Actively Recruiting
Study to Evaluate Safety and Efficacy of PF-08634404 Alone and with Other Anticancer Agents in Adults With Advanced or Metastatic Renal Cell Carcinoma
Led by Pfizer · Updated on 2026-06-04
224
Participants Needed
109
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new medicine called PF-08634404 in adults with advanced Renal Cell Carcinoma (RCC), a type of kidney cancer that has spread locally or to other parts of the body. The study aims to assess the safety of PF-08634404 when given alone or in combination with other anticancer drugs and to observe how this cancer responds to these treatments. Participants must be adults with locally advanced or metastatic RCC who have not received prior treatment for their advanced kidney cancer. Participants will be randomly assigned to one of three groups: receiving PF-08634404 alone through intravenous (IV) infusion, PF-08634404 combined with ipilimumab, or PF-08634404 combined with axitinib. All treatments are administered by IV infusions at clinical study sites, where medical staff will monitor participants during and after each visit. The study includes phases 1b and 2 to evaluate safety and efficacy over time. During the study, participants will undergo regular assessments including measuring tumor response using RECIST criteria, monitoring for side effects and adverse events, and evaluating survival and progression-free survival for up to approximately three years. Laboratory tests, pharmacokinetics, and immunogenicity will also be tracked. The study will continue monitoring participants for safety up to 90 days after the last treatment dose, with the total participation duration lasting about three years.
CONDITIONS
Brief Title
Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at screening
- Diagnosed with locally advanced or metastatic renal cell carcinoma confirmed by histology or cytology
- At least one measurable and untreated lesion
- Adequate blood, liver, heart, and kidney function
- No prior systemic therapy for advanced renal cell carcinoma (immunotherapy after surgery allowed if over 12 months ago)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Eligible across all International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk categories
You will not qualify if you...
- Known active brain lesions or metastases including leptomeningeal, brainstem, meningeal, spinal cord metastases, or compression
- Significant risk of bleeding or fistula
- History of another cancer within the past 3 years
- History of allogeneic organ or stem cell transplant
- Active autoimmune diseases requiring systemic treatment within past 2 years
- Uncontrolled heart or other serious conditions within 6 months before first dose
- Major surgery or severe trauma within 4 weeks before first dose or planned during the study
- History of severe bleeding disorders or coagulation problems
- History of serious gastrointestinal issues like ulcers, perforation, fistula, obstruction, abscess, or bleeding within 6 months before first dose
- Acute or chronic symptomatic infections
- History of immune system deficiency
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.
Duration - Up to approximately 3 years
Participants receive PF-08634404 alone or in combination with other anticancer therapies as part of their treatment.
Trial Site Locations
Total: 109 locations
1
Mayo Clinic Building- Phoenix
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
2
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Not Yet Recruiting
3
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
4
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
Actively Recruiting
5
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
Actively Recruiting
6
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
Actively Recruiting
7
City of Hope Investigational Drug Services (IDS)
Duarte, California, United States, 91010
Actively Recruiting
8
UC San Diego Medical Center - Encinitas
Encinitas, California, United States, 92024
Not Yet Recruiting
9
City of Hope Investigational Drug Services (IDS)
Irvine, California, United States, 92618
Actively Recruiting
10
City of Hope
Irvine, California, United States, 92618
Actively Recruiting
11
UC San Diego / Moores Cancer Center
La Jolla, California, United States, 92037
Not Yet Recruiting
12
UC San Diego Koman Family Outpatient Pavilion
La Jolla, California, United States, 92037
Not Yet Recruiting
13
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, United States, 92037
Not Yet Recruiting
14
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, United States, 92037
Not Yet Recruiting
15
City of Hope
Long Beach, California, United States, 90813
Actively Recruiting
16
UC San Diego Medical Center - Bankers Hill
San Diego, California, United States, 92101
Not Yet Recruiting
17
UC San Diego McGrath Outpatient Pavilion - Hillcrest
San Diego, California, United States, 92103
Not Yet Recruiting
18
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103
Not Yet Recruiting
19
UC San Diego Medical Center - Rancho Bernardo
San Diego, California, United States, 92127
Not Yet Recruiting
20
City of Hope UPLAND
Upland, California, United States, 91786
Actively Recruiting
21
UC San Diego Medical Center - Vista
Vista, California, United States, 92081
Not Yet Recruiting
22
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States, 80218
Actively Recruiting
23
Mayo Clinic Pharmacy
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
24
Tennessee Oncology, PLLC- Ringgold
Ringgold, Georgia, United States, 30736
Not Yet Recruiting
25
City Of Hope - Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
26
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
27
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
28
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, United States, 02467
Not Yet Recruiting
29
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, United States, 55337
Actively Recruiting
30
Minnesota Oncology Hematology, P.A.
