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
- Diseases
- Gastric and esophageal cancer
- 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
Sites (99)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre - Verspeeten Family Cancer Centre Coordinator of this site? Confirm its status | London | Canada | Not yet recruiting |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Complejo Hospitalario Universitario de Ourense Coordinator of this site? Confirm its status | Ourense | Spain | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Aichi Cancer Center Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Pan American Center for Oncology Trials, LLC - Bayamón Office Coordinator of this site? Confirm its status | Bayamón | Puerto Rico | Recruiting |
| Pan American Center for Oncology Trials, LLC - Manati Office Coordinator of this site? Confirm its status | Manati | Puerto Rico | Recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Maryland Oncology Hematology P.A. Coordinator of this site? Confirm its status | Annapolis | United States | Recruiting |
| Virginia Cancer Specialists, PC Coordinator of this site? Confirm its status | Arlington | United States | Recruiting |
| Illinois Cancer Specialists Coordinator of this site? Confirm its status | Arlington Heights | United States | Recruiting |
| UCLA Hematology/Oncology - Atascadero Coordinator of this site? Confirm its status | Atascadero | United States | Recruiting |
| Rocky Mountain Cancer Centers,LLP Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Alliance Cancer Specialists, PC Coordinator of this site? Confirm its status | Bensalem | United States | Recruiting |
| Maryland Oncology Hematology P.A. Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| Illinois CancerCare-Bloomington Coordinator of this site? Confirm its status | Bloomington | United States | Recruiting |
| Rocky Mountain Cancer Centers LLP Coordinator of this site? Confirm its status | Boulder | United States | Recruiting |
| Maryland Oncology Hematology P.A. Coordinator of this site? Confirm its status | Brandywine | United States | Recruiting |
| UCLA Hematology/Oncology - Burbank Coordinator of this site? Confirm its status | Burbank | United States | Recruiting |
| Rocky Mountain Cancer Centers LLP Coordinator of this site? Confirm its status | Centennial | United States | Recruiting |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Chesapeake | United States | Recruiting |
| Illinois Cancer Specialists Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Oncology Hematology Care Clinical Trials LLC Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Rocky Mountain Cancer Centers LLP Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Maryland Oncology Hematology P.A. Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Daytona Beach | United States | Not yet recruiting |
| Rocky Mountain Cancer Centers, LLP Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Alliance Cancer Specialists, PC Coordinator of this site? Confirm its status | Doylestown | United States | Recruiting |
| UCLA Hematology/Oncology - Encino Coordinator of this site? Confirm its status | Encino | United States | Recruiting |
| Rocky Mountain Cancer Centers LLP Coordinator of this site? Confirm its status | Englewood | United States | Recruiting |
| Virginia Cancer Specialists PC Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Oncology Hematology Care Clinical Trials, LLC Coordinator of this site? Confirm its status | Fairfield | United States | Recruiting |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Fleming Island | United States | Not yet recruiting |
| Illinois CancerCare-Galesburg Coordinator of this site? Confirm its status | Galesburg | United States | Recruiting |
| Maryland Oncology Hematology P.A. Coordinator of this site? Confirm its status | Germantown | United States | Recruiting |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Hampton | United States | Recruiting |
| Alliance Cancer Specialists, PC Coordinator of this site? Confirm its status | Horsham | United States | Recruiting |
| US Oncology Investigational Products Center (IPC) Coordinator of this site? Confirm its status | Irving | United States | Recruiting |
| Rocky Mountain Cancer Centers LLP Coordinator of this site? Confirm its status | Lakewood | United States | Recruiting |
| Alliance Cancer Specialists, PC Coordinator of this site? Confirm its status | Langhorne | United States | Recruiting |
| Maryland Oncology Hematology P.A. Coordinator of this site? Confirm its status | Largo | United States | Recruiting |
| Rocky Mountain Cancer Centers LLP Coordinator of this site? Confirm its status | Littleton | United States | Recruiting |
