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

Arcus Biosciences

Status and phase: Enrolling; Phase 3

Conditions: Metastatic Clear Cell Renal Cell Carcinoma; Advanced Clear Cell Renal Cell Carcinoma

Treatments: Drug: Placebo; Drug: Casdatifan; Drug: Cabozantinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07011719

2024-515023-11-00 (EU Trial (CTIS) Number)

PEAK-1

Details and patient eligibility

About

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 in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.

Enrollment: 720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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, ≤ 72 hours 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.
• 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, as defined by a sustained blood pressure > 140/90 mm Hg on more than three antihypertensives
• History of leptomeningeal disease or spinal cord compression.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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720 participants in 2 patient groups, including a placebo group

Arm A (Experimental Arm)

Experimental group

Description:

Casdatifan and cabozantinib taken orally

Treatment:

Drug: Cabozantinib

Drug: Casdatifan

Arm B (Comparator Arm)

Placebo Comparator group

Description:

Placebo and cabozantinib taken orally

Treatment:

Drug: Cabozantinib

Drug: Placebo