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Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer

RecruitingPhase 3Ages 18 Years - anyAllPfizer
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In plain words

What the trial is, and whether it could suit you

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. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have colorectal cancer that has spread to other parts of your body. * Be in good enough health to receive study treatment. * Should not be pregnant before starting treatment. Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will incl

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Histological or cytological confirmed colorectal adenocarcinoma. * Evidence of Stage IV metastatic disease. * No prior systemic therapy for metastatic disease. * Eastern Cooperative Oncology Group performance status (ECOG) 0-1 * At least one measurable lesion according to RECIST 1.1 per Investigator assessment. * Adequate hepatic, liver, and renal function Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Locally confirmed BRAF V600E mutation * Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer * Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression * Clinically significant risk of hemorrhage or fistula * Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study * History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation * Any Grade โ‰ฅ3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events * Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose * Participants with active autoimmune diseases requiring systemic treatment within the past 2 years * Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis
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What it tests

  • PF-08634404
  • Bevacizumab
  • Chemotherapy
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Where

372 sites
Ironwood Cancer & Research Centers
Chandler, United States
Banner Gateway Medical Center
Gilbert, United States
Banner MD Anderson Cancer Center
Gilbert, United States
Ironwood Cancer & Research Centers
Gilbert, United States
Ironwood Cancer & Research Centers
Glendale, United States
Ironwood Cancer & Research Centers
Goodyear, United States
Ironwood Cancer & Research Centers
Mesa, United States
Ironwood Cancer & Research Centers
Mesa, United States

โ€ฆand 364 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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