Study on Atezolizumab and Bevacizumab for Treating Rare Solid Tumors

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03074513

Provider View

This clinical trial is exploring how well the combination of two immunotherapy drugs, atezolizumab and bevacizumab, works in treating patients with rare types of solid tumors. These drugs may help the immune system attack cancer cells and prevent them from growing and spreading.

Patient Parameters

Program Overview

The purpose of this study is to see if the combination of atezolizumab and bevacizumab can effectively treat rare solid tumors by helping the immune system target and destroy cancer cells. The study will also look at the safety of this treatment and identify any markers that might predict how well patients respond to the therapy.

Description

In this study, patients will receive atezolizumab and bevacizumab through an IV drip over 60 minutes on the first day of each treatment cycle. These cycles will repeat every 21 days as long as the cancer does not progress and the treatment is tolerated well. After finishing the treatment, patients will have follow-up visits every three months to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must sign a consent form and be able to follow the study protocol.
  • Have a measurable tumor according to specific medical criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must agree to use effective contraception during and for six months after treatment.
  • Have specific types of rare solid tumors, such as:
    • Metastatic appendiceal adenocarcinoma not suitable for surgery.
    • Metastatic or recurrent nasopharyngeal carcinoma not treatable with surgery.
    • HPV-associated cancers like anal, penile, vaginal, vulvar, or cervical cancer that have progressed after treatment.
    • Metastatic or recurrent Merkel cell carcinoma.
    • Neuroendocrine tumors of the pancreas or other areas that have progressed in the last year.
    • Refractory peritoneal mesothelioma.
    • Metastatic or recurrent pleural mesothelioma not treatable with surgery.

Exclusion Criteria

  • Recent treatment for the studied cancer or with investigational therapy within 28 days before starting the study.
  • Severe allergic reactions to similar drugs or components of atezolizumab or bevacizumab.
  • Active or history of autoimmune diseases or immune deficiencies, with some exceptions for controlled conditions.
  • Prior organ or stem cell transplants.
  • Certain lung diseases or active lung inflammation.
  • Active infections like HIV, hepatitis B or C, or tuberculosis.
  • Recent severe infections or use of antibiotics.
  • Significant heart disease or recent major surgery.
  • Recent live vaccinations.
  • Other cancers within the last five years, except for certain non-threatening types.
  • Pregnant or breastfeeding women, or those planning to become pregnant during the study.
  • Uncontrolled high blood pressure or recent stroke.
  • Certain vascular diseases or heart conditions.
  • Recent use of specific blood-thinning medications.
  • Serious wounds or bone fractures.
  • Specific conditions related to the types of tumors being studied, such as bowel obstruction in appendiceal adenocarcinoma.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.