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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 belowSelect...
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.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreTrial 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
~1160
Positron Emission Tomography
2008
Completed Phase 2
~2210
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Atezolizumab
2017
Completed Phase 3
~5860
Tiragolumab
2020
Completed Phase 2
~460
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Chordoma include surgery, radiation, and increasingly, immunotherapy using monoclonal antibodies like Tiragolumab and Atezolizumab. These monoclonal antibodies work by targeting specific proteins on cancer cells or immune cells, thereby enhancing the immune system's ability to recognize and destroy cancer cells.
This mechanism is crucial for Chordoma patients because the tumor's location and resistance to conventional treatments make it challenging to treat effectively. By boosting the immune response, these therapies offer a promising alternative that could lead to better outcomes for patients with this rare and difficult-to-treat cancer.
Phase 2 study of pembrolizumab in patients with recurrent and residual high-grade meningiomas.Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.
Phase 2 study of pembrolizumab in patients with recurrent and residual high-grade meningiomas.Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,728 Previous Clinical Trials
40,965,917 Total Patients Enrolled
12 Trials studying Chordoma
2,158 Patients Enrolled for Chordoma
Mary F Wedekind MalonePrincipal InvestigatorPediatric Early Phase Clinical Trial Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor lacks SMARCB1 (INI1) or SMARCA4, confirmed by a certified lab test.I have recovered from side effects of previous cancer treatments.I haven't had certain medications or live vaccines in the last 30 days.My cancer can be measured or seen on tests.I do not have any active autoimmune diseases, infections like TB, hepatitis B or C, recent EBV, HIV, serious heart issues, recent major surgeries, specific lung conditions, uncontrolled effusions or infections, prior organ transplants, and can follow safety monitoring.My kidney, liver, and blood tests meet the required levels.Your blood count must be within certain levels.My disease has returned, is resistant, or is newly diagnosed with no cure.I have never received TIGIT targeting therapy.My nerve-related side effects from previous treatments are mild.Your calcium level must be low or normal.I can take care of myself but may not be able to do heavy physical work.I am at least 1 year old. If enrolling in part A, I am under 18.I have seizures but they are well controlled with medication.I am not currently taking steroid medications and it's been over 14 days since my last dose, with certain exceptions.You are allergic to certain ingredients.I am currently taking medications like steroids, cancer drugs, or drugs that affect my immune system.I have had a bone marrow or stem cell transplant from a donor.I have brain metastases that haven't been treated, with some exceptions.
Research Study Groups:
This trial has the following groups:- Group 1: Part A (atezolizumab, tiragolumab)
- Group 2: Arm B (atezolizumab, tiragolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chordoma Patient Testimony for trial: Trial Name: NCT05286801 — Phase 1 & 2
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