A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Status: Recruiting
Location: See all (116) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.
• A Karnofsky Performance Status (KPS) score ≥ 80%
• At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.
• Adequate organ and marrow function, ≤ 1 week prior to randomization.
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
Locations
United States
Arizona
Research Site
RECRUITING
Gilbert
Research Site
RECRUITING
Goodyear
Research Site
RECRUITING
Phoenix
California
Research Site
RECRUITING
Duarte
Research Site
RECRUITING
La Jolla
Research Site
RECRUITING
Los Angeles
Research Site
RECRUITING
Sacramento
Research Site
RECRUITING
San Diego
Connecticut
Research Site
RECRUITING
New Haven
Florida
Research Site
RECRUITING
Jacksonville
Research Site
RECRUITING
Miami
Research Site
RECRUITING
Orlando
Georgia
Research Site
RECRUITING
Atlanta
Research Site
RECRUITING
Atlanta
Research Site
RECRUITING
Newnan
Illinois
Research Site
RECRUITING
Zion
Indiana
Research Site
RECRUITING
Indianapolis
Kentucky
Research Site
RECRUITING
Louisville
Louisiana
Research Site
RECRUITING
Jefferson
Massachusetts
Research Site
RECRUITING
Boston
Research Site
RECRUITING
Boston
Maryland
Research Site
RECRUITING
Baltimore
Minnesota
Research Site
RECRUITING
Rochester
Missouri
Research Site
RECRUITING
St Louis
North Carolina
Research Site
RECRUITING
Chapel Hill
Nebraska
Research Site
RECRUITING
Omaha
New Jersey
Research Site
RECRUITING
New Brunswick
New York
Research Site
RECRUITING
Buffalo
Research Site
RECRUITING
Rochester
Ohio
Research Site
RECRUITING
Cleveland
Oregon
Research Site
RECRUITING
Portland
Pennsylvania
Research Site
RECRUITING
Monroeville
South Carolina
Research Site
RECRUITING
Charleston
Tennessee
Research Site
RECRUITING
Nashville
Research Site
RECRUITING
Nashville
Texas
Research Site
RECRUITING
Dallas
Research Site
RECRUITING
Lubbock
Utah
Research Site
RECRUITING
Salt Lake City
Virginia
Research Site
RECRUITING
Charlottesville
Washington
Research Site
RECRUITING
Seattle
Other Locations
Australia
Research Site
RECRUITING
Chermside
Research Site
RECRUITING
Elizabeth Vale
Research Site
RECRUITING
Frankston
Research Site
RECRUITING
Heidelberg
Research Site
RECRUITING
Hobart
Research Site
RECRUITING
Kurralta Park
Research Site
RECRUITING
Subiaco
Research Site
RECRUITING
Westmead
Canada
Research Site
RECRUITING
Montreal
Research Site
RECRUITING
Sherbrooke
Research Site
RECRUITING
Toronto
France
Research Site
RECRUITING
Angers
Research Site
RECRUITING
Brest
Research Site
RECRUITING
Caen
Research Site
RECRUITING
Montpellier
Research Site
RECRUITING
Paris
Research Site
RECRUITING
Poitiers
Research Site
RECRUITING
Rennes
Research Site
RECRUITING
Strasbourg
Research Site
RECRUITING
Villejuif
Germany
Research Site
RECRUITING
Berlin
Research Site
RECRUITING
Dresden
Research Site
RECRUITING
Frankfurt
Research Site
RECRUITING
Freiburg Im Breisgau
Research Site
RECRUITING
Halle
Research Site
RECRUITING
Hanover
Research Site
RECRUITING
Marburg
Research Site
RECRUITING
Rostock
Italy
Research Site
RECRUITING
Milan
Research Site
RECRUITING
Terni
Research Site
RECRUITING
Verona
Japan
Research Site
RECRUITING
Akita
Research Site
RECRUITING
Kobe
Research Site
RECRUITING
Matsuyama
Netherlands
Research Site
RECRUITING
Maastricht
Research Site
RECRUITING
Nijmegen
Research Site
RECRUITING
Rotterdam
Research Site
RECRUITING
Utrecht
Research Site
RECRUITING
Zwolle
New Zealand
Research Site
RECRUITING
Auckland
Research Site
RECRUITING
Christchurch
Research Site
RECRUITING
Hamilton
Research Site
RECRUITING
Rotorua
Poland
Research Site
RECRUITING
Krakow
Research Site
RECRUITING
Otwock
Research Site
RECRUITING
Poznan
Research Site
RECRUITING
Rzeszów
Research Site
RECRUITING
Skorzewo
Research Site
RECRUITING
Tomaszów Mazowiecki
Republic of Korea
Research Site
RECRUITING
Busan
Research Site
RECRUITING
Daejeon
Research Site
RECRUITING
Goyang
Research Site
RECRUITING
Seongnam
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Suwon
Romania
Research Site
RECRUITING
Craiova
Research Site
RECRUITING
Suceava
Research Site
RECRUITING
Timișoara
Spain
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Córdoba
Research Site
RECRUITING
Madrid
Research Site
RECRUITING
Málaga
Research Site
RECRUITING
Santander
Research Site
RECRUITING
Seville
Research Site
RECRUITING
Vigo
United Kingdom
Research Site
RECRUITING
Cambridge
Research Site
RECRUITING
Cottingham
Research Site
RECRUITING
Exeter
Research Site
RECRUITING
Glasgow
Research Site
RECRUITING
Leeds
Research Site
RECRUITING
London
Research Site
RECRUITING
Manchester
Research Site
RECRUITING
Preston
Research Site
RECRUITING
Southampton
Research Site
RECRUITING
Sutton
Research Site
RECRUITING
Truro
Contact Information
Primary
Medical Director
clinicaltrials@arcusbio.com
+1-510-462-3330
Time Frame
Start Date: 2025-09-08
Estimated Completion Date: 2030-12
Participants
Target number of participants: 720
Treatments
Experimental: Arm A (Experimental Arm)
Casdatifan and cabozantinib taken orally
Placebo_comparator: Arm B (Comparator Arm)
Placebo and cabozantinib taken orally
Related Therapeutic Areas
Sponsors
Leads: Arcus Biosciences, Inc.