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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
Sponsor: Pfizer
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.
Official title: A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
840
Start Date
2026-05-14
Completion Date
2033-01-14
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
PF-08634404
Participants will receive PF-08634404 intravenously.
Chemotherapy
Participants will receive PF-08634404 intravenously in combination with Chemotherapy.
Nivolumab
Participants will receive Nivolumab intravenously.
Locations (102)
UCLA Hematology/Oncology - Atascadero
Atascadero, California, United States
UCLA Hematology/Oncology - Burbank
Burbank, California, United States
UCLA Hematology/Oncology - Encino
Encino, California, United States
UCLA Hematology/Oncology - Marina del Rey
Marina del Rey, California, United States
UCLA Hematology/Oncology - Porter Ranch
Porter Ranch, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
UCSF Investigational Drugs Pharmacy
San Francisco, California, United States
UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo, California, United States
UCLA Hematology/Oncology - Santa Barbara
Santa Barbara, California, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Boulder, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Centennial, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Englewood, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Longmont, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Thornton, Colorado, United States
Florida Cancer Specialists
Daytona Beach, Florida, United States
Florida Cancer Specialists
Fleming Island, Florida, United States
Florida Cancer Specialists
Palm Beach Gardens, Florida, United States
Florida Cancer Specialists
Sebring, Florida, United States
Florida Cancer Specialists
Wellington, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States
Illinois Cancer Specialists
Chicago, Illinois, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare, P.C.
Peoria, Illinois, United States
Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru, Illinois, United States
Illinois CancerCare-Washington
Washington, Illinois, United States
Maryland Oncology Hematology, P.A.
Annapolis, Maryland, United States
Maryland Oncology Hematology, P.A.
Bethesda, Maryland, United States
Maryland Oncology Hematology, P.A.
Brandywine, Maryland, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Maryland Oncology Hematology, P.A.
Germantown, Maryland, United States
Maryland Oncology Hematology, P.A.
Largo, Maryland, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, United States
Renown Health Medical Oncology
Reno, Nevada, United States
Renown Office of Clinical Research
Reno, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
Atlantic Health System
Morristown, New Jersey, United States
Atlantic Health System / Overlook Medical Center
Summit, New Jersey, United States
Memorial Sloan Kettering Cancer Center Pharmacy (IMP ship to address)
Long Island City, New York, United States
Memorial Sloan Kettering Cancer Center Pharmacy (IMP storage location)
Long Island City, New York, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, United States
Rockefeller Outpatient Pavilion (53rd Street)
New York, New York, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States
Oncology Hematology Care Clinical Trials, LLC
Fairfield, Ohio, United States
Alliance Cancer Specialists, PC
Bensalem, Pennsylvania, United States
Alliance Cancer Specialists, PC
Doylestown, Pennsylvania, United States
Alliance Cancer Specialists, PC
Horsham, Pennsylvania, United States
Alliance Cancer Specialists, PC
Langhorne, Pennsylvania, United States
Alliance Cancer Specialists, PC
Media, Pennsylvania, United States
Alliance Cancer Specialists, PC
Sellersville, Pennsylvania, United States
Alliance Cancer Specialists, PC
Wynnewood, Pennsylvania, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, United States
Virginia Cancer Specialists, PC
Arlington, Virginia, United States
Virginia Oncology Associates
Chesapeake, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Oncology Associates
Hampton, Virginia, United States
Virginia Cancer Specialists, PC
Manassas, Virginia, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Cancer Specialists, PC
Reston, Virginia, United States
Virginia Oncology Associates
Virginia Beach, Virginia, United States
Virginia Cancer Specialists, PC
Woodbridge, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
London Health Sciences Centre - Verspeeten Family Cancer Centre
London, Ontario, Canada
The Sixth Affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Sichuan Cancer hospital
Chengdu, Sichuan, China
Hôpital Européen Georges Pompidou
Paris, France
Rabin Medical Center
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, HA Merkaz, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, Israel
Istituto Europeo di Oncologia IRCCS
Milan, Italy
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Pan American Center for Oncology Trials, LLC - Manati Office
Manati, United States, Puerto Rico
Pan American Center for Oncology Trials, LLC - Bayamón Office
Bayamón, Puerto Rico
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Ourense [orense], Spain
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan