Recruiting

Phase 1

Phase 2

PF-08634404Symbiotic-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

Sponsor:

Pfizer

Code:

NCT07227415

Conditions

Carcinoma, Renal Cell

Advanced Renal Cell Carcinoma

Renal Cancer

Renal Neoplasm

Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08634404

Ipilimumab

Axitinib

Study Details

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.

Conditions

Carcinoma, Renal Cell

Advanced Renal Cell Carcinoma

Renal Cancer

Renal Neoplasm

Clear Cell Renal Cell Carcinoma

Study ID

NCT07227415

Start date

Feb 10, 2026

Status verified date

Jun, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 2, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A

Participants will receive PF-08634404 IV.

experimental: Cohort B

Participants will receive PF-08634404 in combination with ipilimumab.

experimental: Cohort C

Participants will receive PF-08634404 IV in combination with axitinib.

Interventions

PF-08634404

Concentrate for solution for infusion

Ipilimumab

Solution for infusion

Axitinib

Tablet

Primary outcome measure

Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator [ Time Frame: Up to approximately 3 years ]
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Through 90 days after the last study intervention (Up to approximately 3 years) ]
Number of participants with dose limiting toxicity (DLT) [ Time Frame: Though end of DLT evaluation period (Up to approximately 3 years) ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Mayo Clinic Building- Phoenix

Recruiting

Phoenix, Arizona, United States, 85054

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Highlands Oncology Group

Recruiting

Fayetteville, Arkansas, United States, 72703

Highlands Oncology Group

Recruiting

Rogers, Arkansas, United States, 72758

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

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

Recruiting

Duarte, California, United States, 91010

City of Hope Investigational Drug Services (IDS)

Recruiting

Duarte, California, United States, 91010

City of Hope Investigational Drug Services (IDS)

Recruiting

Irvine, California, United States, 92618

City of Hope

Recruiting

Irvine, California, United States, 92618

City of Hope

Recruiting

Long Beach, California, United States, 90813

City of Hope UPLAND

Recruiting

Upland, California, United States, 91786

Rocky Mountain Cancer Centers, LLP

Recruiting

Denver, Colorado, United States, 80218

Tennessee Oncology, PLLC- Ringgold

Recruiting

Ringgold, Georgia, United States, 30736

City Of Hope - Chicago

Recruiting

Zion, Illinois, United States, 60099

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Dana Farber/Mass General Brigham Cancer Care, Inc

Recruiting

Boston, Massachusetts, United States, 02215

Dana-Farber Cancer Institute - Chestnut Hill

Recruiting

Newton, Massachusetts, United States, 02467

Minnesota Oncology Hematology, P.A.

Recruiting

Burnsville, Minnesota, United States, 55337

Minnesota Oncology Hematology, P.A.

Recruiting

Chaska, Minnesota, United States, 55318

Minnesota Oncology Hematology, P.A.

Recruiting

Coon Rapids, Minnesota, United States, 55433

Minnesota Oncology Hematology, P.A.

Recruiting

Edina, Minnesota, United States, 55435

Minnesota Oncology Hematology, P.A.

Recruiting

Maple Grove, Minnesota, United States, 55369

Minnesota Oncology Hematology, P.A.

Recruiting

Maplewood, Minnesota, United States, 55109

Mayo Clinic Hospital, Methodist Campus, Research Pharmacy

Recruiting

Rochester, Minnesota, United States, 55902

Mayo Clinic Cancer Center Outpatient Pharmacy

Recruiting

Rochester, Minnesota, United States, 55905

Minnesota Oncology Hematology, P.A.

Recruiting

Woodbury, Minnesota, United States, 55125

MSK Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

MSK Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

MSK Bergen

Recruiting

Montvale, New Jersey, United States, 07645

New York Oncology Hematology, P.C.

Recruiting

Albany, New York, United States, 12206

New York Oncology Hematology - Clifton Park Cancer Center

Recruiting

Clifton Park, New York, United States, 12065

MSK Commack

Recruiting

Commack, New York, United States, 11725

MSK Westchester

Recruiting

Harrison, New York, United States, 10604

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Recruiting

Long Island City, New York, United States, 11101

Evelyn H. Lauder Breast and Imaging Center (BAIC)

Recruiting

New York, New York, United States, 10065

Memorial Sloan Kettering Cancer Center - Main Campus

Recruiting

New York, New York, United States, 10065

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

Recruiting

New York, New York, United States, 10065

MSK Nassau

Recruiting

Uniondale, New York, United States, 11553

Grand Strand Medical Center

Recruiting

Myrtle Beach, South Carolina, United States, 295724607

Carolina Urologic Research Center, LLC

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Parkway Surgery Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Tennessee Oncology, PLLC- Chattanooga Downtown

