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
AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA
3 other identifiers
interventional
224
6 countries
128
Brief Summary
This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them. To join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer. Participants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2026
Typical duration for phase_1
128 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2025
CompletedFirst Posted
Study publicly available on registry
November 12, 2025
CompletedStudy Start
First participant enrolled
February 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
July 6, 2026
June 1, 2026
1.7 years
November 7, 2025
July 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator
ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1 as assessed by investigator.
Up to approximately 3 years
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Through 90 days after the last study intervention (Up to approximately 3 years)
Number of participants with dose limiting toxicity (DLT)
The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2).
Though end of DLT evaluation period (Up to approximately 3 years)
Secondary Outcomes (6)
Duration of Response (DOR) per RECIST v1.1 by investigator
Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Up to approximately 3 years
Overall Survival (OS)
Up to approximately 3 years
Number of Participants With Clinical Laboratory Abnormalities
Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (approximately 3 years)
Pharmacokinetics (PK): Serum concentration of PF-08634404
Up to 37 days after the last dose of treatment
- +1 more secondary outcomes
Study Arms (3)
Cohort A
EXPERIMENTALParticipants will receive PF-08634404 IV.
Cohort B
EXPERIMENTALParticipants will receive PF-08634404 in combination with ipilimumab.
Cohort C
EXPERIMENTALParticipants will receive PF-08634404 IV in combination with axitinib.
Interventions
Eligibility Criteria
You may qualify if:
- years of age or older at screening
- Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology/cytology
- At least one measurable (as defined by the investigator) and untreated lesion
- Adequate hematologic, hepatic, cardiac and renal function
- No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received \>12 months prior)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories
You may not qualify if:
- Participants may be excluded if they meet any of the following:
- Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.
- Clinically significant risk of haemorrhage or fistula
- History of another malignancy within 3 years
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- active autoimmune diseases requiring systemic treatment within the past 2 years
- uncontrolled cardiac and other comorbidities within 6 months prior to the first dose
- Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study
- History of severe bleeding tendency or coagulation dysfunction
- History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose
- Acute, chronic or symptomatic infections
- Participants with history of immunodeficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (128)
Mayo Clinic Building- Phoenix
Phoenix, Arizona, 85054, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group
Rogers, Arkansas, 72758, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010, United States
City of Hope Investigational Drug Services (IDS)
Duarte, California, 91010, United States
UC San Diego Medical Center - Encinitas
Encinitas, California, 92024, United States
City of Hope Investigational Drug Services (IDS)
Irvine, California, 92618, United States
City of Hope
Irvine, California, 92618, United States
UC San Diego / Moores Cancer Center
La Jolla, California, 92037, United States
UC San Diego Koman Family Outpatient Pavilion
La Jolla, California, 92037, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, 92037, United States
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, 92037, United States
City of Hope
Long Beach, California, 90813, United States
UC San Diego Medical Center - Bankers Hill
San Diego, California, 92101, United States
UC San Diego McGrath Outpatient Pavilion - Hillcrest
San Diego, California, 92103, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
UC San Diego Medical Center - Rancho Bernardo
San Diego, California, 92127, United States
City of Hope UPLAND
Upland, California, 91786, United States
UC San Diego Medical Center - Vista
Vista, California, 92081, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218, United States
Mayo Clinic Pharmacy
Jacksonville, Florida, 32224, United States
Orlando Health Ambulatory Care Center
Orlando, Florida, 32806, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Orlando Health Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Tennessee Oncology, PLLC- Ringgold
Ringgold, Georgia, 30736, United States
City Of Hope - Chicago
Zion, Illinois, 60099, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber/Mass General Brigham Cancer Care, Inc
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, 02467, United States
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, 55337, United States
Minnesota Oncology Hematology, P.A.
