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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051260009

Enrollment

Registered

2026-04-06

Start date

2026-05-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or metastatic clear cell renal cell carcinoma (ccRCC)

Interventions

Arm A (Experimental Arm) Casdatifan and cabozantinib taken orally. Arm B (Comparator Arm) Placebo and cabozantinib taken orally.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Progression-free Survival (PFS)	—

Secondary

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

—

Countries

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

Contacts

Public ContactYuji Yamamoto

Taiho Pharmaceutical Co., Ltd.

yuji-yamamoto@taiho.co.jp+81-3-3294-4527

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026