PF-08634404 plus chemotherapy for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2/3 study first explores safety and response of PF-08634404 given with standard chemotherapy, then moves to a randomized comparison against the approved regimen of nivolumab plus chemotherapy. Eligible participants are adults with untreated locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma who are HER2-negative and PD-L1-positive with good performance status and adequate organ function. Treatment is given in repeated cycles and outcomes include safety, tumor response, and comparative effectiveness. The second part directly compares the combination to nivolumab plus chemotherapy to see which approach provides better disease control.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• UCLA Hematology/Oncology - Atascadero
  Atascadero, California, United States Recruiting
• UCLA Hematology/Oncology - Burbank
  Burbank, California, United States Recruiting
• UCLA Hematology/Oncology - Encino
  Encino, California, United States Recruiting
• UCLA Hematology/Oncology - Marina del Rey
  Marina del Rey, California, United States Recruiting
• UCLA Hematology/Oncology - Porter Ranch
  Porter Ranch, California, United States Recruiting
• UCLA Hematology/Oncology - San Luis Obispo
  San Luis Obispo, California, United States Recruiting

+52 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.