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Checkpoint Inhibitor
Atezolizumab + Tiragolumab for Rare Cancers
Phase 2
Recruiting
Led By Naoko Takebe
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial tests whether a combination of two immunotherapies can help shrink tumors in patients with advanced-stage rare solid tumors. Biopsies & blood samples are taken to measure response to the drugs.
Who is the study for?
Adults with advanced rare solid tumors that have progressed after standard therapy or lack a standard treatment. They must be willing to undergo biopsies, not qualify for higher priority trials, and have measurable disease. Key health criteria include stable organ function and controlled HIV or hepatitis if present. Pregnant women are excluded, and participants must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining two immunotherapy drugs, Atezolizumab and Tiragolumab, in shrinking advanced stage rare solid tumors. It includes taking tissue samples before and after treatment to study the immune response against cancer.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system attacking normal cells leading to inflammation in various organs, infusion-related reactions similar to allergic responses during drug administration, fatigue, blood disorders like low counts of different types of blood cells which can increase infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the proportion of active CD8+ T cells infiltrating the tumor
Incidence of adverse events
Pharmacodynamic (PD) response rate
Secondary outcome measures
Objective tumor response rate (ORR)
Progression-free survival (PFS) time
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (atezolizumab, tiragolumab)Experimental Treatment6 Interventions
Patients receive atezolizumab and tiragolumab intravenously (IV) on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO during screening, and CT scans during screening, at the end of cycle 3 and every 2 cycles thereafter. Patients undergo tumor biopsy at baseline, on cycle 3 day 1 and optionally at response or disease progression, and blood sample collection at baseline, on day 1 of every subsequent cycle, and at time of response/disease progression on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tiragolumab
2020
Completed Phase 2
~350
Atezolizumab
2017
Completed Phase 3
~5860
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Echocardiography
2013
Completed Phase 4
~11670
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,426 Total Patients Enrolled
Naoko TakebePrincipal InvestigatorNational Cancer Institute LAO
2 Previous Clinical Trials
95 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My rare solid tumor has not responded to standard treatments or there are none available.My tumor can be safely biopsied.I do not have any severe illnesses that would stop me from following the study's requirements.I have recovered from major side effects of my last cancer immunotherapy.I finished my monoclonal antibody therapy more than 5 weeks ago.I have never received anti-TIGIT therapy.I have not taken any antibiotics in the last 2 weeks.I have active tuberculosis.I have not had a severe infection in the last 4 weeks.My kidney function, measured by creatinine levels or clearance, is within the required range.I am willing to give samples for research.My hepatitis B virus load is undetectable with treatment.I am HIV positive, on treatment, and my viral load is undetectable.I have not had signs of infection in the last 2 weeks.I haven't taken any immune-weakening medications in the last 2 weeks.I am 18 years old or older.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.My doctor does not believe I need immediate treatment for my brain metastases or leptomeningeal disease.I received my flu shot during the flu season.I can take care of myself but might not be able to do heavy physical work.I am on a stable dose of blood thinner medication.My brain cancer has not worsened for over a month after treatment.I had hepatitis C but have been treated and cured.I have another cancer type, but it won't affect this trial's treatment.I have had major surgery before starting the treatment and have not fully recovered.I agree to use birth control during and for 5 months after the study.I have a history of heart issues or have been treated with heart-toxic drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the combination of atezolizumab and tiragolumab officially sanctioned by the FDA?
"Atezolizumab and tiragolumab have received a score of 2 on our safety scale. This is due to the limited clinical data indicating its safeness, with no evidence yet available for efficacy."
Answered by AI
What is the aggregate figure of participants in this trial?
"Indeed, the clinicaltrials.gov website confirms that this research is still open for enrolment. Initially posted on October 8th 2023 and last amended July 13th 2023, it seeks to recruit 15 persons at a single location."
Answered by AI
Are there openings currently available for this experimental research?
"Affirmative. According to clinicaltrials.gov, the research study was initially posted on October 8th 2023 and is still actively recruiting participants. 15 patients need to be enrolled from 1 specific medical centre."
Answered by AI
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