Back to search results

PF-08634404 with Chemotherapy for Gastroesophageal Cancer

This study is looking into a new medicine called PF-08634404. Researchers want to see how well it works when given with chemotherapy to people who have gastroesophageal cancer that has spread to nearby tissues (locally advanced) or to other parts of the body (metastatic). You might be able to join if you are 18 or older, have this type of cancer, and have not yet received treatment for your advanced or metastatic disease. The study will first check the safety of PF-08634404 combined with chemotherapy and how well people respond to it. Success will be measured by how many people respond to the treatment and how long they live without their cancer getting worse. The study is currently unclear on its recruitment status and plans to enroll 840 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 840 participants, but the phase is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events for up to 90 days after their last study intervention, and for approximately 4 years to assess progression-free survival and objective response rate.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07392892

Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Pfizer
~840 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:PF-08634404ChemotherapyNivolumab

At a glance

Recruiting sites
69 of 74 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 2: Confirmed Objective response rate (ORR) using RECIST 1.1 as assessed by investigator
Measured over Approximately 4 years
+3 more outcomes measured

Conditions

Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma
Metastatic Gastric Cancer
Gastroesophageal Junction Cancer
Esophageal Adenocarcinoma

Explore related trials

Esophageal AdenocarcinomaGastric CarcinomaGastroesophageal Junction AdenocarcinomaProgrammed Cell Death 1 Ligand 1

Where it's being run

74 sites across 20 states
Colorado14
Illinois10
Virginia10
Maryland8
Pennsylvania7
Ohio4
Nevada3
Washington3

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Phase 2: Confirmed Objective response rate (ORR) using RECIST 1.1 as assessed by investigatorApproximately 4 years

    Confirmed ORR by investigator is defined as the proportion of participants with confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1 as assessed by investigator.

  • Phase 2: Number of participants with treatment-emergent adverse eventsThrough 90 days after the last study intervention; Approximately 4 years

    Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.

  • Phase 3: Progression Free Survival (PFS) using RECIST 1.1 as assessed by BICRApproximately 4 years

    PFS by BICR is defined as the time from the date of randomization to the date of first documented disease progression per RECIST 1.1 as assessed by BICR, or death due to any cause, whichever occurs first.

  • Phase 3: Overall Survival (OS)Approximately 4 years

    OS is defined as the time from the date of randomization to the date of death due to any cause.