No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
840 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for
This trial is looking for adults with advanced gastroesophageal cancer who have not been treated for this stage of the disease. Participants will receive a new medicine called PF-08634404 along with standard chemotherapy.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have been diagnosed with advanced or metastatic gastric or esophageal cancer.
I have not received any prior treatment for my advanced cancer.
I am in good physical shape with healthy organs as shown by medical tests.
I have a performance status of 0-1.
I have HER-2 negative status.
I have PD-L1 positive status.
You may not be able to join if
I have active brain or spinal cord metastases.
I have a significant risk of bleeding or fistula.
I have had major surgery or severe trauma in the last 4 weeks.
I have had an organ transplant.
I have had severe bleeding events in the last 28 days.
I have significant heart disease or other serious health issues in the last 6 months.
I have active autoimmune diseases needing systemic treatment in the past 2 years.
I have evidence of non-infectious lung disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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, …
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.
Trial Locations
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Facility
City
State
Country
Status
Eligibility Criteria
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 metastati…
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
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