Active, not yet recruiting
AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER
NCT No.: NCT07222800
Study Type: INTERVENTIONAL
Phase:
Phase III
Official Title
AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER
Purpose
This study will compare treatment effects of PF-08634404 + chemotherapy as opposed to bevacizumab + chemotherapy for treating colorectal cancer.
Detailed Description
The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.
Eligibility Criteria
Inclusion Criteria
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1) Histological or cytological confirmed colorectal adenocarcinoma.
2) Evidence of Stage IV metastatic disease.
3) Eastern Cooperative Oncology Group performance status (ECOG) 0-1
4) At least one measurable lesion according to RECIST 1.1 per Investigator assessment.
5) Adequate hepatic, liver, and renal function
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Exclusion Criteria
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1) Locally confirmed BRAF V600E mutation
2) Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer
3) Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.
4) Clinically significant risk of hemorrhage or fistula
5) Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
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Keywords and/or Specific Medical Conditions
Sponsors
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