Tests casdatifan with cabozantinib in advanced kidney cancer
Tests casdatifan plus cabozantinib against placebo in adults with advanced clear cell kidney cancer.
Plain-language title generated from the registry record
Registry title: Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Key facts
- Where
- Budapest VI, Budapest XII, Debrecen, Győr, Gyula, Kecskemét, and Szeged, HungarySee the 7 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with clear cell kidney cancer that cannot be removed by surgery and is advanced or has spread. They must have had anti-PD-1 or anti-PD-L1 treatment in their most recent regimen.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Clear cell kidney cancer (renal cell carcinoma) that is locally advanced or has spread, cannot be removed by surgery, and can be measured on scans. At least 1 target lesion on CT or MRI, not in an area that had radiation. No more than 1 earlier regimen for spread disease.
- Earlier treatment
- The most recent regimen must have included anti-PD-1 or anti-PD-L1 treatment, either alone after surgery or as first-line treatment together with anti-CTLA-4 or VEGFR-TKI. No earlier treatment with a HIF-2α inhibitor or cabozantinib.
Main reasons for not taking part
- Earlier treatment with a HIF-2α inhibitor or cabozantinib
- Another cancer that was active in the past year, except locally treatable cancers that appear to be fully removed
- Ongoing significant side effects from earlier cancer treatment, or side effects of Grade 3 or higher
- High blood pressure that stays above 150 mmHg systolic or 90 mmHg diastolic despite treatment
- History of cancer spread to the brain and spinal fluid lining, or spinal cord compression
Read by machine on 9 November 2026.
Where in Hungary
- Central Hospital Of Northern Pest Military HospitalBudapest VI, HungaryTaking people
- Orszagos Onkologiai IntezetBudapest XII, HungaryTaking people
- University of DebrecenDebrecen, HungaryTaking people
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato KorhazGyőr, HungaryTaking people
- Bekes Varmegyei Koezponti KorhazGyula, HungaryTaking people
- Bacs-Kiskun Varmegyei OktatokorhazKecskemét, HungaryTaking people
- University of SzegedSzeged, HungaryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Arcus Biosciences, Inc.
- Trial code
- NCT07011719EU 2024-515023-11-00
- Record updated
- 2 November 2026
- Original description
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 anti-CTLA-4 or VEGFR-TKI), with no more than 1 prior regimen in the metastatic setting.Read full original descriptionShow less
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
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 anti-CTLA-4 or VEGFR-TKI), with no more than 1 prior regimen in the metastatic setting.
Inclusion: 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: Received prior treatment with a HIF-2α inhibitor or cabozantinib; 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; Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured; 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.