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ATRA + Bevacizumab + Atezolizumab for Colorectal Cancer

Phase 2

Recruiting

Led By Syed Kazmi, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The eligible patient's tumors be classified as proficient in DNA mismatch repair (pMMR) by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2. Tumors with intact expression of all MMR proteins will be considered pMMR.

Histologically proven stage IV colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1- 2, M1). Tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effects of a combination of drugs (ATRA, atezolizumab, and bevacizumab) as a potential treatment for advanced colorectal cancer. Participants

Who is the study for?

This trial is for adults over 18 with advanced stage IV colon adenocarcinoma. They must have tried at least two systemic chemotherapies and their tumors should be proficient in DNA mismatch repair or stable microsatellite status. Adequate organ function and certain blood levels are required.

What is being tested?

The trial tests a combination of ATRA (pill form), Atezolizumab, and Bevacizumab (both via vein) on colorectal cancer patients to assess the benefits and side effects. Treatments occur every two weeks at UTSW outpatient centers.

What are the potential side effects?

Potential side effects include reactions related to infusion, increased bleeding risk due to Bevacizumab, immune-related issues from Atezolizumab, and skin changes or headaches from ATRA.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is proficient in DNA repair, as shown by a specific test.

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My cancer is a type of colon cancer that has spread to other parts of my body.

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate of of ATRA, bevacizumab and atezolizumab combination

Secondary study objectives

Disease Control Rate of of ATRA, bevacizumab and atezolizumab combination

Frequency of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment3 Interventions

* 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Bevacizumab

2013

Completed Phase 4

~5540