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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
720
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
City of Hope - Phoenix Cancer Center
Goodyear, Arizona, United States
RECRUITINGMayo Clinic - Phoenix
Phoenix, Arizona, United States
RECRUITINGCity Of Hope National Medical Center
Duarte, California, United States
RECRUITINGUniversity of California San Diego Moores Cancer Center
La Jolla, California, United States
Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
Time frame: up to approximately 33 months
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
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UCLA Hematology Oncology - 100 Med Plaza
Los Angeles, California, United States
RECRUITINGUniversity of California San Diego Moores Cancer Center
San Diego, California, United States
RECRUITINGYale University
New Haven, Connecticut, United States
RECRUITINGMayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGPiedmont Cancer Institute OneOncology
Atlanta, Georgia, United States
RECRUITINGEmory University - Atlanta
Atlanta, Georgia, United States
RECRUITING...and 34 more locations