Clinical trial for Non-muscle Invasive Bladder Cancer
Official title A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
ClinicalTrials.gov ID: NCT07206225
What this study is testing
What is PF-08052667?
PF-08052667 is an investigational intravesical medicine being studied for non‑muscle invasive bladder cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how PF‑08052667 works alone or together with BCG and/or sasanlimab, and to find the best dose.
- Who it's for
- Adults whose bladder cancer has returned or not responded to standard treatments like BCG, or who cannot receive those treatments.
- What's involved
- Participants receive PF‑08052667 directly into the bladder; some also receive BCG and/or sasanlimab injections under the skin.
- Time commitment
- Treatment continues until the participant stops or is withdrawn, up to about 2 years, with follow‑up after stopping until loss to follow‑up, death, or study end.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or older (or the minimum age of consent per local regulations)
- Histological diagnosis of high-risk, non-muscle invasive urothelial carcinoma of the bladder defined according to the WHO grading system as carcinoma...
- BCG unresponsive and BCG-exposed cohorts should have persistent or recurrent disease after receiving at least 5 out of 6 doses of the BCG induction...
- Have refused or are ineligible or not appropriate for radical cystectomy
- Tissue Requirement: Available tumor tissue within the last 6 months.
You likely can't join if
- Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed
- Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol
- Participants with active, uncontrolled infection as specified in the protocol
See the full eligibility criteria
- 18 years of age or older (or the minimum age of consent per local regulations)
- Histological diagnosis of high-risk, non-muscle invasive urothelial carcinoma of the bladder defined according to the WHO grading system as carcinoma in situ (CIS), with or without concurrent T1/Ta papillary disease.
- BCG unresponsive and BCG-exposed cohorts should have persistent or recurrent disease after receiving at least 5 out of 6 doses of the BCG induction therapy.
- Have refused or are ineligible or not appropriate for radical cystectomy
- Tissue Requirement: Available tumor tissue within the last 6 months. On-treatment tumor biopsy is optional, unless mandated based on emerging data, or participating in the Biomarker Cohort, or for disease assessment
- ECOG PS 0 or 1
- Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed
- Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol
- Participants with active, uncontrolled infection as specified in the protocol
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Ruskin, Florida, United States
- Tampa, Florida, United States
- Wesley Chapel, Florida, United States
- Atlanta, Georgia, United States
- Iowa City, Iowa, United States
- Fairway, Kansas, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
- Westwood, Kansas, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Syracuse, New York, United States
- Uniondale, New York, United States
- Durham, North Carolina, United States
- Myrtle Beach, South Carolina, United States
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Ruskin, Florida, United States; Tampa, Florida, United States; Wesley Chapel, Florida, United States; Atlanta, Georgia, United States; Iowa City, Iowa, United States and 29 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.