No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
132 (estimated)
Sponsor
Pfizer · Industry
Who this trial is looking for
This trial is looking for adults with locally advanced or metastatic bladder cancer. Participants will receive a new medicine either alone or with another treatment, and they will have regular check-ups to monitor their health and cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have locally advanced or metastatic urothelial cancer.
My cancer can be measured.
My overall health is good with an ECOG score of 0 or 1.
My organ functions are adequate.
I can follow study procedures and give my consent.
If applicable, I will use effective birth control during the study.
You may not be able to join if
I have had another cancer in the past 3 years.
I have known active lesions in my brain or spinal cord.
I have had an active autoimmune disease needing treatment in the past 2 years.
I have participated in another clinical study in the past month.
I am pregnant or breastfeeding.
I cannot follow study requirements.
I am a study staff member or related to one.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 th…
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years at the time of screening.
* Histologically confirmed locally advanced or metastatic urothelial carcinoma (LA/mUC).
* Measurable disease per RECIST v1.1 criteria.
* ECOG performance status of 0 or 1.
* Adequate organ function, including hematologic, hepatic, and r…
Inclusion Criteria:
* Age ≥18 years at the time of screening.
* Histologically confirmed locally advanced or metastatic urothelial carcinoma (LA/mUC).
* Measurable disease per RECIST v1.1 criteria.
* ECOG performance status of 0 or 1.
* Adequate organ function, including hematologic, hepatic, and renal parameters.
* Willingness to comply with study procedures and provide informed consent.
* For participants of childbearing potential: agreement to use effective contraception during the study and for a defined period after the last dose.
Exclusion Criteria:
Participants will be excluded if they meet any of the following:
* History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
* Known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
* Active autoimmune diseases requiring systemic treatment within the past 2 years
* Participation in another investigational study within 30 days or 5 half-lives of the investigational product.
* Pregnant or breastfeeding individuals.
* Inability or unwillingness to comply with study requirements.
* Study staff or their immediate family members directly involved in the conduct of the study.
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