PF-08634404 + Chemotherapy for Gastroesophageal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine, PF-08634404 (experimental treatment), combined with chemotherapy for treating gastroesophageal cancer that has spread to nearby tissues or other parts of the body. Researchers aim to assess the safety and effectiveness of this combination. In the second part of the study, they will compare it to another treatment, nivolumab (a type of immunotherapy) plus chemotherapy, to determine which works better. Individuals recently diagnosed with advanced gastroesophageal cancer who have not yet received treatment might be suitable for this trial. As a Phase 2, Phase 3 trial, this study seeks to measure the treatment's effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, since participants must be treatment naïve for advanced or metastatic disease, you might need to stop certain treatments. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study showed that PF-08634404 combined with chemotherapy had a safety profile manageable for most patients. While side effects occurred, most people could handle them. However, PF-08634404 remains under investigation, and its safety is not yet fully understood.
In contrast, nivolumab, when combined with chemotherapy, has proven safe for individuals with advanced stomach and esophageal cancers. Long-term studies indicate that although some side effects exist, they are generally tolerable. These findings suggest that both treatments have undergone safety testing, but PF-08634404 requires further study to fully understand its safety with chemotherapy.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatment options for gastroesophageal cancer, which often include traditional chemotherapy regimens and drugs like Nivolumab, PF-08634404 presents a novel approach. PF-08634404 is distinguished by its innovative mechanism of action, potentially offering a more targeted treatment by specifically enhancing the immune system's ability to fight cancer cells. Researchers are excited about this treatment because it could improve patient outcomes by providing a more precise attack on cancer cells while minimizing damage to healthy tissue. This targeted approach may lead to better efficacy and potentially fewer side effects compared to existing therapies.
What evidence suggests that this trial's treatments could be effective for gastroesophageal cancer?
This trial will compare two treatment combinations for gastroesophageal cancer. Participants in one arm will receive PF-08634404 combined with chemotherapy. Research indicates that PF-08634404 might be effective when paired with chemotherapy for treating advanced cancers. Early findings from related trials suggest that this treatment could improve patient outcomes, similar to other successful cancer therapies. However, since PF-08634404 is newer, further research is needed to fully confirm its benefits.
In the other arm, participants will receive Nivolumab combined with chemotherapy. Studies have shown that Nivolumab, when used with chemotherapy, helps patients with gastroesophageal cancer live longer. Specifically, one study found that patients receiving this combination lived for a median of 21.7 months. Additionally, long-term data suggest that this treatment continues to offer a strong survival benefit even after five years.12346Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for adults (18+) with advanced or spreading stomach, esophageal, or gastroesophageal junction adenocarcinoma who haven't had treatment for advanced disease. Participants must be in good physical health, have healthy organs, HER-2 negative and PD-L1 positive tumors. Certain medical conditions like recent major surgery or active autoimmune diseases exclude participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PF-08634404 in combination with chemotherapy in repeated cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue to receive study medication in an open-label extension
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
- PF-08634404
Trial Overview
The study tests a new medicine called PF-08634404 combined with chemotherapy versus the approved drug nivolumab plus chemotherapy in people with advanced gastroesophageal cancers. The goal is to see which combination works better and how safe they are.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
PF-08634404 + Chemotherapy
PF-08634404 + Chemotherapy
Nivolumab + Chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
Safety and efficacy of first-line nivolumab plus chemotherapy ...
At a median follow-up of 14.0 months, the median progression-free survival (PFS) and overall survival (OS) were 7.9 and 21.7 months, ...
5-year follow-up results from CheckMate 649
Nivolumab plus chemotherapy continued to demonstrate long-term survival benefit and acceptable safety after 5 years of follow-up, reinforcing ...
First results of overall survival (OS) from CheckMate 577.
OS rates at 3 and 5 years with nivolumab vs placebo were 57% vs 50% and 46% vs 41%, respectively. OS subgroup analyses will be presented.
4.
onclive.com
onclive.com/view/dr-janjigian-on-5-year-data-with-nivolumab-plus-chemotherapy-in-gastric-gej-esophageal-cancerDr Janjigian on 5-Year Data With Nivolumab Plus ...
The 5-year data confirm a sustained survival benefit with nivolumab plus chemotherapy across all randomized patients and across PD-L1 combined ...
5.
targetedonc.com
targetedonc.com/view/5-year-update-sustains-nivolumab-chemo-efficacy-in-frontline-gastric-gej-esophageal-cancer5-Year Update Sustains Nivolumab/Chemo Efficacy in ...
The 5-year OS rates were 16% and 6%, respectively. OS and progression-free survival (PFS) in this subgroup were the primary end points of the ...
6.
gastroenterologyadvisor.com
gastroenterologyadvisor.com/news/advanced-gastric-ge-junction-cancer-nivolumab-ups-os-pfs-but-ae-risk-is-high/Nivolumab Improves OS, PFS in Patients with Advanced ...
Nivolumab monotherapy (4 studies, 1176 patients) was associated with significant improvement in OS (MD, 2.52; 95% CI, 0.81-4.23), as was the OS ...
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