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Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Received prior treatment with a HIF-2α inhibitor or cabozantinib.
* Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
* Ongoing clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies.
* Uncontrolled or poorly controlled hypertension, defined as a sustained blood pressure \> 150 mmHg systolic or \> 90 mmHg diastolic despite optimal antihypertensive treatment.
* History of leptomeningeal disease or spinal cord compression.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

About the study

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.

What is being tested

Sponsor: Arcus Biosciences, Inc. · Participants: 720 · Started: Sep 8, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07011719

Locations in the U.S.

ArizonaResearch Site, Gilbert
Research Site, Goodyear
Research Site, Phoenix
CaliforniaResearch Site, Duarte
Research Site, Irvine
Research Site, La Jolla
Research Site, Los Angeles
Research Site, Palo Alto
Research Site, Sacramento
Research Site, San Diego
ColoradoResearch Site, Aurora
ConnecticutResearch Site, New Haven
District of ColumbiaResearch Site, Washington D.C.
FloridaResearch Site, Jacksonville
Research Site, Miami
Research Site, Orlando
GeorgiaResearch Site, Atlanta
Research Site, Atlanta
Research Site, Newnan
IllinoisResearch Site, Zion
IndianaResearch Site, Indianapolis
KentuckyResearch Site, Louisville
LouisianaResearch Site, Jefferson
MarylandResearch Site, Baltimore
MassachusettsResearch Site, Boston
Research Site, Boston
MinnesotaResearch Site, Rochester
MissouriResearch Site, St Louis
NebraskaResearch Site, Omaha
New JerseyResearch Site, New Brunswick
New YorkResearch Site, Buffalo
Research Site, New York
Research Site, Rochester
North CarolinaResearch Site, Chapel Hill
Research Site, Durham
OhioResearch Site, Cleveland
OregonResearch Site, Portland
PennsylvaniaResearch Site, Monroeville
South CarolinaResearch Site, Charleston
TennesseeResearch Site, Nashville
Research Site, Nashville
TexasResearch Site, Dallas
Research Site, Lubbock
UtahResearch Site, Salt Lake City
VirginiaResearch Site, Charlottesville
WashingtonResearch Site, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.