Recruiting NCT07011719

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

Phase III Interventional Metastatic Clear Cell Renal Cell Carcinoma Advanced Clear Cell Renal Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Casdatifan, Cabozantinib, Placebo.
Who it may be relevant to: Registry conditions: Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Canada, Czechia +11
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

Drug Casdatifan
Administered as specified in the treatment arm
Drug Cabozantinib
Administered as specified in the treatment arm
Drug Placebo
Administered as specified in the treatment arm

Primary outcome measures

Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 [Time frame: up to approximately 33 months]

Secondary outcome measures (6)

Overall Survival (OS) [Time frame: up to approximately 64 months]
Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 [Time frame: up to approximately 33 months]
Duration of Response (DOR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 [Time frame: up to approximately 33 months]
Disease Control Rate (DCR) by Blinded Independent Central Review (BICR) [Time frame: up to approximately 33 months]
The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs) [Time frame: up to approximately 33 months]
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. [Time frame: up to approximately 33 months]

Eligibility criteria

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, ≤ 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 44 centers

Research Site — Gilbert
Research Site — Goodyear
Research Site — Phoenix
Research Site — Duarte
Research Site — Irvine
Research Site — La Jolla
Research Site — Los Angeles
Research Site — Sacramento
… and 36 more centers

France · 15 centers

Research Site — Angers
Research Site — Brest
Research Site — Caen
Research Site — Clermont-Ferrand
Research Site — Lille
Research Site — Marseille
Research Site — Montpellier
Research Site — Paris
… and 7 more centers

Germany · 13 centers