Sign in

NCT07392892RecruitingPhase 2/3

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

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

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
840 (estimated)
First submitted
30 Jan 2026
Start date
14 May 2026
Primary completion date
22 Jul 2031
Lead sponsor
Pfizer
NCT number
NCT07392892
EU CT number
2025-524717-86-00

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 840
  • From 14 May 2026 to the primary completion date, 22 Jul 2031
  • 99 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
  • 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

Other illness

  • Clinically significant risk of hemorrhage or fistula
  • History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • 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

Other

  • Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (99)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
London Health Sciences Centre - Verspeeten Family Cancer Centre
Coordinator of this site? Confirm its status
LondonCanadaNot yet recruiting
Sichuan Cancer Hospital
Coordinator of this site? Confirm its status
ChengduChinaRecruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Zhongshan Hospital,Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Hubei Cancer Hospital
Coordinator of this site? Confirm its status
WuhanChinaRecruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Complejo Hospitalario Universitario de Ourense
Coordinator of this site? Confirm its status
OurenseSpainRecruiting
Institut Paoli-Calmettes
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Assistance Publique Hopitaux de Paris
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Rabin Medical Center
Coordinator of this site? Confirm its status
Petah TikvaIsraelRecruiting
Sheba medical center
Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
Sourasky Medical Center
Coordinator of this site? Confirm its status
Tel AvivIsraelRecruiting
Istituto Europeo di Oncologia s.r.l
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Aichi Cancer Center
Coordinator of this site? Confirm its status
NagoyaJapanRecruiting
Pan American Center for Oncology Trials, LLC - Bayamón Office
Coordinator of this site? Confirm its status
BayamónPuerto RicoRecruiting
Pan American Center for Oncology Trials, LLC - Manati Office
Coordinator of this site? Confirm its status
ManatiPuerto RicoRecruiting
National Cheng Kung University Hospital
Coordinator of this site? Confirm its status
TainanTaiwanRecruiting
Taipei Veterans General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Maryland Oncology Hematology P.A.
Coordinator of this site? Confirm its status
AnnapolisUnited StatesRecruiting
Virginia Cancer Specialists, PC
Coordinator of this site? Confirm its status
ArlingtonUnited StatesRecruiting
Illinois Cancer Specialists
Coordinator of this site? Confirm its status
Arlington HeightsUnited StatesRecruiting
UCLA Hematology/Oncology - Atascadero
Coordinator of this site? Confirm its status
AtascaderoUnited StatesRecruiting
Rocky Mountain Cancer Centers,LLP
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
Alliance Cancer Specialists, PC
Coordinator of this site? Confirm its status
BensalemUnited StatesRecruiting
Maryland Oncology Hematology P.A.
Coordinator of this site? Confirm its status
BethesdaUnited StatesRecruiting
Illinois CancerCare-Bloomington
Coordinator of this site? Confirm its status
BloomingtonUnited StatesRecruiting
Rocky Mountain Cancer Centers LLP
Coordinator of this site? Confirm its status
BoulderUnited StatesRecruiting
Maryland Oncology Hematology P.A.
Coordinator of this site? Confirm its status
BrandywineUnited StatesRecruiting
UCLA Hematology/Oncology - Burbank
Coordinator of this site? Confirm its status
BurbankUnited StatesRecruiting
Rocky Mountain Cancer Centers LLP
Coordinator of this site? Confirm its status
CentennialUnited StatesRecruiting
Virginia Oncology Associates
Coordinator of this site? Confirm its status
ChesapeakeUnited StatesRecruiting
Illinois Cancer Specialists
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Oncology Hematology Care Clinical Trials LLC
Coordinator of this site? Confirm its status
CincinnatiUnited StatesRecruiting
Rocky Mountain Cancer Centers LLP
Coordinator of this site? Confirm its status
Colorado SpringsUnited StatesRecruiting
Maryland Oncology Hematology P.A.
Coordinator of this site? Confirm its status
ColumbiaUnited StatesRecruiting
Florida Cancer Specialists
Coordinator of this site? Confirm its status
Daytona BeachUnited StatesNot yet recruiting
Rocky Mountain Cancer Centers, LLP
Coordinator of this site? Confirm its status
DenverUnited StatesRecruiting
Alliance Cancer Specialists, PC
Coordinator of this site? Confirm its status
DoylestownUnited StatesRecruiting
UCLA Hematology/Oncology - Encino
Coordinator of this site? Confirm its status
EncinoUnited StatesRecruiting
Rocky Mountain Cancer Centers LLP
Coordinator of this site? Confirm its status
EnglewoodUnited StatesRecruiting
Virginia Cancer Specialists PC
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
Oncology Hematology Care Clinical Trials, LLC
Coordinator of this site? Confirm its status
FairfieldUnited StatesRecruiting
Florida Cancer Specialists
Coordinator of this site? Confirm its status
Fleming IslandUnited StatesNot yet recruiting
Illinois CancerCare-Galesburg
Coordinator of this site? Confirm its status
GalesburgUnited StatesRecruiting
Maryland Oncology Hematology P.A.
Coordinator of this site? Confirm its status
GermantownUnited StatesRecruiting
Virginia Oncology Associates
Coordinator of this site? Confirm its status
HamptonUnited StatesRecruiting
