Study on PF-08634404 Alone or with Enfortumab Vedotin for Urothelial Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT07421700
This clinical trial is exploring a new medicine, PF-08634404, for adults with advanced bladder cancer that has spread. The study aims to determine the safety and effectiveness of PF-08634404, alone or combined with another drug, Enfortumab Vedotin.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to learn more about a new medicine called PF-08634404 for treating a type of bladder cancer known as locally advanced or metastatic urothelial cancer. This means the cancer has spread to nearby tissues or other parts of the body. The study will assess if PF-08634404 is safe, how well it works, how it moves through the body, and its effects on cancer-related markers. Participants will be divided into two groups: one group will receive PF-08634404 alone, and the other will receive it with another cancer drug, Enfortumab Vedotin. All participants will receive the treatment through an IV infusion. The study will continue as long as the treatment is effective and side effects are manageable. Participants will undergo regular health checks and scans to monitor the cancer's response.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older.
- Have a confirmed diagnosis of locally advanced or metastatic urothelial cancer.
- Have measurable cancer according to specific medical criteria.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ function, including blood, liver, and kidney health.
- Agree to follow study procedures and provide informed consent.
- If of childbearing potential, agree to use effective contraception during the study and for a specified time after the last dose.
Exclusion Criteria
- Have had another cancer within the last 3 years or have remaining disease from a previous cancer.
- Have active cancer in the central nervous system, such as in the brain or spinal cord.
- Have an active autoimmune disease requiring treatment in the past 2 years.
- Have participated in another investigational study recently.
- Are pregnant or breastfeeding.
- Are unable or unwilling to follow study requirements.
- Are study staff or immediate family members involved in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group, PA | 72703 | Fayetteville | Arkansas |
| Highlands Oncology Group, PA | 72758 | Rogers | Arkansas |
| Highlands Oncology Group, PA | 72762 | Springdale | Arkansas |
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | 91010 | Duarte | California |
| City of Hope Investigational Drug Services (IDS) | 91010 | Duarte | California |
| City of Hope at Irvine Lennar | 92618 | Irvine | California |
| City of Hope Investigational Drug Service (IDS) | 92618 | Irvine | California |
| City of Hope-Long Beach (ELM) | 90813 | Long Beach | California |
| City of Hope UPLAND | 91786 | Upland | California |
| Rocky Mountain Cancer Centers, LLP | 80012 | Aurora | Colorado |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.