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
- Berlin, Dresden, Essen, Frankfurt am Main, Freiburg im Breisgau, Halle Saale, Hanover, Heidelberg, Leipzig, Luebeck, Marburg, Rostock, and Ulm, GermanySee the 14 sites
- Phase
- Phase 3
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- HELIOS Klinikum Berlin Buch GmbHBerlin, GermanyTaking people
- Technische Universitaet DresdenDresden, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Krankenhaus Nordwest GmbHFrankfurt am Main, GermanyTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
- Universitaetsklinikum Halle (Saale) AöRHalle Saale, GermanyTaking people
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
- Universitaet LeipzigLeipzig, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRLuebeck, GermanyTaking people
- Philipps-Universitaet MarburgMarburg, GermanyTaking people
- Rostock University Medical CenterRostock, GermanyTaking people
- Universitaetsklinikum Ulm AoRUlm, GermanyTaking 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.