Study on New Treatments and Combinations for Colorectal Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT06792695

Provider View

This clinical trial is testing the safety and effectiveness of new treatment combinations for patients with colorectal cancer. The study compares a new drug combination with a standard treatment to see which works better for patients with specific types of colorectal cancer.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of new treatment combinations for colorectal cancer. Participants will be randomly assigned to receive either a new combination of drugs (Volrustomig with FOLFIRI and bevacizumab) or the standard treatment (FOLFIRI with bevacizumab). The study focuses on patients with a specific type of colorectal cancer that has not spread to the liver and who have not received previous treatment for advanced cancer.

Description

This is a Phase II study conducted at multiple centers around the world. It includes a main protocol and several substudies. Participants will be randomly assigned to one of two groups:

  • Group A: Volrustomig combined with FOLFIRI (a chemotherapy regimen including irinotecan, 5-FU, and leucovorin) and bevacizumab.
  • Group B: FOLFIRI combined with bevacizumab only.

The study will compare the effects of adding Volrustomig to the standard treatment in patients with a specific type of colorectal cancer that has not spread to the liver and who have not received previous treatment for advanced cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with colorectal adenocarcinoma confirmed by lab tests.
  • Provide a tumor sample as part of standard care.
  • Have measurable cancer 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 a life expectancy of at least 12 weeks.

Substudy Inclusion Criteria:

  • No signs of cancer spread to the liver.
  • No previous treatment for metastatic colorectal cancer, except for certain chemotherapy completed more than 6 months before the cancer returned or spread.
  • Have a specific genetic status (pMMR/MSS) required for the study.
  • Have good organ and bone marrow function.
  • Weigh more than 35 kg at screening and randomization.
  • Use contraception as required by local regulations for clinical studies.

Exclusion Criteria

  • Cancer spread to the brain or spinal cord.
  • Severe allergy to any study drug or similar treatments.
  • Unresolved side effects from previous cancer treatments.
  • History of another type of cancer.

Substudy Exclusion Criteria:

  • Cancer that can be surgically removed with a plan for surgery.
  • Active or past autoimmune or inflammatory disorders or heart conditions.
  • History of severe high blood pressure or bleeding risks.
  • History of blood clots or strokes.
  • History of certain abdominal or esophageal conditions within 6 months before the study.
  • Previous treatment with immune-based therapies.

Locations

FACILITYZIPCITYSTATE
Research Site85259ScottsdaleArizona
Research Site90089Los AngelesCalifornia
Research Site20007WashingtonDistrict of Columbia
Research Site60637ChicagoIllinois
Research Site21224BaltimoreMaryland
Research Site02114BostonMassachusetts
Research Site55905RochesterMinnesota
Research Site14618RochesterNew York
Research Site44106ClevelandOhio
Research Site97239PortlandOregon

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