Study on Combination Chemotherapy, Bevacizumab, and/or Atezolizumab for Treating Metastatic Colorectal Cancer with DNA Repair Deficiency

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02997228

Provider View

This clinical trial is exploring how well a combination of chemotherapy, bevacizumab, and/or atezolizumab works in treating patients with colorectal cancer that has spread and has a specific DNA repair deficiency. The study aims to find the best treatment approach to control the cancer's growth and spread.

Patient Parameters

Program Overview

This phase III study is testing different combinations of treatments to see how well they work for patients with colorectal cancer that has spread to other parts of the body and has a specific DNA repair issue. The treatments being tested include chemotherapy drugs (fluorouracil, oxaliplatin, and leucovorin calcium), bevacizumab, which may slow cancer by blocking blood vessel growth, and atezolizumab, an immunotherapy that helps the immune system attack cancer cells. The goal is to find out if these combinations can better control the cancer compared to using atezolizumab alone.

Description

The main goal of this study is to see if a combination of chemotherapy drugs (fluorouracil, oxaliplatin, and leucovorin calcium) with bevacizumab and atezolizumab can help patients live longer without their cancer getting worse, compared to using atezolizumab alone. The study will also look at overall survival rates, how well the cancer responds to treatment, and the safety of these treatments.

Patients will be randomly assigned to one of three groups:

  • Group 1: Receives bevacizumab, oxaliplatin, leucovorin calcium, and fluorouracil. This treatment is given every two weeks for up to 48 cycles, with oxaliplatin given for up to 10 cycles.
  • Group 2: Receives atezolizumab every two weeks for up to 48 cycles.
  • Group 3: Receives a combination of atezolizumab, bevacizumab, oxaliplatin, leucovorin calcium, and fluorouracil, similar to Group 1.

Throughout the study, patients will have regular scans and may provide blood samples to monitor their health and the cancer's response to treatment. After finishing the study treatment, patients will have follow-up visits every 8 weeks for 18 months, then every 12 weeks for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of metastatic colorectal cancer with a specific DNA repair deficiency.
  • Have not received previous chemotherapy for metastatic colorectal cancer, except for one cycle of specific treatments.
  • Have measurable cancer that can be tracked by scans.
  • Have good overall health with an ECOG performance status of 0, 1, or 2.
  • Have adequate blood cell counts and organ function based on specific lab tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
  • Men must agree to use effective birth control and not donate sperm during and after the study.

Exclusion Criteria

  • Known allergies to any of the study drugs or similar medications.
  • Uncontrolled high blood pressure or serious heart conditions.
  • Recent major surgery or significant injuries.
  • Active infections or recent use of antibiotics.
  • Pregnant or breastfeeding women.
  • History of other cancers unless treated and disease-free for at least 12 months.
  • Known liver disease or autoimmune disorders that are not well-controlled.
  • Recent use of certain immunosuppressive medications.
  • Previous treatment with similar immunotherapy drugs.

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