Recruiting

Chattanooga, Tennessee, United States, 37403

Tennessee Oncology, PLLC - Chattanooga Med Park II

Recruiting

Chattanooga, Tennessee, United States, 37404

Tennessee Oncology, PLLC - Chattanooga Memorial

Recruiting

Chattanooga, Tennessee, United States, 37404

Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage

Recruiting

Chattanooga, Tennessee, United States, 37404

Tennessee Oncology, PLLC- Chattanooga East

Recruiting

Chattanooga, Tennessee, United States, 37421

Tennessee Oncology, PLLC- Cookeville

Recruiting

Cookeville, Tennessee, United States, 38501

Tennessee Oncology, PLLC-Dickson

Recruiting

Dickson, Tennessee, United States, 37055

Tennessee Oncology, PLLC- Franklin Proton Center

Recruiting

Franklin, Tennessee, United States, 37067

Tennessee Oncology, PLLC-Franklin

Recruiting

Franklin, Tennessee, United States, 37067

Tennessee Oncology, PLLC-Gallatin

Recruiting

Gallatin, Tennessee, United States, 37066

Tennessee Oncology, PLLC-Hendersonville

Recruiting

Hendersonville, Tennessee, United States, 37075

Tennessee Oncology, PLLC-Lebanon

Recruiting

Lebanon, Tennessee, United States, 37090

Tennessee Oncology, PLLC-Mount Juliet

Recruiting

Mount Juliet, Tennessee, United States, 37122

Tennessee Oncology, PLLC-Murfreesboro

Recruiting

Murfreesboro, Tennessee, United States, 37129

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC- Elliston Place Plaza

Recruiting

Nashville, Tennessee, United States, 37203

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

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC-Investigational Drug Services

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC- Saint Thomas West

Recruiting

Nashville, Tennessee, United States, 37205

Tennessee Oncology, PLLC- Skyline

Recruiting

Nashville, Tennessee, United States, 37207

Tennessee Oncology, PLLC- Southern Hills

Recruiting

Nashville, Tennessee, United States, 37211

Tennessee Oncology, PLLC- Shelbyville

Recruiting

Shelbyville, Tennessee, United States, 37160

Tennessee Oncology, PLLC- Smyrna

Recruiting

Smyrna, Tennessee, United States, 37167

Texas Oncology - Central South

Recruiting

Austin, Texas, United States, 78705

Texas Oncology - Central South

Recruiting

Austin, Texas, United States, 78731

Texas Oncology - Central South

Recruiting

Austin, Texas, United States, 78745

Texas Oncology - Central South

Recruiting

Austin, Texas, United States, 78758

Texas Oncology - Gulf Coast

Recruiting

Beaumont, Texas, United States, 77702

Texas Oncology - Central South

Recruiting

Harlingen, Texas, United States, 78550

Texas Oncology - Gulf Coast

Recruiting

Houston, Texas, United States, 77024

Texas Oncology - Gulf Coast

Recruiting

Houston, Texas, United States, 77054

US Oncology Investigational Products Center (IPC)

Recruiting

Irving, Texas, United States, 75063

US Oncology Investigational Products Center

Recruiting

Irving, Texas, United States, 75063

Texas Oncology - Central South

Recruiting

McAllen, Texas, United States, 78503

Texas Oncology - Gulf Coast

Recruiting

Pearland, Texas, United States, 77584

Texas Oncology - Gulf Coast

Recruiting

Sugar Land, Texas, United States, 77479

Texas Oncology - Gulf Coast

Recruiting

The Woodlands, Texas, United States, 77380

Texas Oncology - Central South

Recruiting

Waco, Texas, United States, 76712

Texas Oncology - Gulf Coast

Recruiting

Webster, Texas, United States, 77598

Texas Oncology - Central South

Recruiting

Weslaco, Texas, United States, 78596

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

Recruiting

Blacksburg, Virginia, United States, 24060

Virginia Cancer Specialists, PC

Recruiting

Fairfax, Virginia, United States, 22031

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

Recruiting

Low Moor, Virginia, United States, 24457

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

Recruiting

Roanoke, Virginia, United States, 24014

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

Recruiting

Salem, Virginia, United States, 24153

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

Recruiting

Wytheville, Virginia, United States, 24382

Northwest Cancer Specialists, P.C.

Recruiting

Vancouver, Washington, United States, 98684

Minnesota Oncology Hematology, P.A.

Recruiting

Hudson, Wisconsin, United States, 54016

More Information

Sponsor

Pfizer

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Keywords

Renal cell carcinoma
renal cancer
renal neoplasm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-07-06.