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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
(PEAK-1)

Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma (PEAK-1)

Nasermoaddeli Ali

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

yuji-yamamoto@taiho.co.jp

Yamamoto Yuji

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

+81-3-3294-4527

yuji-yamamoto@taiho.co.jp

Recruiting

May. 29, 2026

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

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

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.

Both

Advanced or metastatic clear cell renal cell carcinoma (ccRCC)

Arm A (Experimental Arm)
Casdatifan and cabozantinib taken orally.

Arm B (Comparator Arm)
Placebo and cabozantinib taken orally.

Progression-free Survival (PFS)

- 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.

+81-22-346-0325

Yes

We 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.

United States/France/Netherlands/Poland/Romania/South Korea/United Kingdom/New Zealand/Australia/Spain/Italy/Czech/Germa/Canada