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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07227415

Registry updated: 2026-10-08
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Description

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.

Interventions

  • PF-08634404 (Drug)
    Concentrate for solution for infusion
  • Ipilimumab (Drug)
    Solution for infusion
  • Axitinib (Drug)
    Tablet
  • Casdatifan (Drug)
    Tablet

Eligibility criteria

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

Conditions

Carcinoma, Renal Cell Advanced Renal Cell Carcinoma Renal Cancer Renal Neoplasm Clear Cell Renal Cell Carcinoma Metastatic Renal Cell Carcinoma Clear-cell Metastatic Renal Cell Carcinoma Carcinoma, Renal Cell Metastasis Advanced or Metastatic Renal Cell Carcinoma Carcinoma, Renal Cell, Advanced Metastatic Renal Cell Cancer Metastatic Renal Cell Carcinoma ( mRCC) Metastatic/Advanced Renal Cell Carcinoma

Locations

  • Mayo Clinic Building- Phoenix — Phoenix, Arizona, United States
  • Mayo Clinic Arizona — Scottsdale, Arizona, United States
  • Highlands Oncology Group — Fayetteville, Arkansas, United States
  • Highlands Oncology Group — Rogers, Arkansas, United States
  • Highlands Oncology Group, PA — Springdale, Arkansas, United States
  • UCLA Hematology/Oncology - Alhambra — Alhambra, California, United States
  • UCLA Hematology/Oncology - Atascadero — Atascadero, California, United States
  • UCLA Hematology/Oncology - Burbank — Burbank, California, 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
  • UC San Diego Medical Center - Encinitas — Encinitas, California, United States
  • UCLA Hematology/Oncology- Encino — Encino, California, United States
  • UCLA Hematology/Oncology- Irvine — Irvine, California, United States
  • City of Hope at Irvine Lennar — Irvine, California, United States
  • City of Hope Investigational Drug Services (IDS) — Irvine, California, United States
  • UC San Diego / Moores Cancer Center — La Jolla, California, United States
  • UC San Diego Koman Family Outpatient Pavilion — La Jolla, California, United States
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) — La Jolla, California, United States
  • UC San Diego Sulpizio Cardiovascular Center — La Jolla, California, United States
  • UCLA Hematology/Oncology - Laguna Hills — Laguna Hills, California, United States
  • City of Hope — Long Beach, California, United States
  • Investigational Drug Services, Bowyer Pharmacy — Los Angeles, California, United States
  • Ronald Reagan UCLA Medical Center, Drug Information Center — Los Angeles, California, United States
  • UCLA Hematology/Oncology — Los Angeles, California, United States
  • UCLA Hematology/Oncology - Marina del Rey — Marina del Rey, California, United States
  • UCLA Hematology/Oncology - Pasadena — Pasadena, California, United States
  • UCLA Hematology/Oncology - Porter Ranch — Porter Ranch, California, United States
  • UC San Diego Medical Center - Bankers Hill — San Diego, California, United States
  • UC San Diego McGrath Outpatient Pavilion - Hillcrest — San Diego, California, United States
  • UC San Diego Medical Center - Hillcrest — San Diego, California, United States
  • UC San Diego Medical Center - Rancho Bernardo — San Diego, California, United States
  • UCLA Hematology/Oncology - San Luis Obispo — San Luis Obispo, California, United States
  • UCLA Hematology/Oncology- Santa Barbara — Santa Barbara, California, United States
  • UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States
  • UCLA Hematology/Oncology- Torrance — Torrance, California, United States
  • City of Hope UPLAND — Upland, California, United States
  • UCLA Hematology/Oncology - Santa Clarita — Valencia, California, United States
  • UCLA Hematology/Oncology- Ventura — Ventura, California, United States
  • UC San Diego Medical Center - Vista — Vista, California, United States
  • UCLA Hematology/Oncology- Westlake — Westlake Village, California, United States
  • Rocky Mountain Cancer Centers,LLP — Aurora, Colorado, United States
  • Clinical and Translational Research Center(CTRC) — Aurora, Colorado, United States
  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) — Aurora, Colorado, United States
  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) — Aurora, Colorado, United States
  • University of Colorado Hospital-Anschutz Cancer Pavilion (ACP) — Aurora, Colorado, United States
  • UCHealth Cherry Creek Medical Center — Denver, Colorado, United States
  • Rocky Mountain Cancer Centers,LLP — Denver, Colorado, United States
  • Highlands Ranch Hospital — Highlands Ranch, Colorado, United States
  • Rocky Mountain Cancer Centers, LLP — Lakewood, Colorado, United States
  • Rocky Mountain Cancer Centers,LLP — Lone Tree, Colorado, United States
  • UC Health Lone Tree Medical Center — Lone Tree, Colorado, United States
  • Mayo Clinic Pharmacy — Jacksonville, Florida, United States
  • Orlando Health Cancer Institute — Lake Mary, Florida, United States
  • Orlando Health Ambulatory Care Center — Orlando, Florida, United States
  • Orlando Health Cancer Institute — Orlando, Florida, United States
  • Orlando Health Orlando Regional Medical Center — Orlando, Florida, United States
