840 Participants NeededMy employer runs this trial

PF-08634404 + Chemotherapy for Gastroesophageal Cancer

Recruiting at 75 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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.12345

Why 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.12346

Who Is on the Research Team?

PC

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

I have a confirmed diagnosis of stomach or esophageal adenocarcinoma.
My liver and kidney functions are normal.
My cancer has spread locally or to other parts of my body.
See 4 more

Exclusion Criteria

History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
I have had serious heart or other major health problems in the past 6 months.
Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-08634404 in combination with chemotherapy in repeated cycles

Approximately 21 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Through 90 days after the last study intervention

Extension

Participants may continue to receive study medication in an open-label extension

Long-term

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

Group I: Phase 3: Arm AExperimental Treatment2 Interventions
Group II: Phase 2 PortionExperimental Treatment2 Interventions
Group III: Phase 3: Arm BActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

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.

Dr 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-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 ...

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 ...