Chaska, Minnesota, United States, 55318
Actively Recruiting
31
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
32
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, United States, 55435
Actively Recruiting
33
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, United States, 55369
Actively Recruiting
34
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, United States, 55109
Actively Recruiting
35
Mayo Clinic Hospital, Methodist Campus, Research Pharmacy
Rochester, Minnesota, United States, 55902
Not Yet Recruiting
36
Mayo Clinic Cancer Center Outpatient Pharmacy
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
37
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, United States, 55125
Actively Recruiting
38
MSK Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
39
MSK Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
40
MSK Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
41
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
Actively Recruiting
42
New York Oncology Hematology - Clifton Park Cancer Center
Clifton Park, New York, United States, 12065
Actively Recruiting
43
MSK Commack
Commack, New York, United States, 11725
Actively Recruiting
44
MSK Westchester
Harrison, New York, United States, 10604
Actively Recruiting
45
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, United States, 11101
Actively Recruiting
46
Evelyn H. Lauder Breast and Imaging Center (BAIC)
New York, New York, United States, 10065
Actively Recruiting
47
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States, 10065
Actively Recruiting
48
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
49
MSK Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
50
Grand Strand Medical Center
Myrtle Beach, South Carolina, United States, 295724607
Actively Recruiting
51
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
52
Parkway Surgery Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
53
Tennessee Oncology, PLLC- Chattanooga Downtown
Chattanooga, Tennessee, United States, 37403
Not Yet Recruiting
54
Tennessee Oncology, PLLC - Chattanooga Med Park II
Chattanooga, Tennessee, United States, 37404
Not Yet Recruiting
55
Tennessee Oncology, PLLC - Chattanooga Memorial
Chattanooga, Tennessee, United States, 37404
Not Yet Recruiting
56
Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
Chattanooga, Tennessee, United States, 37404
Not Yet Recruiting
57
Tennessee Oncology, PLLC- Chattanooga East
Chattanooga, Tennessee, United States, 37421
Not Yet Recruiting
58
Tennessee Oncology, PLLC- Cookeville
Cookeville, Tennessee, United States, 38501
Not Yet Recruiting
59
Tennessee Oncology, PLLC-Dickson
Dickson, Tennessee, United States, 37055
Not Yet Recruiting
60
Tennessee Oncology, PLLC- Franklin Proton Center
Franklin, Tennessee, United States, 37067
Not Yet Recruiting
61
Tennessee Oncology, PLLC-Franklin
Franklin, Tennessee, United States, 37067
Not Yet Recruiting
62
Tennessee Oncology, PLLC-Gallatin
Gallatin, Tennessee, United States, 37066
Not Yet Recruiting
63
Tennessee Oncology, PLLC-Hendersonville
Hendersonville, Tennessee, United States, 37075
Not Yet Recruiting
64
Tennessee Oncology, PLLC-Lebanon
Lebanon, Tennessee, United States, 37090
Not Yet Recruiting
65
Tennessee Oncology, PLLC-Mount Juliet
Mount Juliet, Tennessee, United States, 37122
Not Yet Recruiting
66
Tennessee Oncology, PLLC-Murfreesboro
Murfreesboro, Tennessee, United States, 37129
Not Yet Recruiting
67
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
68
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
69
Tennessee Oncology, PLLC- Elliston Place Plaza
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
70
Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &Hematology
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
71
Tennessee Oncology, PLLC-Investigational Drug Services
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
72
Tennessee Oncology, PLLC- Saint Thomas West
Nashville, Tennessee, United States, 37205
Not Yet Recruiting
73
Tennessee Oncology, PLLC- Skyline
Nashville, Tennessee, United States, 37207
Not Yet Recruiting
74
Tennessee Oncology, PLLC- Southern Hills
Nashville, Tennessee, United States, 37211
Not Yet Recruiting
75
Tennessee Oncology, PLLC- Shelbyville
Shelbyville, Tennessee, United States, 37160
Not Yet Recruiting
76
Tennessee Oncology, PLLC- Smyrna
Smyrna, Tennessee, United States, 37167
Not Yet Recruiting
77
Texas Oncology - Central South
Austin, Texas, United States, 78705
Actively Recruiting
78
Texas Oncology - Central South
Austin, Texas, United States, 78731
Actively Recruiting
79
Texas Oncology - Central South
Austin, Texas, United States, 78745
Actively Recruiting
80
Texas Oncology - Central South
Austin, Texas, United States, 78758
Actively Recruiting
81
Texas Oncology - Gulf Coast
Beaumont, Texas, United States, 77702
Actively Recruiting
82
Texas Oncology - Central South
Harlingen, Texas, United States, 78550
Actively Recruiting
83
Texas Oncology - Gulf Coast
Houston, Texas, United States, 77024
Actively Recruiting
84
Texas Oncology - Gulf Coast
Houston, Texas, United States, 77054
Actively Recruiting
85
US Oncology Investigational Products Center (IPC)
Irving, Texas, United States, 75063
Actively Recruiting
86
US Oncology Investigational Products Center
Irving, Texas, United States, 75063
Actively Recruiting
87
Texas Oncology - Central South
McAllen, Texas, United States, 78503
Actively Recruiting
88
Texas Oncology - Gulf Coast
Pearland, Texas, United States, 77584
Actively Recruiting
89
Texas Oncology - Gulf Coast
Sugar Land, Texas, United States, 77479
Actively Recruiting
90
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States, 77380
Actively Recruiting
91
Texas Oncology - Central South
Waco, Texas, United States, 76712
Actively Recruiting
92
Texas Oncology - Gulf Coast
Webster, Texas, United States, 77598
Actively Recruiting
93
Texas Oncology - Central South
Weslaco, Texas, United States, 78596
Actively Recruiting
94
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, United States, 24060
Actively Recruiting
95
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
96
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, United States, 24457
Actively Recruiting
97
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Actively Recruiting
98
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, United States, 24153
Actively Recruiting
99
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, United States, 24382
Actively Recruiting
100
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States, 98684
Actively Recruiting
101
Minnesota Oncology Hematology, P.A.
Hudson, Wisconsin, United States, 54016
Actively Recruiting
102
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia, 4066
Actively Recruiting
103
Beijing Cancer hospital
Beijing, Beijing Municipality, China, 100142
Not Yet Recruiting
104
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024
Actively Recruiting
105
The University of Osaka Hospital
Suita, Osaka, Japan, 565-0871
Actively Recruiting
106
Keio university hospital
Shinjuku-ku, Tokyo, Japan, 1608582
Actively Recruiting
107
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Actively Recruiting
108
Yamagata University Hospital
Yamagata, Japan, 990-9585
Actively Recruiting
109
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Not Yet Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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