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Monoclonal Antibodies

Atezolizumab + Chemotherapy for Pediatric Solid Cancers

Phase 1 & 2
Recruiting
Led By Matthew Campbell, MD
Research Sponsored by Matthew Campbell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Creatinine ≤ 1.5 x ULN for age or creatinine clearance (or radioisotope glomerular filtration rate) ≥ 70 mL/min/1.73 m2
PD-L1(+) status will be defined as staining on ≥1% of tumor cells or ≥1% of stroma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 24 up to end of study (approximately 48 months)
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat pediatric cancer patients who have relapsed or are unresponsive to other treatments.

Who is the study for?
This trial is for children and young adults aged 6 months to 30 years with relapsed or refractory solid tumors, including rhabdomyosarcoma. Participants must have had at least one prior therapy, meet specific health criteria (like organ function tests), agree to use effective contraception if of childbearing potential, and be able to follow the study protocol.Check my eligibility
What is being tested?
The VITAS trial is testing a combination of drugs: vincristine, irinotecan, temozolomide, and atezolizumab in pediatric patients. It's an open-label Phase I/II study which means everyone gets the treatment and both safety and effectiveness are being measured.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions like fever or chills, fatigue, digestive issues like nausea or diarrhea, blood disorders that can affect cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by creatinine levels or clearance, is within the normal range.
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My cancer shows PD-L1 positive status.
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I am between 6 months and 18 years old.
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I can do most activities but may need help.
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My liver enzymes are within normal limits for my age.
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My cancer can be measured or seen on scans, and it has grown despite previous treatments.
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I can provide a tumor sample and report for PD-L1 testing.
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I have never had bleeding in my brain or spinal cord.
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My cancer has not spread to specific areas of my brain or close to my optic nerve.
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I have never had cancer spread to the lining of my brain and spinal cord.
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My recent tests show my organs and bone marrow are functioning well.
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I have a solid tumor that didn't respond to treatment, but not lymphoma, and no severe brain issues.
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My solid tumor cancer came back or didn't respond after my first treatment.
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I am between 6 months and 30 years old.
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I can provide a sample of my tumor for PD-L1 testing.
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My cancer is confirmed to be rhabdomyosarcoma.
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I can provide a tumor sample for PD-L1 testing.
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My tumor is PD-L1 positive.
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I do not have Hodgkin or non-Hodgkin lymphoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 24 up to end of study (approximately 48 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 up to end of study (approximately 48 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Acute Adverse Events (AEs)
Number of participants with Dose-limiting Toxicities (DLTs)
Number of participants with Serious Adverse Events (SAEs)
+1 more
Secondary outcome measures
Duration of response
Overall survival (OS)
Progression-free survival (PFS)

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Rhabdomyosarcoma (RMS) Cohort: Patients with rhabdomyosarcomaExperimental Treatment4 Interventions
Seventeen (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.
Group II: Feasibility Cohort: Patients with relapsed or refractory solid tumorsExperimental Treatment4 Interventions
Six (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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Vincristine
2003
Completed Phase 4
~2910
Irinotecan
2017
Completed Phase 4
~2680
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Matthew CampbellLead Sponsor
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,776 Total Patients Enrolled
Matthew Campbell, MDPrincipal InvestigatorUT Southwestern Medical Center
2 Previous Clinical Trials
1 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04796012 — Phase 1 & 2
Solid Tumors Research Study Groups: Rhabdomyosarcoma (RMS) Cohort: Patients with rhabdomyosarcoma, Feasibility Cohort: Patients with relapsed or refractory solid tumors
Solid Tumors Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04796012 — Phase 1 & 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04796012 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research open to senior citizens?

"This medical trial is recruiting participants who are between 6 and 30 years of age."

Answered by AI

What is the current enrollment size of this clinical trial?

"This research is no longer accepting participants. Originally posted on January 1st 2023, the trial's last update was August 30th 2022. If you are looking for alternative studies, there are currently 2585 cancer-related trials recruiting and 997 utilizing Atezolizumab as a treatment option actively seeking people to participate."

Answered by AI

Has there been past research on Atezolizumab's efficacy?

"Presently, there are 997 Atezolizumab clinical trials in progress with 227 of those being Phase 3. Most studies for this medication are conducted at Woolloongabba, Queensland yet 44346 other sites worldwide have launched similar research projects."

Answered by AI

What medical conditions does Atezolizumab typically address?

"Atezolizumab is a viable treatment option for gestational trophoblastic disease, neoplasms and chronic lymphocytic leukaemia (CLL)."

Answered by AI

Has the FDA greenlighted Atezolizumab for therapeutic use?

"The safety profile of Atezolizumab is estimated to be a 2, as this trial is currently in its second phase and there are indications that it may be safe, yet no evidence has been presented regarding efficacy."

Answered by AI

Could I be eligible to participate in this trial?

"Successful applicants for this medical trial must have cancer, be aged 6 to 30 years old and join a cohort of no more than 30 individuals."

Answered by AI

Are there any opportunities remaining for people to join this clinical investigation?

"Clinicaltrials.gov confirms that, as of August 30th 2022, this medical research project is no longer recruiting participants. Although the trial in question has ceased recruitment activities, there are 3,582 other studies currently enrolling individuals to participate."

Answered by AI
~9 spots leftby Jan 2025