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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

StatusRecruiting
PhasePhase 2/3
SponsorPfizer
Started
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Record History

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  1. Primary completion moved earlier from Jan 15, 2032 to Jul 22, 2031
    • Study completion moved earlier from Jan 14, 2033 to Jul 21, 2032
  2. Study sites: 100 to 102
  3. Primary completion pushed from Jul 22, 2031 to Jan 15, 2032 Show 4 more changesShow less
    • Trial sites expanded: 74 → 100 locations
    • Study completion pushed from Jul 21, 2032 to Jan 14, 2033
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 2 of 19 entries
  4. Trial sites expanded: 70 → 74 locationsv6
  5. Study sites: 69 to 70v5
  6. Study sites: 71 to 69v4
  7. Trial sites expanded: 58 → 71 locations
    • Start date changed from estimate of Apr 28, 2026 to May 14, 2026
    • Study title expanded, about 1 word
    v3
  8. Recruitment opened
    • Start date: Mar 2, 2026 to Apr 28, 2026
    • Trial sites expanded: 0 → 58 locations
    • Eligibility criteria expanded, about 14 words
    v2
  9. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
436 trials monitored
See 32 trials at risk
Gastric Cancer
1,278 trials monitored
See 63 trials at risk
Esophageal Cancer
1,049 trials monitored
See 54 trials at risk
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.
Trial Details
NCT Number NCT07392892
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma, Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma
Related terms Adenocarcinoma Of Esophagus, Stomach Neoplasms
Enrollment 840 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov