, calcium \&gt; 12 mg/dL or corrected serum calcium \&gt; ULN)
- 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.
- 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.
- Clinically significant gastrointestinal disorder that may interfere with absorption of orally administered drugs (at the discretion of the treating physician)
- 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
- +39 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Seattle Children's
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arhanti Sadanand, MD
University of Texas Southwestern Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
February 22, 2021
First Posted
March 12, 2021
Study Start
April 18, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
June 2, 2026
Record last verified: 2026-05