Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer
Recruiting now · Phase 2/Phase 3
Conditions studied: Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma, Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT07392892
- Run by
- Pfizer
- People needed
- 840
- Starts
- 2026-05-14
- Expected to finish
- 2032-07-21
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Rocky Mountain Cancer Centers, LLP — Boulder, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Centennial, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Colorado Springs, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Colorado Springs, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Englewood, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Lakewood, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Littleton, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Longmont, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Pueblo, Colorado, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Thornton, Colorado, United States (enrolling)
- Illinois Cancer Specialists — Arlington Heights, Illinois, United States (enrolling)
- Illinois CancerCare - Bloomington — Bloomington, Illinois, United States (enrolling)
- Illinois Cancer Specialists — Chicago, Illinois, United States (enrolling)
- Illinois CancerCare - Galesburg — Galesburg, Illinois, United States (enrolling)
- Illinois Cancer Specialists — Niles, Illinois, United States (enrolling)
- Illinois CancerCare-Ottawa-Fox River Cancer Center — Ottawa, Illinois, United States (enrolling)
- Illinois CancerCare-Pekin — Pekin, Illinois, United States (enrolling)
- Illinois CancerCare, P.C. — Peoria, Illinois, United States (enrolling)
- Illinois CancerCare-Peru - Valley Regional Cancer Center — Peru, Illinois, United States (enrolling)
- Illinois CancerCare-Washington — Washington, Illinois, United States (enrolling)
- Maryland Oncology Hematology, P.A. — Annapolis, Maryland, United States (enrolling)
- Rocky Mountain Cancer Centers, LLP — Aurora, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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