Clinical Trial for Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma, Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma.

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

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

Sex

Male or Female

Age

18+ years

Healthy participants

Visit ClinicalTrials.gov for more information

Eligibility 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

Study overview

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.

View locations for this study

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Miles

0500

Nearest Locations found

58 sites found

Alliance Cancer Specialists, PC

Bensalem, Pennsylvania, United States, 19020

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Alliance Cancer Specialists, PC

Doylestown, Pennsylvania, United States, 18901

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Alliance Cancer Specialists, PC

Langhorne, Pennsylvania, United States, 19047

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Alliance Cancer Specialists, PC

Media, Pennsylvania, United States, 19063

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Alliance Cancer Specialists, PC

Sellersville, Pennsylvania, United States, 18960

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Alliance Cancer Specialists, PC

Wynnewood, Pennsylvania, United States, 19096

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Illinois Cancer Specialists

Arlington Heights, Illinois, United States, 60005

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Illinois Cancer Specialists

Chicago, Illinois, United States, 60631

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Illinois Cancer Specialists

Niles, Illinois, United States, 60714

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Illinois CancerCare - Bloomington

Bloomington, Illinois, United States, 61704

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Illinois CancerCare - Galesburg

Galesburg, Illinois, United States, 61401

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Illinois CancerCare, P.C.

Peoria, Illinois, United States, 61615

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Illinois CancerCare-Ottawa-Fox River Cancer Center

Ottawa, Illinois, United States, 61350

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Illinois CancerCare-Pekin

Pekin, Illinois, United States, 61554

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Illinois CancerCare-Peru - Valley Regional Cancer Center

Peru, Illinois, United States, 61354

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Illinois CancerCare-Washington

Washington, Illinois, United States, 61571

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Maryland Oncology Hematology, P.A.

Annapolis, Maryland, United States, 21401

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Maryland Oncology Hematology, P.A.

Bethesda, Maryland, United States, 20817

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Maryland Oncology Hematology, P.A.

Brandywine, Maryland, United States, 20613

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Maryland Oncology Hematology, P.A.

Columbia, Maryland, United States, 21044

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Maryland Oncology Hematology, P.A.

Germantown, Maryland, United States, 20876

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Maryland Oncology Hematology, P.A.

Largo, Maryland, United States, 20774

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Maryland Oncology Hematology, P.A.

Rockville, Maryland, United States, 20850

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Maryland Oncology Hematology, P.A.

Silver Spring, Maryland, United States, 20904

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Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States, 45211

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Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States, 45242

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Oncology Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States, 45245

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Oncology Hematology Care Clinical Trials, LLC

Fairfield, Ohio, United States, 45014

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Renown Health Medical Oncology

Reno, Nevada, United States, 89502

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Renown Office of Clinical Research

Reno, Nevada, United States, 89502

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Renown Regional Medical Center

Reno, Nevada, United States, 89502

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