Actively Recruiting
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Led by Pfizer · Updated on 2026-04-21
294
Participants Needed
47
Research Sites
377 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to learn how a new medicine called PF-08052667 works when used by itself or together with another medicine called Bacillus Calmette Guerin (BCG), and/or a medicine called sasanlimab. This study is for adults who have a type of bladder cancer that hasn't spread into the muscle layer of the bladder but is more likely to come back or grow. It includes people whose cancer has come back or hasn't gone away after receiving standard treatments like BCG. It may also include people who, based on their doctor's opinion, cannot receive standard treatments or those treatments are not available to them. The study has three parts: * Part 1 (monotherapy dose escalation) will test PF-08052667 as a single-agent at increasing dose levels in participants with certain bladder cancer whose disease has worsened on or after standard treatments. * Part 2 (combination dose escalation) will test PF-08052667 in combination with BCG and/or sasanlimab (fixed dose) in participants with certain bladder cancer whose disease has worsened on or after standard treatments. * Part 3 (dose optimization and expansion) will further test PF-08052667 as a single agent or in combination with BCG and/or sasanlimab, at the dose(s) based on findings from Part 1 and Part 2 in participants with certain bladder cancer including those who has never received standard treatments. All participants will receive the study drug PF-08052667. Only participants in Part 2 and Part 3 of the study will also receive BCG and/or sasanlimab. PF-08052667 will be given as an intravesical infusion, which means it will be injected directly into the bladder. Sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin. For all parts, treatment with study medicines will continue until either a participant has decided to stop taking part in the study or is asked to leave the study for various reasons or up to about 2 years, whichever occurs first. Duration of trial participation for each participant will vary as long-term follow-up will continue after treatment discontinuation until loss to-follow-up or death, or until the study is stopped by the sponsor.
CONDITIONS
Official Title
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 as carcinoma in situ (CIS), with or without T1/Ta papillary disease
- For BCG unresponsive and BCG-exposed cohorts, persistent or recurrent disease after receiving at least 5 of 6 doses of BCG induction therapy
- Have refused or are ineligible or not appropriate for radical cystectomy
- Available tumor tissue sample within the last 6 months
- ECOG Performance Status of 0 or 1
You will not qualify if you...
- Receiving other anti-cancer therapy for non-muscle invasive bladder cancer or prior radiation therapy to the bladder
- Having renal or hepatic impairment or certain blood abnormalities as defined in the protocol
- Having an active, uncontrolled infection as specified in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 47 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Not Yet Recruiting
3
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Not Yet Recruiting
4
AdventHealth Orlando
Orlando, Florida, United States, 32803
Not Yet Recruiting
5
Moffitt Cancer Center at SouthShore
Ruskin, Florida, United States, 33570
Not Yet Recruiting
6
Moffitt Cancer Center - International Plaza
Tampa, Florida, United States, 33607
Not Yet Recruiting
7
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States, 33612
Not Yet Recruiting
8
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Not Yet Recruiting
9
Moffitt McKinley Hospital
Tampa, Florida, United States, 33612
Not Yet Recruiting
10
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States, 33544
Not Yet Recruiting
11
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
12
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
13
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
14
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Not Yet Recruiting
15
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Not Yet Recruiting
16
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
17
The University of Kansas - Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
18
The University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, United States, 66160
Actively Recruiting
19
The University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Actively Recruiting
20
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, United States, 66160
Actively Recruiting
21
The University of Kansas Hospital - Indian Creek Campus
Overland Park, Kansas, United States, 66211
Actively Recruiting
22
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States, 66205
Actively Recruiting
23
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
24
Upstate Specialty Services at Harrison Center
Syracuse, New York, United States, 13202
Not Yet Recruiting
25
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Not Yet Recruiting
26
SUNY Upstate Medical University-Community Campus
Syracuse, New York, United States, 13215
Not Yet Recruiting
27
Biorepository and Precision Pathology Center (BRPC)
Durham, North Carolina, United States, 27710
Actively Recruiting
28
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
29
Substrate Services Core Research Support (SSCRS)
Durham, North Carolina, United States, 27710
Actively Recruiting
30
Grand Strand Medical Center
Myrtle Beach, South Carolina, United States, 295724607
Actively Recruiting
31
AUC Urologists, LLC
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
32
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
33
Parkway Surgery Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
34
Coastal Eye Group
Myrtle Beach, South Carolina, United States, 29579
Actively Recruiting
35
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
Actively Recruiting
36
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Not Yet Recruiting
37
Baptist M&S Imaging (Medical Center)
San Antonio, Texas, United States, 78229
Actively Recruiting
38
USA Clinical Trials
San Antonio, Texas, United States, 78229
Actively Recruiting
39
MCOA Eye Associates
San Antonio, Texas, United States, 78240
Actively Recruiting
40
Gustave Roussy
Villejuif, VAL DE Marne, France, 94800
Not Yet Recruiting
41
Rabin Medical Center
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
42
Sheba Medical Center
Ramat Gan, Central District, Israel, 5265601
Actively Recruiting
43
Hadassah Medical Center
Jerusalem, Jerusalem, Israel, 9112001
Actively Recruiting
44
Samsung Medical Center
Seoul, Seoul Teukbyeolsi [seoul], South Korea, 06351
Not Yet Recruiting
45
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
Not Yet Recruiting
46
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi, South Korea, 03722
Not Yet Recruiting
47
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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