| Rocky Mountain Cancer Centers,LLP Coordinator of this site? Confirm its status | Lone Tree | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center Pharmacy (IMP ship to address) Coordinator of this site? Confirm its status | Long Island City | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center Pharmacy (IMP storage location) Coordinator of this site? Confirm its status | Long Island City | United States | Recruiting |
| Rocky Mountain Cancer Centers LLP Coordinator of this site? Confirm its status | Longmont | United States | Recruiting |
| Virginia Cancer Specialists, PC Coordinator of this site? Confirm its status | Manassas | United States | Recruiting |
| UCLA Hematology/Oncology - Marina del Rey Coordinator of this site? Confirm its status | Marina del Rey | United States | Recruiting |
| Alliance Cancer Specialists, PC Coordinator of this site? Confirm its status | Media | United States | Recruiting |
| Atlantic Health System Coordinator of this site? Confirm its status | Morristown | United States | Not yet recruiting |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Newport News | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center - Main Campus Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Rockefeller Outpatient Pavilion (53rd Street) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Illinois Cancer Specialists Coordinator of this site? Confirm its status | Niles | United States | Recruiting |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Norfolk | United States | Recruiting |
| Illinois CancerCare-Ottawa-Fox River Cancer Center Coordinator of this site? Confirm its status | Ottawa | United States | Recruiting |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Palm Beach Gardens | United States | Not yet recruiting |
| Illinois CancerCare-Pekin Coordinator of this site? Confirm its status | Pekin | United States | Recruiting |
| Illinois CancerCare, P.C. Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Illinois CancerCare-Peru - Valley Regional Cancer Center Coordinator of this site? Confirm its status | Peru | United States | Recruiting |
| UCLA Hematology/Oncology - Porter Ranch Coordinator of this site? Confirm its status | Porter Ranch | United States | Recruiting |
| Rocky Mountain Cancer Centers LLP Coordinator of this site? Confirm its status | Pueblo | United States | Recruiting |
| Renown Office of Clinical Research Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Renown Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Renown Health Medical Oncology Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Virginia Cancer Specialists, PC Coordinator of this site? Confirm its status | Reston | United States | Recruiting |
| Maryland Oncology Hematology, P.A. Coordinator of this site? Confirm its status | Rockville | United States | Recruiting |
| UCSF Investigational Drugs Pharmacy Coordinator of this site? Confirm its status | San Francisco | United States | Not yet recruiting |
| UCSF Helen Diller Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | San Francisco | United States | Not yet recruiting |
| UCLA Hematology/Oncology - San Luis Obispo Coordinator of this site? Confirm its status | San Luis Obispo | United States | Recruiting |
| UCLA Hematology/Oncology- Santa Barbara Coordinator of this site? Confirm its status | Santa Barbara | United States | Recruiting |
| UCLA Hematology-Oncology - Santa Monica Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
| Harborview Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Sebring | United States | Not yet recruiting |
| Alliance Cancer Specialists, PC Coordinator of this site? Confirm its status | Sellersville | United States | Recruiting |
| Maryland Oncology Hematology P.A. Coordinator of this site? Confirm its status | Silver Spring | United States | Recruiting |
| Atlantic Health System / Overlook Medical Center Coordinator of this site? Confirm its status | Summit | United States | Not yet recruiting |
| Rocky Mountain Cancer Centers LLP Coordinator of this site? Confirm its status | Thornton | United States | Recruiting |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Virginia Beach | United States | Recruiting |
| Illinois CancerCare - Washington Coordinator of this site? Confirm its status | Washington | United States | Recruiting |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | Wellington | United States | Not yet recruiting |
| Florida Cancer Specialists Coordinator of this site? Confirm its status | West Palm Beach | United States | Not yet recruiting |
| Virginia Cancer Specialists, PC Coordinator of this site? Confirm its status | Woodbridge | United States | Recruiting |
| Alliance Cancer Specialists, PC Coordinator of this site? Confirm its status | Wynnewood | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.