PF-08634404 + Enfortumab Vedotin for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new medicine, PF-08634404 (experimental treatment), for adults with a specific type of bladder cancer that has spread locally or to other parts of the body. The goal is to determine if this medicine is safe and effective in treating the cancer. The trial includes two groups: one for patients who have tried other treatments and another for those who have not. Participants must have this type of bladder cancer to join. The treatment involves administering the medicine through an IV, and doctors will closely monitor the cancer's response. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
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 this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found enfortumab vedotin, used for treating advanced bladder cancer, to be generally safe. Most patients tolerated it well, and side effects were usually not serious. Research shows that common side effects included tiredness and skin reactions, often mild to moderate.
For PF-08634404, less information is available because it remains under testing. In these early stages, the main goal is to assess the treatment's safety. Safety is a key focus, but more data is still being collected.
Overall, while enfortumab vedotin has been shown to be safe for many patients, researchers continue to study PF-08634404 to ensure it is also well-tolerated.12345Why are researchers excited about this trial's treatments?
Researchers are excited about PF-08634404 and enfortumab vedotin for bladder cancer because they offer new ways to tackle the disease. Enfortumab vedotin is an antibody-drug conjugate that specifically targets and delivers a potent chemotherapy agent directly to cancer cells, potentially reducing side effects compared to traditional chemotherapy. PF-08634404, when used alone or in combination, aims to enhance immune response and attack cancer cells more effectively. These treatments have the potential to provide new hope for patients with both previously treated and untreated bladder cancer, possibly offering better outcomes than current standard options like chemotherapy and immunotherapy.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
Research has shown that enfortumab vedotin, when used alone, has potential in treating advanced bladder cancer. In real-world studies, patients using enfortumab vedotin lived for an average of 7.2 to 11 months. This treatment targets a protein called Nectin-4 on cancer cells, aiding the body's fight against them.
In this trial, participants in Cohort A will receive PF-08634404 as monotherapy, while Cohort B will receive a combination of PF-08634404 and enfortumab vedotin. Early signs suggest this combination could be effective. Enfortumab vedotin has already demonstrated significant benefits when used with other drugs, improving survival rates in some cases. This combination therapy might enhance the treatment response by attacking the cancer in different ways.45678Who 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 metastatic urothelial (bladder) cancer. Participants must have measurable disease, good organ function, and be able to follow study rules. People with active autoimmune diseases, brain involvement, recent other cancers, or who are pregnant/breastfeeding cannot join.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 alone or in combination with enfortumab vedotin through IV infusion. Treatment continues as long as it is effective and side effects are manageable.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including scans to monitor cancer progression.
Open-label extension (optional)
Participants may continue treatment if the cancer worsens but the treatment is still helping and side effects are manageable, with agreement from the doctor and sponsor.
What Are the Treatments Tested in This Trial?
Interventions
- Enfortumab Vedotin
- PF-08634404
Trial Overview
The study tests a new drug called PF-08634404 alone in people who've had prior treatment and together with enfortumab vedotin in those who haven't been treated before. Both drugs are given by IV infusion. The goal is to check safety and how well the treatments work.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin
Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy.
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
Astellas Pharma Inc
Industry Sponsor
Tadaaki Taniguchi
Astellas Pharma Inc
Chief Medical Officer since 2023
MD, PhD
Naoki Okamura
Astellas Pharma Inc
Chief Executive Officer since 2023
University of Tokyo, Faculty of Pharmacy
Citations
Efficacy and safety of the first-line systemic treatments in ...
The prognosis of patients with advanced-stage urothelial carcinoma (aUC) is poor, and the 5-year survival rate is only 10% (3). In the 1990s, a ...
Clinical Trial for Urothelial Cancer, Advanced/Metastatic ...
This study is being done to learn more about a new medicine called PF-08634404. It is for adults with a type of bladder cancer called locally advanced or ...
PF-08634404 + Enfortumab Vedotin for Bladder Cancer
Treatment continues as long as it is effective and side effects are manageable. Up to approximately 3 years. Regular visits for treatment and ...
4.
oncologynewscentral.com
oncologynewscentral.com/bladder-cancer/long-term-benefit-with-adjuvant-nivolumab-for-bladder-cancer-beats-expectationsNivolumab Shows Long-Term Benefit in Bladder Cancer Trial
Adjuvant nivolumab nearly doubled five-year disease-free survival in patients with high-risk muscle-invasive urothelial carcinoma.
Pfizer Showcases Oncology Innovation and Next- ...
Late-breaking presentation of progression-free survival (PFS) and overall survival (OS) data from Cohort 3 of the BREAKWATER* trial evaluating BRAFTOVI ®( ...
6.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-learn-about-pf-08634404-alone-or-in-combination-with-enfortumab-vedotin-in-urothelial-canSymbiotic-GU-06: A Study to Learn About PF-08634404 Alone ...
It is for adults with a type of bladder cancer called locally advanced or metastatic urothelial cancer (LA/mUC), meaning the cancer has spread ...
PD-1 x VEGF Bispecific Antibody
PF-08634404 is an investigational compound. Its safety and efficacy have not been established. Go to section Close. Overview + Rationale Stage of Development.
Symbiotic-GU-06: A Study to Learn About PF-08634404 ...
The purpose of the study is to see if PF-08634404 is safe, how well it works, how it moves through the body, and how it affects the cancer. The study will also ...
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