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
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.
Who can participate
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
* Acute, chronic or symptomatic infections
* Participants with history of immunodeficiency
Interventions
PF-08634404
BIOLOGICAL
Combination 1
DRUG
Combination 2
DRUG
Locations
49
Australia (1)
Icon Cancer Centre Wesley
Auchenflower , Queensland
Japan (4)
National Hospital Organization Kyushu Cancer Center
Fukuoka
Keio university hospital
Shinjuku-ku , Tokyo
The University of Osaka Hospital
Suita , Osaka
NOT_YET_RECRUITING
Yamagata University Hospital
Yamagata
United States (44)
New York Oncology Hematology, P.C.
Albany , New York
NOT_YET_RECRUITING
Texas Oncology - Central South
Austin , Texas
Texas Oncology - Central South
Austin , Texas
Texas Oncology - Gulf Coast
Beaumont , Texas
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg , Virginia
Minnesota Oncology Hematology, P.A.
Burnsville , Minnesota
Minnesota Oncology Hematology, P.A.
Chaska , Minnesota
New York Oncology Hematology - Clifton Park Cancer Center
Clifton Park , New York
NOT_YET_RECRUITING
Minnesota Oncology Hematology, P.A.
Coon Rapids , Minnesota
Rocky Mountain Cancer Centers, LLP
Denver , Colorado
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte , California
City of Hope Investigational Drug Services (IDS)
Duarte , California
Minnesota Oncology Hematology, P.A.
Edina , Minnesota
Virginia Cancer Specialists, PC
Fairfax , Virginia
Highlands Oncology Group
Fayetteville , Arkansas
Texas Oncology - Gulf Coast
Houston , Texas
Texas Oncology - Gulf Coast
Houston , Texas
Minnesota Oncology Hematology, P.A.
Hudson , Wisconsin
City of Hope Investigational Drug Services (IDS)
Irvine , California
City of Hope
Irvine , California
US Oncology Investigational Products Center (IPC)
Irving , Texas
US Oncology Investigational Products Center
Irving , Texas
City of Hope
Long Beach , California
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor , Virginia
Minnesota Oncology Hematology, P.A.
Maple Grove , Minnesota
Minnesota Oncology Hematology, P.A.
Maplewood , Minnesota
Texas Oncology - Central South
McAllen , Texas
Grand Strand Medical Center
Myrtle Beach , South Carolina
Carolina Urologic Research Center, LLC
Myrtle Beach , South Carolina
Parkway Surgery Center
Myrtle Beach , South Carolina
Sarah Cannon Research Institute
Nashville , Tennessee
SCRI Oncology Partners
Nashville , Tennessee
Texas Oncology - Gulf Coast
Pearland , Texas
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke , Virginia
Highlands Oncology Group
Rogers , Arkansas
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem , Virginia
Highlands Oncology Group
Springdale , Arkansas
Texas Oncology - Gulf Coast
Sugar Land , Texas
Texas Oncology - Gulf Coast
The Woodlands , Texas
City of Hope UPLAND
Upland , California
Texas Oncology - Gulf Coast
Webster , Texas
Minnesota Oncology Hematology, P.A.
Woodbury , Minnesota
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
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