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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06784947
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Colorectal Cancer Stage IV
  • Metastatic Colorectal Cancer (CRC)
  • Microsatellite Stable (MSS) Colorectal Cancer (CRC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pre-Treatment Biopsy — PROCEDURE
    The pre-treatment biopsy should be performed at least 3 days prior to C1D1 of treatment.
  • On-Treatment Biopsy — PROCEDURE
    While the acceptable window for the C3D1 biopsy is ±3 days, it is preferred that the biopsy occurs following all treatments on C3D1.
  • Tiragolumab — DRUG
    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.
  • Atezolizumab — 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.
  • Bevacizumab — 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.

Study Details

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.

Key Dates

Start date
Mar 25, 2025
Status verified
Oct 2025
Primary completion
Sep 18, 2025
Completion
May 31, 2028

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with Biopsy
    Patients in Cohort A will undergo pre-treatment and on-treatment tumor biopsies for correlative analyses, with on-treatment biopsies obtained at cycle 3, day 1 (C3D1) +/- 3 days of treatment.
  • Experimental: Treatment without Biopsy
    In Cohort B, no study-related biopsies will be obtained. Outside of pre- and on-treatment biopsies, patients in Cohort A and Cohort B will receive identical treatments and assessments.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From time of study start to time of best response, up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Universtiy of Colorado HospitalAuroraColorado80045-

Find similar trials in Aurora, CO

By research site
Universtiy of Colorado Hospital· Aurora, CO

Related Studies