NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Advanced or metastatic clear cell renal cell carcinoma (ccRCC)
Date of first enrollment	29/05/2026
Target sample size	65
Countries of recruitment	United States,Japan,France,Japan,Netherlands,Japan,Poland,Japan,Romania,Japan,South Korea,Japan,United Kingdom,Japan,New Zealand,Japan,Australia,Japan,Spain,Japan,Italy,Japan,Czech,Japan,Germa,Japan,Canada,Japan
Study type	Interventional
Intervention(s)	Arm A (Experimental Arm) Casdatifan and cabozantinib taken orally. Arm B (Comparator Arm) Placebo and cabozantinib taken orally.

Outcome(s)

Primary Outcome

Progression-free Survival (PFS)

Secondary Outcome

- Overall survival (OS) - Objective response rate (ORR) - Duration of response (DoR) - Disease Control Rate (DCR) - The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs) - 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.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1.Unresectable locally advanced or metastatic renal cell carcinoma with a primary clear cell component. 2.A Karnofsky Performance Status (KPS) score >= 80% 3.At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy. 4.Adequate organ and marrow function, =< 1 week prior to randomization. 5.Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
Exclude criteria	1. Received prior treatment with a HIF-2alpha inhibitor or cabozantinib. 2. Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured. 3. 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. 4. Uncontrolled or poorly controlled hypertension defined as a sustained blood pressure >150 mmHg systolic or >90 mmHg diastolic despite optimal antihypertensive treatment. 5. History of leptomeningeal disease or spinal cord compression.