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Monoclonal Antibodies

Immunotherapy + Radiation for Colorectal Cancer

Phase 2
Waitlist Available
Led By Maria C Monge Bonilla, M.D.
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
Evidence of metastatic involvement
History of microsatellite stable (MSS) status
Must not have
History of central nervous system (CNS) metastasis or leptomeningeal disease
Major surgery within 4 weeks prior to starting the study therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of therapy through cycle 1 day 21
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to test the effectiveness of two drugs, tiragolumab and atezolizumab, combined with radiation therapy in treating metastatic colorectal cancer that is microsatellite stable

Who is the study for?
This trial is for adults with metastatic colorectal cancer that's microsatellite stable (MSS). Participants must be able to perform normal tasks and provide a tissue sample from their tumor. They will undergo various tests, including blood work, imaging scans, heart function tests, and an assessment of daily activity levels.
What is being tested?
The study is testing the combination of two immunotherapy drugs—tiragolumab and atezolizumab—with Stereotactic Body Radiation Therapy (SBRT) in treating MSS mCRC. Patients receive both drugs via IV on day 1 of each 3-week cycle plus radiation therapy on days 1, 3, and 5 of the first cycle.
What are the potential side effects?
Potential side effects may include reactions related to immune response such as inflammation in organs or infusion-related reactions. Fatigue, digestive issues due to radiation or immunotherapy drugs are also possible. Blood samples are taken regularly to monitor any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread to other parts of my body.
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My cancer is microsatellite stable (MSS).
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My colorectal cancer diagnosis is confirmed by a lab test or biopsy.
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My cancer has worsened after at least 2 standard treatments.
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I am 18 years old or older.
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My weight is over 35 kg.
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I am fully active or can carry out light work.
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I have at least 2 cancer lesions, with one suitable for targeted radiation.
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My blood and organ functions meet the required levels for the trial.
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I have hepatitis B antibodies but my HBV DNA test is negative and I'm not on HBV treatment.
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I have hepatitis C antibodies but my virus test is negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer spread to my brain or spinal cord.
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I have not had major surgery in the last 4 weeks.
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My calcium levels are not higher than normal and I don't have symptoms of high calcium.
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I have not had a severe infection in the last 4 weeks.
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I haven't had major heart problems or strokes in the last 3 months.
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My condition can potentially be cured with surgery.
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I haven't had chemotherapy, radiation, or biologic therapy in the last 3 weeks.
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I have not been treated with TIGIT or other immunotherapies before.
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I have had a previous transplant of stem cells or an organ.
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I do not need frequent procedures to remove excess fluid from my body.
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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.
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I have active tuberculosis.
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I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of therapy through cycle 1 day 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and start of therapy through cycle 1 day 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Confirm the recommended phase II dose (RP2D) of the combination therapy
Determine the proportion of participants without progression after 9 weeks of the combination therapy
Secondary study objectives
Best overall response (Partial Response + Complete Response) according to RECIST v1.1
Overall Survival
Progression Free Survival
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment3 Interventions
Atezolizumab and tiragolumab IV every 3 weeks cycle plus SBRT on Days 1, 3, and 5 of Cycle 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tiragolumab
2019
Completed Phase 3
~1390
Atezolizumab
2016
Completed Phase 3
~5860
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~950

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,907 Previous Clinical Trials
41,012,108 Total Patients Enrolled
Maria C Monge Bonilla, M.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
60 Total Patients Enrolled
~24 spots leftby Dec 2026
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