Alliance Cancer Specialists, PC
Coordinator of this site? Confirm its status
HorshamUnited StatesRecruiting
US Oncology Investigational Products Center (IPC)
Coordinator of this site? Confirm its status
IrvingUnited StatesRecruiting
Rocky Mountain Cancer Centers LLP
Coordinator of this site? Confirm its status
LakewoodUnited StatesRecruiting
Alliance Cancer Specialists, PC
Coordinator of this site? Confirm its status
LanghorneUnited StatesRecruiting
Maryland Oncology Hematology P.A.
Coordinator of this site? Confirm its status
LargoUnited StatesRecruiting
Rocky Mountain Cancer Centers LLP
Coordinator of this site? Confirm its status
LittletonUnited StatesRecruiting
Rocky Mountain Cancer Centers,LLP
Coordinator of this site? Confirm its status
Lone TreeUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center Pharmacy (IMP ship to address)
Coordinator of this site? Confirm its status
Long Island CityUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center Pharmacy (IMP storage location)
Coordinator of this site? Confirm its status
Long Island CityUnited StatesRecruiting
Rocky Mountain Cancer Centers LLP
Coordinator of this site? Confirm its status
LongmontUnited StatesRecruiting
Virginia Cancer Specialists, PC
Coordinator of this site? Confirm its status
ManassasUnited StatesRecruiting
UCLA Hematology/Oncology - Marina del Rey
Coordinator of this site? Confirm its status
Marina del ReyUnited StatesRecruiting
Alliance Cancer Specialists, PC
Coordinator of this site? Confirm its status
MediaUnited StatesRecruiting
Atlantic Health System
Coordinator of this site? Confirm its status
MorristownUnited StatesNot yet recruiting
Virginia Oncology Associates
Coordinator of this site? Confirm its status
Newport NewsUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center - Main Campus
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Rockefeller Outpatient Pavilion (53rd Street)
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Illinois Cancer Specialists
Coordinator of this site? Confirm its status
NilesUnited StatesRecruiting
Virginia Oncology Associates
Coordinator of this site? Confirm its status
NorfolkUnited StatesRecruiting
Illinois CancerCare-Ottawa-Fox River Cancer Center
Coordinator of this site? Confirm its status
OttawaUnited StatesRecruiting
Florida Cancer Specialists
Coordinator of this site? Confirm its status
Palm Beach GardensUnited StatesNot yet recruiting
Illinois CancerCare-Pekin
Coordinator of this site? Confirm its status
PekinUnited StatesRecruiting
Illinois CancerCare, P.C.
Coordinator of this site? Confirm its status
PeoriaUnited StatesRecruiting
Illinois CancerCare-Peru - Valley Regional Cancer Center
Coordinator of this site? Confirm its status
PeruUnited StatesRecruiting
UCLA Hematology/Oncology - Porter Ranch
Coordinator of this site? Confirm its status
Porter RanchUnited StatesRecruiting
Rocky Mountain Cancer Centers LLP
Coordinator of this site? Confirm its status
PuebloUnited StatesRecruiting
Renown Office of Clinical Research
Coordinator of this site? Confirm its status
RenoUnited StatesRecruiting
Renown Regional Medical Center
Coordinator of this site? Confirm its status
RenoUnited StatesRecruiting
Renown Health Medical Oncology
Coordinator of this site? Confirm its status
RenoUnited StatesRecruiting
Virginia Cancer Specialists, PC
Coordinator of this site? Confirm its status
RestonUnited StatesRecruiting
Maryland Oncology Hematology, P.A.
Coordinator of this site? Confirm its status
RockvilleUnited StatesRecruiting
UCSF Investigational Drugs Pharmacy
Coordinator of this site? Confirm its status
San FranciscoUnited StatesNot yet recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
Coordinator of this site? Confirm its status
San FranciscoUnited StatesNot yet recruiting
UCLA Hematology/Oncology - San Luis Obispo
Coordinator of this site? Confirm its status
San Luis ObispoUnited StatesRecruiting
UCLA Hematology/Oncology- Santa Barbara
Coordinator of this site? Confirm its status
Santa BarbaraUnited StatesRecruiting
UCLA Hematology-Oncology - Santa Monica
Coordinator of this site? Confirm its status
Santa MonicaUnited StatesRecruiting
Harborview Medical Center
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Fred Hutchinson Cancer Center
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
University of Washington Medical Center
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Florida Cancer Specialists
Coordinator of this site? Confirm its status
SebringUnited StatesNot yet recruiting
Alliance Cancer Specialists, PC
Coordinator of this site? Confirm its status
SellersvilleUnited StatesRecruiting
Maryland Oncology Hematology P.A.
Coordinator of this site? Confirm its status
Silver SpringUnited StatesRecruiting
Atlantic Health System / Overlook Medical Center
Coordinator of this site? Confirm its status
SummitUnited StatesNot yet recruiting
Rocky Mountain Cancer Centers LLP
Coordinator of this site? Confirm its status
ThorntonUnited StatesRecruiting
Virginia Oncology Associates
Coordinator of this site? Confirm its status
Virginia BeachUnited StatesRecruiting
Illinois CancerCare - Washington
Coordinator of this site? Confirm its status
WashingtonUnited StatesRecruiting
Florida Cancer Specialists
Coordinator of this site? Confirm its status
WellingtonUnited StatesNot yet recruiting
Florida Cancer Specialists
Coordinator of this site? Confirm its status
West Palm BeachUnited StatesNot yet recruiting
Virginia Cancer Specialists, PC
Coordinator of this site? Confirm its status
WoodbridgeUnited StatesRecruiting
Alliance Cancer Specialists, PC
Coordinator of this site? Confirm its status
WynnewoodUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.