PF-08634404 + Chemotherapy for Endometrial 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, to determine if it benefits women with a specific type of advanced or recurrent endometrial cancer more than an existing treatment, pembrolizumab (an immunotherapy drug), plus chemotherapy. Endometrial cancer occurs in the lining of the uterus, and this trial focuses on cancers proficient in mismatch repair (pMMR), meaning the cancer cells can correct certain genetic mistakes, making them harder for the immune system to attack. Women with pMMR endometrial cancer that has spread or recurred after initial treatment, who are in good health and haven't had extensive chemotherapy, might be suitable candidates for this trial. Researchers will randomly assign participants to receive either the new treatment or the existing one to compare their effectiveness. Regular health checks and cancer response tests will monitor progress and safety. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the study team to understand any potential interactions or requirements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that PF-08634404 remains under study, but early results suggest it might be safe. One study found that patients could use this treatment for up to two years, with generally manageable side effects. However, this treatment is not yet approved, and its complete safety continues to be researched.
In contrast, pembrolizumab, which this trial compares, is already approved for use with chemotherapy in some cancer patients. Studies have shown that it has a safety profile with known side effects, such as fatigue and nausea, along with some rare but serious effects.
Ongoing studies carefully monitor both treatments for safety. Participants in any clinical trial like this one receive close monitoring for any reactions or side effects.12345Why do researchers think this study treatment might be promising?
Researchers are excited about PF-08634404 for endometrial cancer because it introduces a novel mechanism of action compared to current treatments like chemotherapy and immunotherapy alone. Unlike standard care options, PF-08634404 is combined with chemotherapy, potentially enhancing the overall effectiveness by targeting cancer cells more precisely. Additionally, this treatment includes a maintenance phase with PF-08634404, which might offer longer-lasting protection against cancer recurrence. Meanwhile, Pembrolizumab, already known for boosting the immune system to fight cancer, is being evaluated in combination with chemotherapy to assess its potential for improved outcomes.
What evidence suggests that this trial's treatments could be effective for advanced or recurrent endometrial cancer?
Research has shown that PF-08634404, a new medicine, appears promising when combined with chemotherapy. Early studies indicate that it can improve treatment outcomes for certain cancers, such as endometrial cancer, by targeting specific proteins that promote tumor growth. In this trial, some participants will receive PF-08634404 with chemotherapy, followed by PF-08634404 maintenance therapy. Conversely, pembrolizumab, when used with chemotherapy, has significantly extended the time during which the disease does not worsen in patients with advanced endometrial cancer. This combination reduces the risk of cancer progression by about 70% compared to chemotherapy alone. Participants in another arm of this trial will receive pembrolizumab with chemotherapy, followed by pembrolizumab maintenance therapy. Both treatments are under study to determine which is more effective for advanced or recurrent endometrial cancer.12367
Who 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 adult women (18+) with advanced or recurrent endometrial cancer where the DNA repair system works normally (pMMR). Participants must not be pregnant, should have good organ function, and cannot have had recent chemotherapy except after surgery if it was over 6 months ago.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 plus chemotherapy or pembrolizumab plus chemotherapy, followed by maintenance therapy for up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- PF-08634404
- Standard of Care Chemotherapy
Trial Overview
The study compares a new medicine called PF-08634404 plus chemotherapy to pembrolizumab plus chemotherapy. After initial treatment, participants continue on their assigned medicine alone for up to two years. Treatments are given by IV in cycles, and group assignment is random.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
PF-08634404 plus Chemotherapy, followed by PF-08634404 maintenance therapy
Pembrolizumab plus Chemotherapy, followed by Pembrolizumab maintenance therapy
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
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
GOG Foundation
Collaborator
Citations
1.
pfizer.com
pfizer.com/news/press-release/press-release-detail/pfizer-showcases-oncology-innovation-and-next-generationPfizer Showcases Oncology Innovation and Next ...
Additional efficacy and safety outcomes by stratified. Updated Phase 2 data for PF‐08634404 (PF'4404), a novel bispecific antibody targeting PD ...
A phase 2 study evaluating SSGJ-707 (PF-08634404) ...
SSGJ-707 has demonstrated promising efficacy and manageable safety alone and in combination with chemo in phase 2 studies in solid tumors.
PF-08634404 / 3SBio, Pfizer
PF-08634404, a. Endometrial Cancer • Oncology and patient-reported outcomes.
Pfizer Showcases Oncology Innovation and Next- ...
Updated Phase 2 data for PF‑08634404 (PF'4404), a novel bispecific antibody targeting PD-1 and VEGF, as monotherapy in first-line PD-L1-expressing NSCLC. PF ...
Molecular profile-based adjuvant treatment for women with ...
Individualised adjuvant treatment by molecular integrated risk profile is safe and effective for patients with high-intermediate risk endometrial cancer; it ...
NCT07578649 | Symbiotic-GYN-18: A Study to Learn ...
This study is being conducted to assess whether the study medicine PF 08634404, given in combination with chemotherapy, improves outcomes compared with another ...
PD-1 x VEGF Bispecific Antibody
PF-08634404 is an investigational compound. Its safety and efficacy have not been established.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.