PF-08634404 alone or with enfortumab vedotin for advanced urothelial (bladder) cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 trial tests the investigational drug PF-08634404 alone or in combination with enfortumab vedotin in adults with locally advanced or metastatic urothelial carcinoma. Participants who have already received prior therapy get PF-08634404 alone (Cohort A), while treatment-naive participants receive PF-08634404 plus enfortumab vedotin (Cohort B). The study examines safety, drug pharmacokinetics, tumor response by RECIST v1.1, and changes in cancer-related biomarkers. Eligible patients must have measurable disease, ECOG performance status 0–1, and adequate organ function, and will be treated at participating Highlands Oncology Group sites in Arkansas.

Why it matters

Who can join: the full rules

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.

Where it's running

• Highlands Oncology Group, PA
  Fayetteville, Arkansas, United States Recruiting
• Highlands Oncology Group, PA
  Rogers, Arkansas, United States Recruiting
• Highlands Oncology Group, PA
  Springdale, Arkansas, United States Recruiting
• UCLA Hematology/Oncology - Alhambra
  Alhambra, California, United States Recruiting
• UCLA Hematology/Oncology - Atascadero
  Atascadero, California, United States Recruiting
• UCLA Hematology/Oncology - Beverly Hills
  Beverly Hills, California, United States Recruiting

+134 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.