Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Arcus Biosciences, Inc. (Voir sur ClinicalTrials)
septembre 2025
décembre 2030
27 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Laurence ALBIGES | 15/09/2026 13:45:06 | Contacter | ||
Critères
Tous
- 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.