Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer
a study on Esophageal Cancer Stomach Cancer Gastroesophageal Junction Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedstudy 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
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Providing your contact details does not obligate you to participate in the research.
Thank you!
The study team should get back to you in a few business days.