AzTrials
AzTrials

Carcinoma, Renal CellPhase 1/2NCT07227415

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

A Phase 1/2 study testing PF-08634404, Ipilimumab and Axitinib in people with Carcinoma, Renal Cell and Advanced Renal Cell Carcinoma, run by Pfizer at 183 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-08634404, Ipilimumab and Axitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
183 sitesin 6 countries
Study dates
10 Feb 2026to 1 Nov 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

183 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

183 sites in 6 countries

United States160 sites, 160 recruiting

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

    Recruiting

  • UCLA Hematology/Oncology - Alhambra

    Alhambra, California, 91801

    Not yet recruiting

  • UCLA Hematology/Oncology - Atascadero

    Atascadero, California, 93422

    Not yet recruiting

  • Rocky Mountain Cancer Centers,LLP

    Aurora, Colorado, 80012

    Recruiting

  • Clinical and Translational Research Center(CTRC)

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado Hospital-Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045

    Recruiting

  • Texas Oncology - Central South

    Austin, Texas, 78705

    Recruiting

  • Texas Oncology - Central South

    Austin, Texas, 78731

    Recruiting

  • Texas Oncology - Central South

    Austin, Texas, 78745

    Recruiting

  • Texas Oncology - Central South

    Austin, Texas, 78758

    Recruiting

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920

    Recruiting

  • Texas Oncology - Gulf Coast

    Beaumont, Texas, 77702

    Recruiting

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

    Blacksburg, Virginia, 24060

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • UCLA Hematology/Oncology - Burbank

    Burbank, California, 91505

    Not yet recruiting

  • Minnesota Oncology Hematology, P.A.

    Burnsville, Minnesota, 55337

    Recruiting

  • Minnesota Oncology Hematology, P.A.

    Chaska, Minnesota, 55318

    Recruiting

  • Tennessee Oncology, PLLC- Chattanooga Downtown

    Chattanooga, Tennessee, 37403

    Recruiting

  • Tennessee Oncology, PLLC - Chattanooga Med Park II

    Chattanooga, Tennessee, 37404

    Recruiting

  • Tennessee Oncology, PLLC - Chattanooga Memorial

    Chattanooga, Tennessee, 37404

    Recruiting

  • Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage

    Chattanooga, Tennessee, 37404

    Recruiting

  • Tennessee Oncology, PLLC- Chattanooga East

    Chattanooga, Tennessee, 37421

    Recruiting

  • Siteman Cancer Center - St. Peters

    City of Saint Peters, Missouri, 63376

    Recruiting

  • New York Oncology Hematology - Clifton Park Cancer Center

    Clifton Park, New York, 12065

    Recruiting

  • MSK Commack

    Commack, New York, 11725

    Recruiting

  • The University of Texas, MD Anderson Cancer Center - Conroe

    Conroe, Texas, 77384

    Not yet recruiting

  • Tennessee Oncology, PLLC- Cookeville

    Cookeville, Tennessee, 38501

    Recruiting

  • Minnesota Oncology Hematology, P.A.

    Coon Rapids, Minnesota, 55433

    Recruiting

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141

    Recruiting

  • University of Texas Southwestern Medical Center - Simmons Cancer Center

    Dallas, Texas, 75235

    Recruiting

  • University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital

    Dallas, Texas, 75235

    Recruiting

  • University of Texas Southwestern Simmons Cancer Center - Redbird

    Dallas, Texas, 75237

    Recruiting

  • University of Texas Southwestern Medical Center-Zale Lipshy University Hospital

    Dallas, Texas, 75390

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • UCHealth Cherry Creek Medical Center

    Denver, Colorado, 80206

    Recruiting

  • Rocky Mountain Cancer Centers,LLP

    Denver, Colorado, 80218

    Recruiting

  • Tennessee Oncology, PLLC-Dickson

    Dickson, Tennessee, 37055

    Recruiting

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

    Duarte, California, 91010

    Recruiting

  • City of Hope Investigational Drug Services (IDS)

    Duarte, California, 91010

    Recruiting

  • Minnesota Oncology Hematology, P.A.

