Clinical Trial: Atezolizumab and Bevacizumab in Rare Solid Tumors

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II, Single-Arm Open-Label Study Of The Combination Of Atezolizumab And Bevacizumab In Rare Solid Tumors

Brief Summary: The goal of this clinical research study is to learn if atezolizumab and bevacizumab can help to control rare solid tumors.

Detailed Summary:

Study Drug Administration:

Each cycle is 21 days.

On Day 1 of each cycle, you will receive atezolizumab and bevacizumab by vein over about 60 minutes each.

Length of Treatment:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Study Visits:

On Day 1 of every odd-numbered cycle (Cycles 1, 3, 5, and so on):

°°You will have a physical exam. Blood (about 4 teaspoons) will be drawn for routine tests and to learn if you have certain genetic mutations (changes) that may affect your response to the study drugs.

°Urine will be collected for routine tests.

On Day 1 of every even-numbered cycle (Cycles 2, 4, 6, and so on):

  • You will have a physical exam.
  • Blood (about 4 teaspoons) will be drawn for routine testing.
  • During Cycle 2, blood (about 2 teaspoons) will be drawn before your dose of study drugs for biomarker testing.
  • During Cycle 2, you will have an image-guided core biopsy to check the status of the disease and for biomarker testing.

Response determined by an independent radiologist according to RECIST v1.1.



Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse Events of Atezolizumab in Combination with Bevacizumab [ Time Frame: 6 months ]

Occurrence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0.


Original Secondary Outcome: Same as current

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: February 22, 2017
Date Started: March 3, 2017
Date Completion: March 2021
Last Updated: May 4, 2017
Last Verified: May 2017