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Immunotherapies in Combination With Stereotactic Body Radiation Radiotherapy in Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC)

NCT06603818 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-02-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Tiragolumab

Tiragolumab is given intravenously (IV) every 3 weeks (21-day cycles) for up to 2 years

BIOLOGICAL

Atezolizumab

Atezolizumab is given intravenously (IV) every 3 weeks (21-day cycles) for up to 2 years

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

SBRT will occur on Days 1, 3, and 5 of Cycle 1 only

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Tim F Greten, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2025-08-15
Completion
2025-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06603818 on ClinicalTrials.gov