Trial of Atezolizumab, Bevacizumab, and Tiragolumab in Patients With Microsatellite Stable, Metastatic Colorectal Cancer
NCT06784947 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2025-10-02
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.
Conditions
- Microsatellite Stable (MSS) Colorectal Cancer (CRC)
- Metastatic Colorectal Cancer (CRC)
- Colorectal Cancer Stage IV
Interventions
- 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 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 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.
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY -
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Hannah Robinson, MD · University of Colorado, Denver
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-25
- Primary Completion
- 2025-09-18
- Completion
- 2028-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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