Immunotherapy + Radiation for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byMaria C Monge Bonilla, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Background: Metastatic colorectal cancer (mCRC) is cancer that has spread beyond the colon and rectum. Most people with mCRC die within 5 years. New immune-based treatments are making progress with some types of colon cancer. But these treatments do little for people with a type of cancer that is microsatellite stable (MSS). MSS is a specific cancer biomarker. Better treatments are needed. Objective: To test 2 drugs (tiragolumab and atezolizumab) combined with radiation therapy in people with MSS mCRC. Eligibility: People aged 18 years and older with MSS mCRC. Design: Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and a test of their heart function. They will provide a tissue sample from their tumor; if one is not already available, a new sample will be taken. Their ability to perform normal tasks will be assessed. Tiragolumab and atezolizumab are both administered through a tube attached to a needle inserted into a vein. Participants will receive both drugs on day 1 of 3-week treatment cycles. Each study visit should last about 8 hours. Participants will receive radiation therapy on days 1, 3, and 5 of cycle 1 only. Blood samples and rectal swabs will be collected on day 1 of every cycle. Imaging scans will be repeated every 9 weeks. Additional tumor samples may be taken during treatment. Treatment will continue for up to 2 years. Participants will have a follow-up visit 1 month after treatment ends. Follow-up visits will continue every 3 months for 1 more year.

Research Team

Maria C Monge Bonilla, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

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.

Inclusion Criteria

Women of child-bearing potential (WOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device [IUD], surgical sterilization, abstinence) at the study entry and up to 5 months after the last dose of the study drugs (restriction period)

Participants must be willing to co-enroll in protocol 11-C-0112, Acquisition of Blood and Tumor Tissue Samples from Patients with Gastrointestinal Cancer

My colorectal cancer diagnosis is confirmed by a lab test or biopsy.

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Exclusion Criteria

I haven't taken any antibiotics in the last 2 weeks.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to tiragolumab and atezolizumab or other agents used in a study or known hypersensitivity to Chinese hamster ovary cell products

My calcium levels are not higher than normal and I don't have symptoms of high calcium.

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Treatment Details

Interventions

Atezolizumab (Monoclonal Antibodies)
Stereotactic Body Radiation Therapy (SBRT) (Radiation)
Tiragolumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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