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Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllPfizer
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In plain words

What the trial is, and whether it could suit you

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: Be 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naรฏve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests. The study has two parts: * In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it. * In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see whi

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 gastric, gastroesophageal junction or esophageal adenocarcinoma. * Evidence of locally advanced or metastatic disease. * Eastern Cooperative Oncology Group performance status (ECOG) 0-1 * No prior systemic therapy for advanced or metastatic disease. * Adequate hepatic, liver, and renal function * HER-2 negative status based on local testing * PD-L1 positive status based on local testing Exclusion Criteria: * Participants with known active CNS metastases, including leptomeningeal, 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
  • Chemotherapy
  • Nivolumab
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Where

102 sites
UCLA Hematology/Oncology - Atascadero
Atascadero, United States
UCLA Hematology/Oncology - Burbank
Burbank, United States
UCLA Hematology/Oncology - Encino
Encino, United States
UCLA Hematology/Oncology - Marina del Rey
Marina del Rey, United States
UCLA Hematology/Oncology - Porter Ranch
Porter Ranch, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, United States
UCSF Investigational Drugs Pharmacy
San Francisco, United States
UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo, United States

โ€ฆand 94 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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