    Edina, Minnesota, 55435

    Recruiting

  • UC San Diego Medical Center - Encinitas

    Encinitas, California, 92024

    Recruiting

  • UCLA Hematology/Oncology- Encino

    Encino, California, 91436

    Not yet recruiting

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

    Recruiting

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

    Recruiting

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031

    Recruiting

  • University of Texas Southwestern Simmons Cancer Center - Fort Worth

    Fort Worth, Texas, 76104

    Recruiting

  • Tennessee Oncology, PLLC- Franklin Proton Center

    Franklin, Tennessee, 37067

    Recruiting

  • Tennessee Oncology, PLLC-Franklin

    Franklin, Tennessee, 37067

    Recruiting

  • Tennessee Oncology, PLLC-Gallatin

    Gallatin, Tennessee, 37066

    Recruiting

  • Texas Oncology - Central South

    Harlingen, Texas, 78550

    Recruiting

  • MSK Westchester

    Harrison, New York, 10604

    Recruiting

  • Tennessee Oncology, PLLC-Hendersonville

    Hendersonville, Tennessee, 37075

    Recruiting

  • Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

    Recruiting

  • Texas Oncology - Gulf Coast

    Houston, Texas, 77024

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Not yet recruiting

  • Texas Oncology - Gulf Coast

    Houston, Texas, 77054

    Recruiting

  • The University of Texas, MD Anderson Cancer Center - West Houston

    Houston, Texas, 77079

    Not yet recruiting

  • Minnesota Oncology Hematology, P.A.

    Hudson, Wisconsin, 54016

    Recruiting

  • UCLA Hematology/Oncology- Irvine

    Irvine, California, 92604

    Not yet recruiting

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Recruiting

  • City of Hope Investigational Drug Services (IDS)

    Irvine, California, 92618

    Recruiting

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063

    Recruiting

  • US Oncology Investigational Products Center

    Irving, Texas, 75063

    Recruiting

  • Mayo Clinic Pharmacy

    Jacksonville, Florida, 32224

    Recruiting

  • UC San Diego / Moores Cancer Center

    La Jolla, California, 92037

    Recruiting

  • UC San Diego Koman Family Outpatient Pavilion

    La Jolla, California, 92037

    Recruiting

  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

    La Jolla, California, 92037

    Recruiting

  • UC San Diego Sulpizio Cardiovascular Center

    La Jolla, California, 92037

    Recruiting

  • UCLA Hematology/Oncology - Laguna Hills

    Laguna Hills, California, 92653

    Not yet recruiting

  • Orlando Health Cancer Institute

    Lake Mary, Florida, 32746

    Recruiting

  • Rocky Mountain Cancer Centers, LLP

    Lakewood, Colorado, 80228

    Recruiting

  • The University of Texas, MD Anderson Cancer Center - League City

    League City, Texas, 77573

    Not yet recruiting

  • Tennessee Oncology, PLLC-Lebanon

    Lebanon, Tennessee, 37090

    Recruiting

  • Rocky Mountain Cancer Centers,LLP

    Lone Tree, Colorado, 80124

    Recruiting

  • UC Health Lone Tree Medical Center

    Lone Tree, Colorado, 80124

    Recruiting

  • City of Hope

    Long Beach, California, 90813

    Recruiting

  • Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

    Long Island City, New York, 11101

    Recruiting

  • Investigational Drug Services, Bowyer Pharmacy

    Los Angeles, California, 90095

    Not yet recruiting

  • Ronald Reagan UCLA Medical Center, Drug Information Center

    Los Angeles, California, 90095

    Not yet recruiting

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

    Not yet recruiting

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

    Low Moor, Virginia, 24457

    Recruiting

  • Minnesota Oncology Hematology, P.A.

    Maple Grove, Minnesota, 55369

    Recruiting

  • Minnesota Oncology Hematology, P.A.

    Maplewood, Minnesota, 55109

    Recruiting

  • UCLA Hematology/Oncology - Marina del Rey

    Marina del Rey, California, 90292

    Not yet recruiting

  • Texas Oncology - Central South

    McAllen, Texas, 78503

    Recruiting

  • MSK Monmouth

    Middletown, New Jersey, 07748

    Recruiting

  • MSK Bergen

    Montvale, New Jersey, 07645

    Recruiting

  • Tennessee Oncology, PLLC-Mount Juliet

    Mount Juliet, Tennessee, 37122

    Recruiting

  • Tennessee Oncology, PLLC-Murfreesboro

    Murfreesboro, Tennessee, 37129

    Recruiting

  • Grand Strand Medical Center

    Myrtle Beach, South Carolina, 295724607

    Recruiting

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Parkway Surgery Center

    Myrtle Beach, South Carolina, 29572

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Tennessee Oncology, PLLC- Elliston Place Plaza

