Clinical Trial of All-trans-retinoic Acid, Bevacizumab and Atezolizumab in Colorectal Cancer

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05999812
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • all trans Retinoic Acid — DRUG
    ATRA orally 45 mg/m2 QD in 2 divided doses days 1-7, repeat every 14 days
  • Atezolizumab — DRUG
    Atezolizumab IV D1, 840 mg every 14 days
  • Bevacizumab — DRUG
    Bevacizumab IV D1, 10 mg/kg every 14 days

Study Details

The main purpose of this clinical trial is to learn about the good and the bad effects of all trans retinoic acid (ATRA), atezolizumab and bevacizumab as a possible treatment for advanced colorectal patients. Participants will be treated with the following combination of these drugs: 1. ATRA will be given in a pill form to be taken twice a day at home for 7 days starting on day 1 of a cycle. 2. Atezolizumab will be given through a vein in arm or through mediport over 60-90 minutes every 2 weeks in the outpatient chemotherapy infusion centers at UTSW. 3. Bevacizumab will be given through a vein in arm or through mediport over 20-40 minutes every 2 weeks in the outpatient chemotherapy infusion centers at UTSW.

Key Dates

Start date
Dec 19, 2023
Status verified
May 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2028

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    * ATRA orally 45 mg/m2 daily in 2 divided doses days 1-7, repeat every 14 days * Atezolizumab IV D1, 840 mg every 14 days * Bevacizumab IV D1, 10 mg/kg every 14 days

Primary Outcome Measure

Objective Response Rate of of ATRA, bevacizumab and atezolizumab combination [ Time Frame: From time of enrollment/treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Texas Southwestern Medical Center· Dallas, TX

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