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NCT07392892PHASE2, PHASE3Recruiting

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

Pfizer

Start Date

5/14/2026

Completion Date

7/21/2032

Summary

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 naïve 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 which works better. The treatment will be given in repeated time periods called cycles.

Eligibility Criteria

Age Range: 18 years to No maximum

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 ≥3 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

Interventions

BIOLOGICAL

PF-08634404

DRUG

Chemotherapy

BIOLOGICAL

Nivolumab

Interested in This Trial?

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Conditions

Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal AdenocarcinomaMetastatic Gastric CancerGastroesophageal Junction CancerEsophageal Adenocarcinoma

Locations

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado 80012

United States

Rocky Mountain Cancer Centers, LLP

Boulder, Colorado 80303

United States

Rocky Mountain Cancer Centers, LLP

Centennial, Colorado 80112

United States

Rocky Mountain Cancer Centers, LLP

Colorado Springs, Colorado 80907

United States

Rocky Mountain Cancer Centers, LLP

Colorado Springs, Colorado 80923

United States

Rocky Mountain Cancer Centers, LLP

Denver, Colorado 80218

United States

Rocky Mountain Cancer Centers, LLP

Denver, Colorado 80220

United States

Rocky Mountain Cancer Centers, LLP

Englewood, Colorado 80113

United States

Rocky Mountain Cancer Centers, LLP

Lakewood, Colorado 80228

United States

Rocky Mountain Cancer Centers, LLP

Littleton, Colorado 80120

United States

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado 80124

United States

Rocky Mountain Cancer Centers, LLP

Longmont, Colorado 80504

United States

Rocky Mountain Cancer Centers, LLP

Pueblo, Colorado 81003

United States

Rocky Mountain Cancer Centers, LLP

Thornton, Colorado 80260

United States

Illinois Cancer Specialists

Arlington Heights, Illinois 60005

United States

Illinois CancerCare - Bloomington

Bloomington, Illinois 61704

United States

Illinois Cancer Specialists

Chicago, Illinois 60631

United States

Illinois CancerCare - Galesburg

Galesburg, Illinois 61401

United States

Illinois Cancer Specialists

Niles, Illinois 60714

United States

Illinois CancerCare-Ottawa-Fox River Cancer Center

Ottawa, Illinois 61350

United States

Illinois CancerCare-Pekin

Pekin, Illinois 61554

United States

Illinois CancerCare, P.C.

Peoria, Illinois 61615

United States

Illinois CancerCare-Peru - Valley Regional Cancer Center

Peru, Illinois 61354

United States

Illinois CancerCare-Washington

Washington, Illinois 61571

United States

Maryland Oncology Hematology, P.A.

Annapolis, Maryland 21401

United States

Maryland Oncology Hematology, P.A.

Bethesda, Maryland 20817

United States

Maryland Oncology Hematology, P.A.

Brandywine, Maryland 20613

United States

Maryland Oncology Hematology, P.A.

Columbia, Maryland 21044

United States

Maryland Oncology Hematology, P.A.

Germantown, Maryland 20876

United States

Maryland Oncology Hematology, P.A.

Largo, Maryland 20774

United States

Maryland Oncology Hematology, P.A.

Rockville, Maryland 20850

United States

Maryland Oncology Hematology, P.A.

Silver Spring, Maryland 20904

United States

Renown Health Medical Oncology

Reno, Nevada 89502

United States

Renown Office of Clinical Research

Reno, Nevada 89502

United States

Renown Regional Medical Center

Reno, Nevada 89502

United States

Atlantic Health System

Morristown, New Jersey 07960

United States

Atlantic Health System / Overlook Medical Center

Summit, New Jersey 07901

United States

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio 45211

United States

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio 45242

United States

Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio 45245

United States

Oncology Hematology Care Clinical Trials, LLC

Fairfield, Ohio 45014

United States

Alliance Cancer Specialists, PC

Bensalem, Pennsylvania 19020

United States

Alliance Cancer Specialists, PC

Doylestown, Pennsylvania 18901

United States

Alliance Cancer Specialists, PC

Horsham, Pennsylvania 19044

United States

Alliance Cancer Specialists, PC

Langhorne, Pennsylvania 19047

United States

Alliance Cancer Specialists, PC

Media, Pennsylvania 19063

United States

Alliance Cancer Specialists, PC

Sellersville, Pennsylvania 18960

United States

Alliance Cancer Specialists, PC

Wynnewood, Pennsylvania 19096

United States

US Oncology Investigational Products Center (IPC)

Irving, Texas 75063

United States

Virginia Cancer Specialists, PC

Arlington, Virginia 22201

United States

Virginia Oncology Associates

Chesapeake, Virginia 23320

United States

Virginia Cancer Specialists, PC

Fairfax, Virginia 22031

United States

Virginia Oncology Associates

Hampton, Virginia 23666

United States

Virginia Cancer Specialists, PC

Manassas, Virginia 20110

United States

Virginia Oncology Associates

Newport News, Virginia 23606

United States

Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Virginia Cancer Specialists, PC

Reston, Virginia 20190

United States

Virginia Oncology Associates

Virginia Beach, Virginia 23456

United States

Virginia Cancer Specialists, PC

Woodbridge, Virginia 22191

United States

Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality 200031

China

Rabin Medical Center

Petah Tikva, Central District 4941492

Israel

Sheba Medical Center

Ramat Gan, HA Merkaz 5265601

Israel

Sourasky Medical Center

Tel Aviv, TELL ABĪB 6423906

Israel

Istituto Europeo di Oncologia IRCCS

Milan, 20141

Italy

Aichi Cancer Center

Nagoya, Aichi-ken 464-8681

Japan

Pan American Center for Oncology Trials, LLC - Manati Office

Manati, United States 00674

Puerto Rico

Pan American Center for Oncology Trials, LLC - Bayamón Office

Bayamón, 00959

Puerto Rico

National Cheng Kung University Hospital

Tainan, 704302

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan