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Checkpoint Inhibitor

Tiragolumab + Atezolizumab for Solid Tumors

Phase 1 & 2
Recruiting
Led By Mary F Wedekind Malone
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have SMARCB1 (INI1) or SMARCA4 deficient tumors verified through institutional immunohistochemistry (IHC) or molecular confirmation of a pathologic tumor bi-allelic SMARCB1 (INI1) or SMARCA4 loss or mutation from a Clinical Laboratory Improvement Act (CLIA) certified lab with specific disease histologies
Patients must have either measurable or evaluable disease for Part A and either measurable disease per RECIST v1.1 for non-CNS tumors or CNS response criteria for CNS tumors for Part B
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing the combination of two immunotherapy drugs, tiragolumab and atezolizumab, to see if they are effective in treating SMARCB1 or SMARCA4 deficient tumors.

Who is the study for?
This trial is for children and adults with specific aggressive cancers that lack SMARCB1 or SMARCA4 genes. Participants must have recovered from previous cancer treatments, not received certain therapies recently, and have measurable disease. It's open to those aged 12 months and older (under 18 for part A; no upper age limit for part B), who haven't had TIGIT therapy, are not on systemic steroids, and meet blood count and organ function criteria.Check my eligibility
What is being tested?
The trial tests tiragolumab plus atezolizumab in patients with relapsed or refractory tumors lacking the SMARCB1/SMARCA4 genes. This study aims to see if these immunotherapy drugs can help the immune system fight cancer more effectively by preventing tumor growth.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation of organs, infusion-related reactions like fever or chills, fatigue, digestive issues including nausea or diarrhea, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor lacks SMARCB1 (INI1) or SMARCA4, confirmed by a certified lab test.
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My cancer can be measured or seen on tests.
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My kidney, liver, and blood tests meet the required levels.
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My disease has returned, is resistant, or is newly diagnosed with no cure.
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I have never received TIGIT targeting therapy.
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I can take care of myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of cycle 1 dose limiting toxicities of the combination of tiragolumab and atezolizumab in patients < 12 years
Frequency of cycle 1 dose limiting toxicities of tiragolumab as monotherapy in pediatric patients
Frequency of objective response for the combination of tiragolumab and atezolizumab
Secondary outcome measures
Duration of response of the combination therapy for tiragolumab and atezolizumab
Overall survival (OS) of the combination therapy for tiragolumab and atezolizumab
Combined Modality Therapy
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part A (atezolizumab, tiragolumab)Experimental Treatment8 Interventions
Patients receive tiragolumab IV over 30-90 minutes on day 1 of each cycle and atezolizumab IV over 30-60 minutes on day 1 of each cycle starting in cycle 2. Treatment repeats every 21 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients undergo standard imaging scans including x-rays, CT, MRI, and/or FDG PET-CT, throughout the trial. Patients also undergo blood sample collection on study.
Group II: Arm B (atezolizumab, tiragolumab)Experimental Treatment8 Interventions
Patients receive atezolizumab IV over 30-60 minutes on day 1 and tiragolumab IV over 30-90 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients also undergo standard imaging scans including x-rays, CT, MRI, and/or FDG PET-CT throughout the trial. Patients also undergo blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Atezolizumab
2017
Completed Phase 3
~5860
Tiragolumab
2020
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,768 Total Patients Enrolled
Mary F Wedekind MalonePrincipal InvestigatorPediatric Early Phase Clinical Trial Network

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05286801 — Phase 1 & 2
Epithelioid Sarcoma Research Study Groups: Part A (atezolizumab, tiragolumab), Arm B (atezolizumab, tiragolumab)
Epithelioid Sarcoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05286801 — Phase 1 & 2
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05286801 — Phase 1 & 2
Epithelioid Sarcoma Patient Testimony for trial: Trial Name: NCT05286801 — Phase 1 & 2

Frequently Asked Questions

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

Are people still being signed up to participate in this experiment?

"The trial is currently looking for candidates, with the original posting date being September 9th, 2020. The last edit was on November 11th, 2020 and the target number of patients is 86 spread out over 13 sites."

Answered by AI

What are the investigators of this trial aiming to discover?

"The goal of this clinical trial, which will span a period of up to 5 years, is to assess the frequency of objective response in patients receiving a combination of tiragolumab and atezolizumab. Secondary outcomes include PK data for tiragolumab and atezolizumab, progression-free survival (PFS), and overall survival (OS)."

Answered by AI

At how many different locations can patients participate in this study?

"Children's Hospital of Orange County in Orange, California, Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center in Houston, Texas, Riley Hospital for Children in Indianapolis, Indiana are a few of the 14 locations where this trial is recruiting patients."

Answered by AI

Who else is applying?

What site did they apply to?
UT Southwestern/Simmons Cancer Center-Dallas
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

Do I have to pay for the treatment? How long will my treatment process take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I hope thus clinical trial help me.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Tiragolumab and Atezolizumab for the Treatment of Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors
2022. "Tiragolumab and Atezolizumab for the Treatment of Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05286801.
All > Chordoma
~43 spots leftby Sep 2025
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