Purpose of this Study
To join this study, patients must have a new diagnosis of cervical cancer confirmed by a lab test. The cancer can be one of these types: squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma. The cancer must be locally advanced, which means it has grown but has not spread far. It can be stage III or stage IVA.
Patients cannot have had their whole uterus removed for cervical cancer, but if part of the uterus was removed for another reason, they can still join. They cannot plan to have their uterus removed as part of their treatment. The cancer cannot have spread to certain lymph nodes high in the body.
Patients must not have had surgery, radiation, or medicine for cervical cancer before. They also cannot have had immunotherapy or radiation to the pelvis for any reason. Patients must be 18 or older.
Who Can Participate?
Eligibility
Adults can join this study if they have urothelial cancer that has spread or is hard to treat with surgery. Before joining, they will have a screening visit where doctors check their health and test if they qualify. People in the study must also agree to give blood, urine, and tissue samples when needed.
Age Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is being done to see if PF-08634404 is safe and how it works when given alone or with another medicine called enfortumab vedotin. PF-08634404 is made to help the immune system fight tumors and to reduce the blood that feeds tumor cells. Enfortumab vedotin works by finding and killing cancer cells.
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
An Interventional, Phase 1b/2, Open-Label Study to Investigate the Tolerability, Antitumor Activity, and Pharmacokinetics of PF-08634404 Monotherapy or in Combination With Enfortumab Vedotin in Adult Participants With Locally Advanced or Metastatic Urothelial Cancer, C6461006
Principal Investigator
Christopher
Hoimes
Protocol Number
PRO00119281
NCT ID
NCT07421700
Phase
I/II
Enrollment Status
Pending Open to Enrollment