Metastatic Clear Cell Renal Cell CarcinomaPhase 3NCT07011719

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

A Phase 3 study testing Casdatifan and Cabozantinib in people with Metastatic Clear Cell Renal Cell Carcinoma and Advanced Clear Cell Renal Cell Carcinoma, run by Arcus Biosciences, Inc. at 191 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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 for patients who received anti-PD-1 or anti-PD-L1 therapy as part of the most recent regimen (either adjuvant monotherapy or first-line in combination with… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
What is being tested?: Casdatifan and Cabozantinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 720 participants
Where: 191 sitesin 17 countries
Study dates: 8 Sep 2025to Dec 2030
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

191 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Medical Director contact

+1-510-462-3330

clinicaltrials@arcusbio.com

Country

City, postcode or hospital

Sites recruiting now only

191 sites in 17 countries

United States46 sites, 46 recruiting

Research Site
Atlanta, Georgia, 30318
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Atlanta, Georgia, 30322
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Aurora, Colorado, 80045
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Baltimore, Maryland, 21287
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Boston, Massachusetts, 02114
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Boston, Massachusetts, 02215
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Buffalo, New York, 14263
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Chapel Hill, North Carolina, 27514
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Charleston, South Carolina, 29425
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Charlottesville, Virginia, 22903
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Cleveland, Ohio, 44106
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Dallas, Texas, 75390
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Duarte, California, 91010
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Durham, North Carolina, 27710
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Gilbert, Arizona, 85234
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Goodyear, Arizona, 85338
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Indianapolis, Indiana, 46202
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Irvine, California, 91304
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Jacksonville, Florida, 32224
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Jefferson, Louisiana, 70121
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La Jolla, California, 92103
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Los Angeles, California, 90095
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Louisville, Kentucky, 40207
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Lubbock, Texas, 79430
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Miami, Florida, 33136
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Monroeville, Pennsylvania, 15146
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Nashville, Tennessee, 37203
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Nashville, Tennessee, 37232
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New Brunswick, New Jersey, 08903
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New Haven, Connecticut, 06519
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New York, New York, 10461
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Newnan, Georgia, 30265
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Omaha, Nebraska, 68198
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Orlando, Florida, 32804
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Palo Alto, California, 94304
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Phoenix, Arizona, 85054
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Portland, Oregon, 97212
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Rochester, Minnesota, 55905
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Rochester, New York, 14642
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Sacramento, California, 95817
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Salt Lake City, Utah, 84112
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San Diego, California, 92103
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Seattle, Washington, 98109
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St Louis, Missouri, 63110
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Washington D.C., District of Columbia, 20057
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Zion, Illinois, 60099
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Japan18 sites, 18 recruiting

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Akita
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Asahikawa
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Fukuoka
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Hidaka
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Hiroshima
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Kobe
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Kumamoto
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Kurume
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Matsuyama
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Nagoya
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Nankoku
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Niigata
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Okayama
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Osaka
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Sapporo
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Shinjuku
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Tokyo
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Yokohama
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France15 sites, 15 recruiting

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Angers
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Brest
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Caen
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Clermont-Ferrand
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Lille
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Marseille
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Montpellier
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Paris
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Pessac
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Poitiers
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Reims
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Rennes
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Toulouse
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Villejuif
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Australia14 sites, 14 recruiting

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Box Hill
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Chermside
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Elizabeth Vale
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Frankston
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Frenchs Forest
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Heidelberg
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Hobart
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Kurralta Park
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Macquarie Park
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New South Wales
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South Brisbane
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St Albans
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Subiaco
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Westmead
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United Kingdom14 sites, 14 recruiting

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Exeter
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Glasgow
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Leeds
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Manchester
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Preston
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Southampton
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Sutton
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Truro
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Whitchurch
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Germany13 sites, 13 recruiting

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Berlin
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Dresden
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Essen
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Frankfurt
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Freiburg im Breisgau
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Halle
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Hanover
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Heidelberg
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Leipzig
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Lübeck
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Rostock
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Ulm
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Italy12 sites, 12 recruiting

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Naples
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Rozzano
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Verona
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Poland9 sites, 9 recruiting

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Poznan
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Rzeszów
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Skorzewo
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Wroclaw
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Spain9 sites, 9 recruiting

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Madrid
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Málaga
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Pamplona
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Santander
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Seville
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Vigo
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Canada8 sites, 8 recruiting

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Hamilton
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Montreal
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Sherbrooke
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Toronto
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Vancouver
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Argentina6 sites, 6 recruiting

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Buenos Aires
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Córdoba
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La Plata
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Pilar
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Rosario
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Viedma
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Netherlands6 sites, 6 recruiting

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Amsterdam
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Nijmegen
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Rotterdam
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Utrecht
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Zwolle
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South Korea6 sites, 6 recruiting

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Busan
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Daejeon
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Goyang
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Seongnam
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Seoul
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Suwon
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Czechia5 sites, 5 recruiting

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Brno
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Hradec
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Romania5 sites, 5 recruiting

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Suceava
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Timișoara
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New Zealand4 sites, 4 recruiting

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Singapore1 site, 1 recruiting

