Actively Recruiting
Study to Investigate Safety and Effects of PF-08634404 Alone or With Enfortumab Vedotin in Adults With Advanced or Metastatic Urothelial Cancer
Led by Pfizer · Updated on 2026-06-04
132
Participants Needed
50
Research Sites
39 weeks
Total Duration
On this page
Sponsors
P
Pfizer
Lead Sponsor
A
Astellas Pharma Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new medicine called PF-08634404 for adults with locally advanced or metastatic urothelial cancer, a type of bladder cancer that has spread to nearby tissues or other parts of the body. The study aims to assess the safety, effectiveness, how the medicine moves through the body, and its impact on cancer-related markers. This is an open-label, interventional trial sponsored by Pfizer. The study includes two groups: Cohort A consists of participants who have already received treatment for their cancer and will receive PF-08634404 alone through intravenous infusion. Cohort B includes participants who have not had prior treatment and will receive PF-08634404 combined with another cancer medicine called enfortumab vedotin, also through IV infusion. Treatment will continue as long as it is helpful and side effects are manageable. Before starting, participants undergo screening to confirm eligibility. During the study, regular visits will include treatment administration, health checks, and tests such as scans to monitor cancer response. Researchers will measure outcomes like confirmed objective response rate, side effects, duration of response, progression-free survival, and overall survival over up to three years. Participants may continue treatment even if cancer worsens, with agreement from their doctor and the study sponsor. Safety monitoring will continue for 90 days after treatment ends.
CONDITIONS
Brief Title
Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at screening
- Histologically confirmed locally advanced or metastatic urothelial carcinoma
- Measurable disease based on RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Adequate organ function including blood, liver, and kidney
- Willingness to follow study procedures and provide informed consent
- Agreement to use effective contraception if capable of childbearing
You will not qualify if you...
- History of another cancer within 3 years before first study dose or residual disease from previous malignancy
- Known active central nervous system lesions or metastases
- Active autoimmune disease needing systemic treatment within past 2 years
- Participation in another investigational study within 30 days or 5 half-lives of investigational product
- Pregnant or breastfeeding individuals
- Inability or unwillingness to follow study requirements
- Study staff or immediate family involved in study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years
Participants receive PF-08634404 alone or in combination with enfortumab vedotin as treatment for advanced or metastatic urothelial cancer.
Treatment visits as scheduled by the study team
Duration - Up to approximately 3 years
Participants are monitored for safety and treatment effects after the last dose of study intervention.
Follow-up visits through 90 days after last treatment and additional long-term assessments
Trial Site Locations
Total: 50 locations
1
Highlands Oncology Group, PA
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
2
Highlands Oncology Group, PA
Rogers, Arkansas, United States, 72758
Actively Recruiting
3
Highlands Oncology Group, PA
Springdale, Arkansas, United States, 72762
Actively Recruiting
4
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
Actively Recruiting
5
City of Hope Investigational Drug Services (IDS)
Duarte, California, United States, 91010
Actively Recruiting
6
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
7
City of Hope Investigational Drug Service (IDS)
Irvine, California, United States, 92618
Actively Recruiting
8
City of Hope-Long Beach (ELM)
Long Beach, California, United States, 90813
Actively Recruiting
9
City of Hope UPLAND
Upland, California, United States, 91786
Actively Recruiting
10
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States, 80012
Actively Recruiting
11
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States, 80218
Actively Recruiting
12
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States, 80124
Actively Recruiting
13
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
Actively Recruiting
14
New York Oncology Hematology
Albany, New York, United States, 12206
Actively Recruiting
15
New York Oncology Hematology
Clifton Park, New York, United States, 12065
Actively Recruiting
16
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
17
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
18
Texas Oncology - Central/South Texas
Austin, Texas, United States, 78705
Actively Recruiting
19
Texas Oncology - Central/South Texas
Austin, Texas, United States, 78731
Actively Recruiting
20
Texas Oncology - Central/South Texas
Austin, Texas, United States, 78745
Actively Recruiting
21
Texas Oncology - Central South
Austin, Texas, United States, 78758
Actively Recruiting
22
Texas Oncology - Gulf Coast
Beaumont, Texas, United States, 77702
Actively Recruiting
23
Texas Oncology - Central/South Texas
Harlingen, Texas, United States, 78550
Actively Recruiting
24
Texas Oncology - Gulf Coast
Houston, Texas, United States, 77024
Actively Recruiting
25
Texas Oncology - Gulf Coast
Houston, Texas, United States, 77054
Actively Recruiting
26
US Oncology Investigational Products Center (IPC)
Irving, Texas, United States, 75063
Actively Recruiting
27
Texas Oncology - Central/South Texas
McAllen, Texas, United States, 78503
Actively Recruiting
28
Texas Oncology - Gulf Coast
Pearland, Texas, United States, 77584
Actively Recruiting
29
Texas Oncology - Gulf Coast
Sugar Land, Texas, United States, 77479
Actively Recruiting
30
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States, 77380
Actively Recruiting
31
Texas Oncology - Central/South Texas
Waco, Texas, United States, 76712
Actively Recruiting
32
Texas Oncology - Gulf Coast
Webster, Texas, United States, 77598
Actively Recruiting
33
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Blacksburg, Virginia, United States, 24060
Actively Recruiting
34
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
35
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Low Moor, Virginia, United States, 24457
Actively Recruiting
36
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
37
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Actively Recruiting
38
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Salem, Virginia, United States, 24153
Actively Recruiting
39
Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
Wytheville, Virginia, United States, 24382
Actively Recruiting
40
Macquarie University
North Ryde, New South Wales, Australia, 2109
Actively Recruiting
41
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia, 4066
Actively Recruiting
42
Monash Health
Clayton, Victoria, Australia, 3168
Not Yet Recruiting
43
Beijing Cancer hospital
Beijing, Beijing Municipality, China, 100142
Not Yet Recruiting
44
Keio university hospital
Shinjuku-ku, Tokyo, Japan, 1608582
Actively Recruiting
45
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Actively Recruiting
46
Yamagata University Hospital
Yamagata, Japan, 990-9585
Actively Recruiting
47
Pan American Center for Oncology Trials, LLC - Manati Office
Manati, Puerto Rico, 00674
Actively Recruiting
48
Pan American Center for Oncology Trials, LLC - Mayaguez Office
Mayagüez, Puerto Rico, 00680
Actively Recruiting
49
Hospital Oncologico Dr. Isaac Gonzalez-Martinez
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
50
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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