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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Phase 2 is open-label, whereas Phase 3 is double-blind, randomized design

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 2 Portion 		PF-08634404 + Chemotherapy
  • Biological: PF-08634404
    Participants will receive PF-08634404 intravenously.
    Other names:
    • SSGJ-707
  • Drug: Chemotherapy
    Participants will receive PF-08634404 intravenously in combination with Chemotherapy.
Experimental
Phase 3: Arm A 		PF-08634404 + Chemotherapy
  • Biological: PF-08634404
    Participants will receive PF-08634404 intravenously.
    Other names:
    • SSGJ-707
  • Drug: Chemotherapy
    Participants will receive PF-08634404 intravenously in combination with Chemotherapy.
Active Comparator
Phase 3: Arm B 		Nivolumab + Chemotherapy
  • Drug: Chemotherapy
    Participants will receive PF-08634404 intravenously in combination with Chemotherapy.
  • Biological: Nivolumab
    Participants will receive Nivolumab intravenously.

Recruiting Locations

Rocky Mountain Cancer Centers, LLP
Aurora, Colorado 80012

Rocky Mountain Cancer Centers, LLP
Boulder, Colorado 80303

Rocky Mountain Cancer Centers, LLP
Centennial, Colorado 80112

Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado 80907

Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado 80923

Rocky Mountain Cancer Centers, LLP
Denver, Colorado 80218

Rocky Mountain Cancer Centers, LLP
Denver, Colorado 80220

Rocky Mountain Cancer Centers, LLP
Englewood, Colorado 80113

Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado 80228

Rocky Mountain Cancer Centers, LLP
Littleton, Colorado 80120

Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado 80124

Rocky Mountain Cancer Centers, LLP
Longmont, Colorado 80504

Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado 81003

Rocky Mountain Cancer Centers, LLP
Thornton, Colorado 80260

Illinois Cancer Specialists
Arlington Heights, Illinois 60005

Illinois CancerCare - Bloomington
Bloomington, Illinois 61704

Illinois Cancer Specialists
Chicago, Illinois 60631

Illinois CancerCare - Galesburg
Galesburg, Illinois 61401

Illinois Cancer Specialists
Niles, Illinois 60714

Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa, Illinois 61350

Illinois CancerCare-Pekin
Pekin, Illinois 61554

Illinois CancerCare, P.C.
Peoria, Illinois 61615

Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru, Illinois 61354

Illinois CancerCare-Washington
Washington, Illinois 61571

Maryland Oncology Hematology, P.A.
Annapolis, Maryland 21401

Maryland Oncology Hematology, P.A.
Bethesda, Maryland 20817

Maryland Oncology Hematology, P.A.
Brandywine, Maryland 20613

Maryland Oncology Hematology, P.A.
Columbia, Maryland 21044

Maryland Oncology Hematology, P.A.
Germantown, Maryland 20876

Maryland Oncology Hematology, P.A.
Largo, Maryland 20774

Maryland Oncology Hematology, P.A.
Rockville, Maryland 20850

Maryland Oncology Hematology, P.A.
Silver Spring, Maryland 20904

Renown Health Medical Oncology
Reno, Nevada 89502

Renown Office of Clinical Research
Reno, Nevada 89502

Renown Regional Medical Center
Reno, Nevada 89502

Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio 45211

Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio 45242

Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio 45245

Oncology Hematology Care Clinical Trials, LLC
Fairfield, Ohio 45014

Alliance Cancer Specialists, PC
Bensalem, Pennsylvania 19020

Alliance Cancer Specialists, PC
Doylestown, Pennsylvania 18901

Alliance Cancer Specialists, PC
Langhorne, Pennsylvania 19047

Alliance Cancer Specialists, PC
Media, Pennsylvania 19063

Alliance Cancer Specialists, PC
Sellersville, Pennsylvania 18960

Alliance Cancer Specialists, PC
Wynnewood, Pennsylvania 19096

US Oncology Investigational Products Center (IPC)
Irving, Texas 75063

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com