Clinical trial for Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or...
Official title Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer
ClinicalTrials.gov ID: NCT07392892
What this study is testing
What is PF-08634404?
PF-08634404 is an investigational intravenous medicine being studied for the treatment of untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how safe and effective PF-08634404 is when combined with chemotherapy, and later to compare it with the standard treatment nivolumab plus chemotherapy.
- Who it's for
- Adults 18 or older with untreated advanced or metastatic stomach, gastroesophageal junction, or esophageal adenocarcinoma who are in good health.
- What's involved
- Participants receive PF-08634404 together with chemotherapy in repeated cycles, and will have regular medical visits and tests to monitor safety and response.
- Time commitment
- The study lasts several months, with multiple treatment cycles and scheduled visits for monitoring and testing.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Atascadero, California, United States
- Burbank, California, United States
- Encino, California, United States
- Marina del Rey, California, United States
- Porter Ranch, California, United States
- San Luis Obispo, California, United States
- Santa Barbara, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- Boulder, Colorado, United States
- Centennial, Colorado, United States
- Colorado Springs, Colorado, United States
- Denver, Colorado, United States
- Englewood, Colorado, United States
- Lakewood, Colorado, United States
- Littleton, Colorado, United States
- Lone Tree, Colorado, United States
- Longmont, Colorado, United States
- Pueblo, Colorado, United States
- Thornton, Colorado, United States
+ 58 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atascadero, California, United States; Burbank, California, United States; Encino, California, United States; Marina del Rey, California, United States; Porter Ranch, California, United States; San Luis Obispo, California, United States and 72 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.