  • Tennessee Oncology, PLLC- Ringgold — Ringgold, Georgia, United States
  • Memorial Hospital — Shiloh, Illinois, United States
  • Siteman Cancer Center - Shiloh — Shiloh, Illinois, United States
  • City Of Hope - Chicago — Zion, Illinois, United States
  • Brigham and Women's Hospital — Boston, Massachusetts, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • Dana-Farber Cancer Institute - Chestnut Hill — Newton, Massachusetts, 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
  • Mayo Clinic Hospital, Methodist Campus, Research Pharmacy — Rochester, Minnesota, United States
  • Mayo Clinic Cancer Center Outpatient Pharmacy — Rochester, Minnesota, United States
  • Minnesota Oncology Hematology, P.A. — Woodbury, Minnesota, United States
  • Siteman Cancer Center - St. Peters — City of Saint Peters, Missouri, United States
  • Siteman Cancer Center - West County — Creve Coeur, Missouri, United States
  • Siteman Cancer Center - North County — Florissant, Missouri, United States
  • Siteman Cancer Center — St Louis, Missouri, United States
  • Barnes-Jewish Hospital — St Louis, Missouri, United States
  • Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri, United States
  • Siteman Cancer Center - South County — St Louis, Missouri, 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
  • Icahn School of Medicine at Mount Sinai — New York, 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
  • Northwest Cancer Specialists, P.C. — Portland, Oregon, 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
  • Henry-Joyce Cancer Clinic — 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 - Central South — Austin, Texas, United States
  • Texas Oncology - Central South — Austin, Texas, United States
  • Texas Oncology - Gulf Coast — Beaumont, Texas, United States
  • The University of Texas, MD Anderson Cancer Center - Conroe — Conroe, Texas, United States
  • University of Texas Southwestern Medical Center - Simmons Cancer Center — Dallas, Texas, United States
  • University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital — Dallas, Texas, United States
  • University of Texas Southwestern Simmons Cancer Center - Redbird — Dallas, Texas, United States
  • University of Texas Southwestern Medical Center-Zale Lipshy University Hospital — Dallas, Texas, United States
  • UT Southwestern Medical Center — Dallas, Texas, United States
  • University of Texas Southwestern Simmons Cancer Center - Fort Worth — Fort Worth, Texas, United States
  • Texas Oncology - Central South — Harlingen, Texas, United States
  • Texas Oncology - Gulf Coast — Houston, Texas, United States
  • University of Texas MD Anderson Cancer Center — Houston, Texas, United States
  • Texas Oncology - Gulf Coast — Houston, Texas, United States
  • The University of Texas, MD Anderson Cancer Center - West Houston — Houston, Texas, United States
  • US Oncology Investigational Products Center (IPC) — Irving, Texas, United States
  • US Oncology Investigational Products Center — Irving, Texas, United States
  • The University of Texas, MD Anderson Cancer Center - League City — League City, Texas, United States
  • Texas Oncology - Central South — McAllen, Texas, United States
  • Texas Oncology - Gulf Coast — Pearland, Texas, United States
  • University of Texas Southwestern Simmons Cancer Center - Richardson/Plano — Richardson, Texas, United States
  • The University of Texas, MD Anderson Cancer Center - Sugar Land — Sugar Land, Texas, United States
  • Texas Oncology - Gulf Coast — Sugar Land, Texas, United States
  • Texas Oncology - Gulf Coast — The Woodlands, Texas, United States
  • Texas Oncology - Central South — Waco, Texas, United States
  • Texas Oncology - Gulf Coast — Webster, Texas, United States
  • Texas Oncology - Central South — Weslaco, 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
  • Fred Hutchinson Cancer Center — Seattle, Washington, United States
  • University Of Washington Medical Center — Seattle, Washington, United States
  • Northwest Cancer Specialists, P.C. — Vancouver, Washington, United States
  • Minnesota Oncology Hematology, P.A. — Hudson, Wisconsin, United States
  • Icon Cancer Centre Wesley — Auchenflower, Queensland, Australia
  • Monash Health — Clayton, Victoria, Australia
  • Beijing Cancer hospital — Beijing, Beijing Municipality, China
  • Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China
  • Hunan Cancer Hospital — Changsha, Hunan, China
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China
  • Qilu Hospital of Shandong University — Jinan, Shandong, China
  • The first affiliated hospital of Ningbo university — Ningbo, Zhejiang, China
  • Heidelberg University Hospital — Heidelberg, Baden-Wurttemberg, Germany
  • Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden, Saxony, Germany
  • Charité Universitaetsmedizin Berlin — Berlin, Germany
  • 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
  • Hospital de la Santa Creu i Sant Pau — Barcelona, Catalunya [cataluña], Spain
  • Hospital Universitario Virgen de la Victoria — Málaga, Málaga, Spain
  • Vall d'Hebron Institute of Oncology (VHIO) — Barcelona, Spain
  • Hospital Clinico San Carlos — Madrid, Spain
  • Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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