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

Condition(s) studied

Investigational drug(s) / intervention(s)

PF-08634404: Participants will receive PF-08634404 intravenously.

Chemotherapy: Participants will receive PF-08634404 intravenously in combination with Chemotherapy.

Nivolumab: Participants will receive Nivolumab intravenously.

Study 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.

Eligibility

Primary outcome measure(s)

• Phase 2: Confirmed Objective response rate (ORR) using RECIST 1.1 as assessed by investigator — Approximately 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 events — Through 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 BICR — Approximately 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.

Trial sites (74)

+ 34 more sites — see the full list on the official registry below.

On this site

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