    Nashville, Tennessee, 37203

    Recruiting

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

    Nashville, Tennessee, 37203

    Recruiting

  • Tennessee Oncology, PLLC-Investigational Drug Services

    Nashville, Tennessee, 37203

    Recruiting

  • Tennessee Oncology, PLLC- Saint Thomas West

    Nashville, Tennessee, 37205

    Recruiting

  • Tennessee Oncology, PLLC- Skyline

    Nashville, Tennessee, 37207

    Recruiting

  • Tennessee Oncology, PLLC- Southern Hills

    Nashville, Tennessee, 37211

    Recruiting

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Recruiting

  • Evelyn H. Lauder Breast and Imaging Center (BAIC)

    New York, New York, 10065

    Recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York, 10065

    Recruiting

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

    New York, New York, 10065

    Recruiting

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts, 02467

    Recruiting

  • Orlando Health Ambulatory Care Center

    Orlando, Florida, 32806

    Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

    Recruiting

  • Orlando Health Orlando Regional Medical Center

    Orlando, Florida, 32806

    Recruiting

  • UCLA Hematology/Oncology - Pasadena

    Pasadena, California, 91105

    Not yet recruiting

  • Texas Oncology - Gulf Coast

    Pearland, Texas, 77584

    Recruiting

  • Mayo Clinic Building- Phoenix

    Phoenix, Arizona, 85054

    Recruiting

  • UCLA Hematology/Oncology - Porter Ranch

    Porter Ranch, California, 91326

    Not yet recruiting

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97227

    Recruiting

  • University of Texas Southwestern Simmons Cancer Center - Richardson/Plano

    Richardson, Texas, 75080

    Recruiting

  • Tennessee Oncology, PLLC- Ringgold

    Ringgold, Georgia, 30736

    Recruiting

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

    Roanoke, Virginia, 24014

    Recruiting

  • Mayo Clinic Hospital, Methodist Campus, Research Pharmacy

    Rochester, Minnesota, 55902

    Recruiting

  • Mayo Clinic Cancer Center Outpatient Pharmacy

    Rochester, Minnesota, 55905

    Recruiting

  • Highlands Oncology Group

    Rogers, Arkansas, 72758

    Recruiting

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

    Salem, Virginia, 24153

    Recruiting

  • UC San Diego Medical Center - Bankers Hill

    San Diego, California, 92101

    Recruiting

  • UC San Diego McGrath Outpatient Pavilion - Hillcrest

    San Diego, California, 92103

    Recruiting

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

    Recruiting

  • UC San Diego Medical Center - Rancho Bernardo

    San Diego, California, 92127

    Recruiting

  • UCLA Hematology/Oncology - San Luis Obispo

    San Luis Obispo, California, 93401

    Not yet recruiting

  • UCLA Hematology/Oncology- Santa Barbara

    Santa Barbara, California, 93101

    Not yet recruiting

  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California, 90404

    Not yet recruiting

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • University Of Washington Medical Center

    Seattle, Washington, 98195

    Recruiting

  • Tennessee Oncology, PLLC- Shelbyville

    Shelbyville, Tennessee, 37160

    Recruiting

  • Memorial Hospital

    Shiloh, Illinois, 62269

    Recruiting

  • Siteman Cancer Center - Shiloh

    Shiloh, Illinois, 62269

    Recruiting

  • Tennessee Oncology, PLLC- Smyrna

    Smyrna, Tennessee, 37167

    Recruiting

  • Highlands Oncology Group, PA

    Springdale, Arkansas, 72762

    Recruiting

  • Siteman Cancer Center

    St Louis, Missouri, 63108

    Recruiting

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

    Recruiting

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110

    Recruiting

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

    Recruiting

  • The University of Texas, MD Anderson Cancer Center - Sugar Land

    Sugar Land, Texas, 77478

    Not yet recruiting

  • Texas Oncology - Gulf Coast

    Sugar Land, Texas, 77479

    Recruiting

  • Texas Oncology - Gulf Coast

    The Woodlands, Texas, 77380

    Recruiting

  • UCLA Hematology/Oncology- Torrance

    Torrance, California, 90505

    Not yet recruiting

  • MSK Nassau

    Uniondale, New York, 11553

    Recruiting

  • City of Hope UPLAND

    Upland, California, 91786

    Recruiting

  • UCLA Hematology/Oncology - Santa Clarita

    Valencia, California, 91355

    Not yet recruiting

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684

    Recruiting

  • UCLA Hematology/Oncology- Ventura

    Ventura, California, 93003

    Not yet recruiting

  • UC San Diego Medical Center - Vista

    Vista, California, 92081

    Recruiting

  • Texas Oncology - Central South

    Waco, Texas, 76712

    Recruiting

  • Texas Oncology - Gulf Coast

    Webster, Texas, 77598

    Recruiting

  • Texas Oncology - Central South

    Weslaco, Texas, 78596

    Recruiting

  • UCLA Hematology/Oncology- Westlake

    Westlake Village, California, 91361

    Not yet recruiting

  • Minnesota Oncology Hematology, P.A.

