RecruitingPhase 1Phase 2NCT07227415

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


Sponsor

Pfizer

Enrollment

224 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called PF-08634404 — both alone and in combination with other cancer treatments — as a first-line treatment for people with advanced or metastatic kidney cancer (renal cell carcinoma) that cannot be surgically removed. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic kidney cancer - You have not received prior systemic treatment for kidney cancer - You have at least one measurable tumor - Your general health is good (ECOG 0 or 1) - Your heart, liver, and kidney function are adequate **You may NOT be eligible if...** - You have active cancer in the brain, spinal cord, or brain lining - You have had another cancer within the past 3 years - You have had an organ or stem cell transplant - You have an active autoimmune disease - You have had major surgery, significant heart problems, or severe bleeding disorders recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPF-08634404

Concentrate for solution for infusion

DRUGIpilimumab

Solution for infusion

DRUGAxitinib

Tablet


Locations(88)

Highlands Oncology Group

Fayetteville, Arkansas, United States

Highlands Oncology Group

Rogers, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States

City of Hope Investigational Drug Services (IDS)

Duarte, California, United States

City of Hope Investigational Drug Services (IDS)

Irvine, California, United States

City of Hope

Irvine, California, United States

Jacobs Medical Center (JMC)

La Jolla, California, United States

Koman Family Outpatient Pavilion (KOP)

La Jolla, California, United States

Moores Cancer Center

La Jolla, California, United States

San Diego Health Garden View Road- Encinitas

La Jolla, California, United States

UC San Diego Medical Center- Hillcrest

La Jolla, California, United States

City of Hope

Long Beach, California, United States

City of Hope UPLAND

Upland, California, United States

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, United States

Tennessee Oncology, PLLC- Ringgold

Ringgold, Georgia, United States

City Of Hope - Chicago

Zion, Illinois, United States

Minnesota Oncology Hematology, P.A.

Burnsville, Minnesota, United States

Minnesota Oncology Hematology, P.A.

Chaska, Minnesota, United States

Minnesota Oncology Hematology, P.A.

Coon Rapids, Minnesota, United States

Minnesota Oncology Hematology, P.A.

Edina, Minnesota, United States

Minnesota Oncology Hematology, P.A.

Maple Grove, Minnesota, United States

Minnesota Oncology Hematology, P.A.

Maplewood, Minnesota, United States

Minnesota Oncology Hematology, P.A.

Woodbury, Minnesota, United States

MSK Basking Ridge

Basking Ridge, New Jersey, United States

MSK Monmouth

Middletown, New Jersey, United States

MSK Bergen

Montvale, New Jersey, United States

New York Oncology Hematology, P.C.

Albany, New York, United States

New York Oncology Hematology - Clifton Park Cancer Center

Clifton Park, New York, United States

MSK Commack

Commack, New York, United States

MSK Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Long Island City, New York, United States

Evelyn H. Lauder Breast and Imaging Center (BAIC)

New York, New York, United States

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, United States

Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center

New York, New York, United States

MSK Nassau

Uniondale, New York, United States

Grand Strand Medical Center

Myrtle Beach, South Carolina, United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States

Parkway Surgery Center

Myrtle Beach, South Carolina, United States

Tennessee Oncology, PLLC- Chattanooga Downtown

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC - Chattanooga Med Park II

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC - Chattanooga Memorial

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC- Chattanooga East

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC- Cookeville

Cookeville, Tennessee, United States

Tennessee Oncology, PLLC-Dickson

Dickson, Tennessee, United States

Tennessee Oncology, PLLC- Franklin Proton Center

Franklin, Tennessee, United States

Tennessee Oncology, PLLC-Franklin

Franklin, Tennessee, United States

Tennessee Oncology, PLLC-Gallatin

Gallatin, Tennessee, United States

Tennessee Oncology, PLLC-Hendersonville

Hendersonville, Tennessee, United States

Tennessee Oncology, PLLC-Lebanon

Lebanon, Tennessee, United States

Tennessee Oncology, PLLC-Mount Juliet

Mount Juliet, Tennessee, United States

Tennessee Oncology, PLLC-Murfreesboro

Murfreesboro, Tennessee, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Tennessee Oncology, PLLC- Elliston Place Plaza

Nashville, Tennessee, United States

Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &Hematology

Nashville, Tennessee, United States

Tennessee Oncology, PLLC-Investigational Drug Services

Nashville, Tennessee, United States

Tennessee Oncology, PLLC- Saint Thomas West

Nashville, Tennessee, United States

Tennessee Oncology, PLLC- Skyline

Nashville, Tennessee, United States

Tennessee Oncology, PLLC- Southern Hills

Nashville, Tennessee, United States

Tennessee Oncology, PLLC- Shelbyville

Shelbyville, Tennessee, United States

Tennessee Oncology, PLLC- Smyrna

Smyrna, Tennessee, United States

Texas Oncology - Central South

Austin, Texas, United States

Texas Oncology - Central South

Austin, Texas, United States

Texas Oncology - Gulf Coast

Beaumont, Texas, United States

Texas Oncology - Gulf Coast

Houston, Texas, United States

Texas Oncology - Gulf Coast

Houston, Texas, United States

US Oncology Investigational Products Center (IPC)

Irving, Texas, United States

US Oncology Investigational Products Center

Irving, Texas, United States

Texas Oncology - Central South

McAllen, Texas, United States

Texas Oncology - Gulf Coast

Pearland, Texas, United States

Texas Oncology - Gulf Coast

Sugar Land, Texas, United States

Texas Oncology - Gulf Coast

The Woodlands, Texas, United States

Texas Oncology - Gulf Coast

Webster, Texas, United States

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Blacksburg, Virginia, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Low Moor, Virginia, United States

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Roanoke, Virginia, United States

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Salem, Virginia, United States

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Wytheville, Virginia, United States

Minnesota Oncology Hematology, P.A.

Hudson, Wisconsin, United States

Icon Cancer Centre Wesley

Auchenflower, Queensland, Australia

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

Keio university hospital

Shinjuku-ku, Tokyo, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Yamagata University Hospital

Yamagata, Japan

View Full Details on ClinicalTrials.gov

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NCT07227415


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