Chaska, Minnesota, 55318, United States
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, 55435, United States
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, 55109, United States
Mayo Clinic Hospital, Methodist Campus, Research Pharmacy
Rochester, Minnesota, 55902, United States
Mayo Clinic Cancer Center Outpatient Pharmacy
Rochester, Minnesota, 55905, United States
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, 55125, United States
MSK Basking Ridge
Basking Ridge, New Jersey, 07920, United States
MSK Monmouth
Middletown, New Jersey, 07748, United States
MSK Bergen
Montvale, New Jersey, 07645, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
New York Oncology Hematology - Clifton Park Cancer Center
Clifton Park, New York, 12065, United States
MSK Commack
Commack, New York, 11725, United States
MSK Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York, 11101, United States
Evelyn H. Lauder Breast and Imaging Center (BAIC)
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065, United States
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
MSK Nassau
Uniondale, New York, 11553, United States
Grand Strand Medical Center
Myrtle Beach, South Carolina, 295724607, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572, United States
Parkway Surgery Center
Myrtle Beach, South Carolina, 29572, United States
Tennessee Oncology, PLLC- Chattanooga Downtown
Chattanooga, Tennessee, 37403, United States
Tennessee Oncology, PLLC - Chattanooga Med Park II
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Chattanooga Memorial
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC- Chattanooga East
Chattanooga, Tennessee, 37421, United States
Tennessee Oncology, PLLC- Cookeville
Cookeville, Tennessee, 38501, United States
Tennessee Oncology, PLLC-Dickson
Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC- Franklin Proton Center
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC-Franklin
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC-Gallatin
Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC-Hendersonville
Hendersonville, Tennessee, 37075, United States
Tennessee Oncology, PLLC-Lebanon
Lebanon, Tennessee, 37090, United States
Tennessee Oncology, PLLC-Mount Juliet
Mount Juliet, Tennessee, 37122, United States
Tennessee Oncology, PLLC-Murfreesboro
Murfreesboro, Tennessee, 37129, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC- Elliston Place Plaza
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &Hematology
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC-Investigational Drug Services
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC- Saint Thomas West
Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC- Skyline
Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC- Southern Hills
Nashville, Tennessee, 37211, United States
Tennessee Oncology, PLLC- Shelbyville
Shelbyville, Tennessee, 37160, United States
Tennessee Oncology, PLLC- Smyrna
Smyrna, Tennessee, 37167, United States
Texas Oncology - Central South
Austin, Texas, 78705, United States
Texas Oncology - Central South
Austin, Texas, 78731, United States
Texas Oncology - Central South
Austin, Texas, 78745, United States
Texas Oncology - Central South
Austin, Texas, 78758, United States
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702, United States
The University of Texas, MD Anderson Cancer Center - Conroe
Conroe, Texas, 77384, United States
Texas Oncology - Central South
Harlingen, Texas, 78550, United States
Texas Oncology - Gulf Coast
Houston, Texas, 77024, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology - Gulf Coast
Houston, Texas, 77054, United States
The University of Texas, MD Anderson Cancer Center - West Houston
Houston, Texas, 77079, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
US Oncology Investigational Products Center
Irving, Texas, 75063, United States
The University of Texas, MD Anderson Cancer Center - League City
League City, Texas, 77573, United States
Texas Oncology - Central South
McAllen, Texas, 78503, United States
Texas Oncology - Gulf Coast
Pearland, Texas, 77584, United States
The University of Texas, MD Anderson Cancer Center - Sugar Land
Sugar Land, Texas, 77478, United States
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380, United States
Texas Oncology - Central South
Waco, Texas, 76712, United States
Texas Oncology - Gulf Coast
Webster, Texas, 77598, United States
Texas Oncology - Central South
Weslaco, Texas, 78596, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, 24457, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, 24153, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, 24382, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684, United States
Minnesota Oncology Hematology, P.A.
Hudson, Wisconsin, 54016, United States
Icon Cancer Centre Wesley
Auchenflower, Queensland, 4066, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, 315010, China
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Saxony, 01307, Germany
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
The University of Osaka Hospital
Suita, Osaka, 565-0871, Japan
Keio university hospital
Shinjuku-ku, Tokyo, 1608582, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], 08041, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2025
First Posted
November 12, 2025
Study Start
February 10, 2026
Primary Completion (Estimated)
November 2, 2027
Study Completion (Estimated)
November 1, 2028
Last Updated
July 6, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.