Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

Summary

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.

Official Title

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

Keywords

Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma, Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma, gastric cancer, Stomach Neoplasms, Adenocarcinoma Of Esophagus, Drug Therapy, Nivolumab, Chemotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Hematology/Oncology - Burbank accepting new patients
    Burbank California 91505 United States
  • UCLA Hematology/Oncology - Encino accepting new patients
    Encino California 91436 United States
  • UCLA Hematology/Oncology - Marina del Rey accepting new patients
    Marina del Rey California 90292 United States
  • UCLA Hematology/Oncology - Porter Ranch accepting new patients
    Porter Ranch California 91326 United States
  • UCLA Hematology/Oncology - Santa Monica accepting new patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT07392892
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 840 study participants
Last Updated