Phase III Study of Ivonescimab or Bevacizumab with FOLFOX for Metastatic Colorectal Cancer
Sponsor: Summit Therapeutics
ClinicalTrials ID:NCT07228832
This clinical trial is testing two different drug combinations to see which is more effective as a first treatment for patients with metastatic colorectal cancer. The study compares Ivonescimab with chemotherapy against Bevacizumab with the same chemotherapy.
Patient Parameters
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Program Overview
The purpose of this study is to compare two treatment options for patients with metastatic colorectal cancer who have not yet received treatment for their cancer. The study will test Ivonescimab combined with a chemotherapy regimen called mFOLFOX6 against Bevacizumab combined with the same chemotherapy. About 600 patients will participate, and they will be randomly assigned to one of the two treatment groups. Participants will receive the treatment every two weeks for up to 8 cycles, followed by a maintenance treatment for up to 2 years.
Description
This study is a Phase III trial, which means it is testing the effectiveness and safety of two different treatment combinations for metastatic colorectal cancer. The trial is double-blind, meaning neither the participants nor the researchers know which treatment each participant is receiving, to ensure unbiased results. Participants will be randomly assigned to receive either Ivonescimab with mFOLFOX6 or Bevacizumab with mFOLFOX6. The chemotherapy regimen includes drugs called Oxaliplatin, Leucovorin, and 5-Fluorouracil. After the initial treatment period, participants will continue with a maintenance treatment that includes Ivonescimab or Bevacizumab with 5-Fluorouracil and Leucovorin every two weeks for up to two years. The goal is to determine which combination is more effective in treating metastatic colorectal cancer.
Eligibility Criteria
Inclusion Criteria
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Expected to live for at least 6 more months.
- Must have a confirmed diagnosis of metastatic colorectal cancer.
- Must not have received any prior treatment for metastatic colorectal cancer.
- Must have at least one measurable tumor outside the brain.
Exclusion Criteria
- Cannot have a type of cancer known as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
- Cannot have a known BRAF V600E mutation.
- Cannot have significant symptoms of gastrointestinal blockage.
- Cannot have fluid buildup in the abdomen that required drainage in the last 30 days.
- Cannot have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer.
- Cannot have a history of inflammatory bowel disease like Crohn's disease or ulcerative colitis.
- Cannot have cancer that can be surgically removed.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clinical Study Site | 90067 | Los Angeles | California |
| Clinical Study Site | 92562 | Murrieta | California |
| Clinical Study Site | 68506 | Lincoln | Nebraska |
| Clinical Study Site | 99208 | Spokane | Washington |
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