Trials / Active Not Recruiting

Active Not RecruitingNCT06784947

Trial of Atezolizumab, Bevacizumab, and Tiragolumab in Patients With Microsatellite Stable, Metastatic Colorectal Cancer

A Phase II Trial of Tiragolumab in Combination With Atezolizumab and Bevacizumab in Patients With Previously Treated, Microsatellite Stable, Metastatic Colorectal Adenocarcinoma

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 13 (actual)

Sponsor: University of Colorado, Denver · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The goal of this study is to learn if a new combination treatment is effective for patients with microsatellite stable, advanced colorectal cancer. The study treatment combines 3 drugs: atezolizumab, bevacizumab, and tiragolumab. The main questions the study aims to answer are: 1. Does the study treatment effectively treat colorectal cancer? 2. Is the study treatment safe for patients with colorectal cancer? 3. How does the study treatment effect the immune system in patients with colorectal cancer? Participants in this study will receive the study treatment and undergo checkups, laboratory tests, and imaging tests for monitoring. Some participants will also undergo tumor biopsies.

Detailed description

This is a phase II study investigating the efficacy and safety of a triple-combination immunotherapy regimen in patients diagnosed with microsatellite stable metastatic colorectal cancer (MSS mCRC), refractory to fluorouracil, oxaliplatin, and irinotecan chemotherapy. The trial is designed as a single-arm, Simon two-stage study. All participants will receive a fixed-dose regimen of the three agents: atezolizumab (1200 mg), bevacizumab (15 mg/kg), and tiragolumab (600 mg), administered intravenously on day 1 of 21-day cycles. Treatment response will be assessed by imaging using RECIST v1.1 every 9 weeks. Study treatment will be continued until disease progression, unacceptable toxicity, death, decision by the patient and/or treating physician to withdraw from the study, pregnancy, or study termination, whichever occurs first. This study will enroll patients in 2 cohorts: A and B. Patients in Cohort A will undergo pre-treatment and on-treatment tumor biopsies for correlative studies. Patient in Cohort B will not receive study biopsies. Patients in Cohorts A and B will otherwise receive identical treatment.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Pre-Treatment Biopsy	The pre-treatment biopsy should be performed at least 3 days prior to C1D1 of treatment.
PROCEDURE	On-Treatment Biopsy	While the acceptable window for the C3D1 biopsy is ±3 days, it is preferred that the biopsy occurs following all treatments on C3D1.
DRUG	Tiragolumab	Tiragolumab is a human monoclonal antibody targeting the co-inhibitory molecule and immune checkpoint inhibitor T-cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibitory motif (ITIM) domains (TIGIT), with potential immune checkpoint inhibitory activity. This treatment may help the immune system attack cancer cells.
DRUG	Atezolizumab	Atezolizumab is a type of targeted therapy drug called an immune checkpoint inhibitor. It is a monoclonal antibody that works by binding to the protein PD-L1 (programmed death) on the surface of some cancer cells, which keeps cancer cells from suppressing the immune system. This allows the immune system to attack and kill the cancer cells.
DRUG	Bevacizumab	Bevacizumab works by blocking a protein called Vascular Endothelial Growth Factor (VEGF), which some cancer cells produce in large amounts. Blocking VEGF may prevent the growth of new blood vessels that tumors need to grow, and may help improve the immune response in the tumor. Bevacizumab is a type of targeted therapy called an angiogenesis inhibitor.

Timeline

Start date: 2025-03-25
Primary completion: 2025-09-18
Completion: 2028-05-01
First posted: 2025-01-20
Last updated: 2025-10-02

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06784947. Inclusion in this directory is not an endorsement.