An official website of the United States government
NIH Websites Are Changing Per Executive Order 14434, federal agencies are now using "Super Intelligence" (SI) in place of "Artificial Intelligence" (AI). You may see both terms across NIH content during this transition.
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
Trial Status: active
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.
Inclusion 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07227415.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not Available
Colorado
Aurora
UCHealth University of Colorado Hospital
Status: Approved
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Massachusetts
Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Texas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not Available
Houston
UT MD Anderson Cancer Center
Status: Approved
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium