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NCT07227415PHASE1, PHASE2Recruiting

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

Pfizer

Start Date

2/10/2026

Completion Date

11/1/2028

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 18 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 Exclusion Criteria: 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

Interventions

DRUG

PF-08634404

DRUG

Ipilimumab

DRUG

Axitinib

Interested in This Trial?

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Conditions

Carcinoma, Renal CellAdvanced Renal Cell CarcinomaRenal CancerRenal NeoplasmClear Cell Renal Cell CarcinomaMetastatic Renal Cell CarcinomaClear-cell Metastatic Renal Cell CarcinomaCarcinoma, Renal Cell MetastasisAdvanced or Metastatic Renal Cell CarcinomaCarcinoma, Renal Cell, AdvancedMetastatic Renal Cell CancerMetastatic Renal Cell Carcinoma ( mRCC)Metastatic/Advanced Renal Cell Carcinoma

Locations

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