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

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

Phase2; Phase3 Interventional Pfizer · NCT07392892

This trial will test whether adding the experimental medicine PF-08634404 to chemotherapy helps adults with newly diagnosed, locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma compared with nivolumab plus chemotherapy.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment840 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsnivolumab, chemotherapy
Locations58 sites (Aurora, Colorado and 57 other locations)
Trial IDNCT07392892 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with untreated, locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma who are HER2-negative, PD-L1-positive, ECOG 0–1, have adequate organ function, and have not received prior systemic therapy for advanced disease.

Not a fit: Patients with HER2-positive or PD-L1‑negative tumors, active central nervous system metastases, recent major surgery, high bleeding risk, prior organ transplant, or prior systemic therapy for advanced disease are unlikely to be eligible or to benefit from this regimen.

Why it matters

Potential benefit: If successful, the combination could offer improved tumor control and survival for patients compared with the current nivolumab-plus-chemotherapy option.

How similar studies have performed: Combinations of immune-targeting drugs with chemotherapy (for example, nivolumab plus chemo) have improved outcomes in this setting, but PF-08634404 is a new agent with limited prior data and remains experimental.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Aurora, Colorado and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal AdenocarcinomaMetastatic Gastric CancerGastroesophageal Junction CancerEsophageal Adenocarcinomagastric cancergastroesophageal junction canceresophageal adenocarcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.