    Woodbury, Minnesota, 55125

    Recruiting

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

    Wytheville, Virginia, 24382

    Recruiting

  • City Of Hope - Chicago

    Zion, Illinois, 60099

    Recruiting

Other trials in United States

China7 sites, 7 recruiting

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Recruiting

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Recruiting

  • The first affiliated hospital of Ningbo university

    Ningbo, Zhejiang, 315010

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Recruiting

Other trials in China

Spain6 sites, 6 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalunya [cataluña], 08041

    Recruiting

  • Vall d'Hebron Institute of Oncology (VHIO)

    Barcelona, 08035

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

    Recruiting

Other trials in Spain

Japan5 sites, 5 recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

    Recruiting

  • Keio university hospital

    Shinjuku-ku, Tokyo, 1608582

    Recruiting

  • The University of Osaka Hospital

    Suita, Osaka, 565-0871

    Recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

    Recruiting

Other trials in Japan

Germany3 sites, 3 recruiting

  • Charité Universitaetsmedizin Berlin

    Berlin, 10117

    Not yet recruiting

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, Saxony, 01307

    Recruiting

  • Heidelberg University Hospital

    Heidelberg, Baden-Wurttemberg, 69120

    Not yet recruiting

Other trials in Germany

Australia2 sites, 2 recruiting

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, 4066

    Recruiting

  • Monash Health

    Clayton, Victoria, 3168

    Recruiting

Other trials in Australia

About this study

Official title: 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

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.

Being tested
PF-08634404, Ipilimumab, Axitinib, Casdatifan
Keywords
Renal cell carcinoma, renal cancer, renal neoplasm
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Clear-cell metastatic renal cell carcinoma, Carcinoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08634404Drug

    Also called SSGJ-707

    Concentrate for solution for infusion

  • IpilimumabDrug

    Also called yervoy

    Solution for infusion

  • AxitinibDrug

    Tablet

  • CasdatifanDrug

    Tablet

Study groups in NCT07227415
Study groupRoleWhat they receive
Cohort AExperimentalParticipants will receive PF-08634404 IV.
Receives: Drug: PF-08634404
Cohort BExperimentalParticipants will receive PF-08634404 in combination with ipilimumab.
Receives: Drug: PF-08634404; Drug: Ipilimumab
Cohort CExperimentalParticipants will receive PF-08634404 IV in combination with axitinib.
Receives: Drug: PF-08634404; Drug: Axitinib
Cohort DExperimentalParticipants will receive PF-08634404 in combination with Casdatifan.
Receives: Drug: PF-08634404; Drug: Casdatifan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 3 years

  2. 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.

    Measured: Through 90 days after the last study intervention (Up to approximately 3 years)

  3. 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).

    Measured: Though end of DLT evaluation period (Up to approximately 3 years)

Secondary outcomes (6)

  1. Duration of Response (DOR) per RECIST v1.1 by investigator

    DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.

    Measured: Up to approximately 3 years

  2. Progression Free Survival (PFS) per RECIST v1.1 by investigator

    Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.

    Measured: Up to approximately 3 years

  3. Overall Survival (OS)

    Overall survival defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Up to approximately 3 years

  4. Number of Participants With Clinical Laboratory Abnormalities

    laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing

    Measured: Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (approximately 3 years)

  5. Pharmacokinetics (PK): Serum concentration of PF-08634404

    Pre-dose and post dose concentrations of PF-08634404

    Measured: Up to 37 days after the last dose of treatment

  6. Incidence of Anti-Drug Antibody (ADA) against PF-08634404

    To evaluate the immunogenicity of PF-08634404

    Measured: Up to 37 days after the last dose of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2025
  2. Study start10 Feb 2026
  3. Primary completion2 Nov 2027 (estimated)
  4. Study completion1 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07227415
Sponsor's protocol ID
C6461008
Other IDs
2025-523524-53-00, Symbiotic-GU-08, 2025
Status last verified
Oct 2026
First submitted
7 Nov 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PF-08634404, Ipilimumab and Axitinib in people with Carcinoma, Renal Cell and Advanced Renal Cell Carcinoma, run by Pfizer at 183 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in United States, China, Spain, Japan, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator (time frame: Up to approximately 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07227415.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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