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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • PF-08634404
  • Chemotherapy
  • Nivolumab

Treatment groups

840 Participants
are divided into 3 treatment groups

Sponsors and collaborators