PF-08634404 + Enfortumab Vedotin for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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 metastatic urothelial cancer (LA/mUC), meaning the cancer has spread to nearby tissues or other parts of the body.
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 look at how the medicine may change certain markers in the body that are linked to cancer.
To join the study, participants must:
* Be adults (18 years or older) and
* Have locally advanced or metastatic urothelial cancer,
The study has two groups:
* Cohort A: People who have already received treatment for their cancer will get the study medicine ( PF-08634404) alone.
* Cohort B: People who have not had treatment before will get the study medicine along with another cancer medicine called enfortumab vedotin.
Everyone in the study will get the study medicine through a vein (IV infusion) with or without enfortumab vedotin. Treatment will continue as long as it helps and side effects are manageable.
Before starting, participants will go through a screening period to check if they are eligible. During the study, they will have regular visits for treatment, health checks, and tests to see how the cancer is responding. Scans will be done regularly to monitor the cancer.
If the cancer gets worse but the treatment is still helping and side effects are manageable, participants may be allowed to continue treatment with their doctor's and the sponsor's agreement.
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
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
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
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