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About this study

Official title: 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

Conditions: Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
Being tested: Casdatifan, Cabozantinib, Placebo
Keywords: Casdatifan, Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma, Kidney Cancer, PEAK-1, AB521, ccRCC, Anti-PD-1, Anti-PD-L1, HIF-2α, HIF-2α inhibitor
Medical subject headings: Clear-cell metastatic renal cell carcinoma, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CasdatifanDrug
Also called AB521
Administered as specified in the treatment arm
CabozantinibDrug
Administered as specified in the treatment arm
PlaceboDrug
Administered as specified in the treatment arm

Study groups in NCT07011719
Study group	Role	What they receive
Arm A (Experimental Arm)	Experimental	Casdatifan and cabozantinib taken orally Receives: Drug: Casdatifan; Drug: Cabozantinib
Arm B (Comparator Arm)	Placebo comparator	Placebo and cabozantinib taken orally Receives: Drug: Cabozantinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
Measured: up to approximately 33 months

Secondary outcomes (6)

Overall Survival (OS)
Measured: up to approximately 64 months
Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
Measured: up to approximately 33 months
Duration of Response (DOR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
Measured: up to approximately 33 months
Disease Control Rate (DCR) by Blinded Independent Central Review (BICR)
Measured: up to approximately 33 months
The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs)
Measured: up to approximately 33 months
Time to first symptom deterioration in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (NFKSI-DRS) Items 1-9 sub-scale score.
Measured: up to approximately 33 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 2025Dec 2030

First posted10 Jun 2025
Study start8 Sep 2025
Primary completionApr 2028 (estimated)
Study completionDec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metastatic Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 720 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07011719
Sponsor's protocol ID: PEAK-1
Other IDs: 2024-515023-11-00
Status last verified: Apr 2026
First submitted: 2 Jun 2025
Last updated: 2 Nov 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

Publications

Mailyan AK, Mata G, Beatty JW, Drew SL, Fournier J, Yu K, Gal B, Kalisiak J, Yan X, Tran A, Su Y, Rosen BR, Jeffrey JL, Hardman C, Epplin M, Ginn E, Sun M, Chen A, Fabila P, Sivick KE, Schweickert PG, Piovesan D, Meleza C, Pham AT, Chen PY, Jin L, Walters MJ, Walker NP, Kwon HJ, Leleti MR, Powers JP, Lawson KV. Discovery of Casdatifan, Part II: A Potent and Orally Bioavailable Inhibitor of Hypoxia Inducible Factor-2alpha. J Med Chem. 2026 Jun 25;69(12):14952-14988. doi: 10.1021/acs.jmedchem.5c03724. Epub 2026 Jun 5.
PubMed 42246926

Interested in taking part?

Medical Director

+1-510-462-3330

clinicaltrials@arcusbio.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Metastatic Clear Cell Renal Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07011719
Acronym / sponsor ID: PEAK-1
Conditions: Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
Keywords: Casdatifan, Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma, Kidney Cancer, PEAK-1, AB521, ccRCC, Anti-PD-1
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 720 participants (estimated)
Lead sponsor: Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
Study start: 8 Sep 2025 (actual)
Primary completion: Apr 2028 (estimated)
Study completion: Dec 2030 (estimated)
First posted: 10 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm A (Experimental Arm)	Experimental	Drug: Casdatifan, Drug: CabozantinibCasdatifan and cabozantinib taken orally
Arm B (Comparator Arm)	Placebo comparator	Drug: Cabozantinib, Drug: PlaceboPlacebo and cabozantinib taken orally

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CasdatifanAlso: AB521Administered as specified in the treatment arm	Drug	Arm A (Experimental Arm)
CabozantinibAdministered as specified in the treatment arm	Drug	Arm A (Experimental Arm), Arm B (Comparator Arm)
PlaceboAdministered as specified in the treatment arm	Drug	Arm B (Comparator Arm)

Primary outcome

Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
Time frame: up to approximately 33 months

6 secondary outcomes

Overall Survival (OS)
Time frame: up to approximately 64 months
Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
Time frame: up to approximately 33 months
Duration of Response (DOR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
Time frame: up to approximately 33 months
Disease Control Rate (DCR) by Blinded Independent Central Review (BICR)
Time frame: up to approximately 33 months
The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs)
Time frame: up to approximately 33 months
Time to first symptom deterioration in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (NFKSI-DRS) Items 1-9 sub-scale score.
Time frame: up to approximately 33 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Derived from this study: PubMed 42246926Mailyan AK, Mata G, Beatty JW, Drew SL, Fournier J, Yu K, Gal B, Kalisiak J, Yan X, Tran A, Su Y, Rosen BR, Jeffrey JL, Hardman C, Epplin M, Ginn E, Sun M, Chen A, Fabila P, Sivick KE, Schweickert PG, Piovesan D, Meleza C, Pham AT, Chen PY, Jin L, Walters MJ, Walker NP, Kwon HJ, Leleti MR, Powers JP, Lawson KV. Discovery of Casdatifan, Part II: A Potent and Orally Bioavailable Inhibitor of Hypoxia Inducible Factor-2alpha. J Med Chem. 2026 Jun 25;69(12):14952-14988. doi: 10.1021/acs.jmedchem.5c03724. Epub 2026 Jun 5.
Individual participant dataSharing planned: Yes. Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

Related trials for Metastatic Clear Cell Renal Cell Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Medical Director contact

+1-510-462-3330

clinicaltrials@arcusbio.com

Medical Director study director

Arcus Biosciences

191 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 191 sites in United States, Japan, France, Australia, United Kingdom and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical Director (+1-510-462-3330, clinicaltrials@arcusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 (time frame: up to approximately 33 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07011719, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.