Trials / Recruiting
RecruitingNCT07392892
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
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 840 (estimated)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma
- Metastatic Gastric Cancer
- Gastroesophageal Junction Cancer
- Esophageal Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PF-08634404 | Participants will receive PF-08634404 intravenously. |
| DRUG | Chemotherapy | Participants will receive PF-08634404 intravenously in combination with Chemotherapy. |
| BIOLOGICAL | Nivolumab | Participants will receive Nivolumab intravenously. |
Timeline
- Start date
- 2026-04-28
- Primary completion
- 2031-07-22
- Completion
- 2032-07-21
- First posted
- 2026-02-06
- Last updated
- 2026-04-13
Locations
58 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07392892. Inclusion in this directory is not an endorsement.