This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that the higher dose of belzutifan is superior to the standard dose in terms of objective response rate (ORR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Oral administration
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
ORR was defined as the percentage of participants who had a complete response (CR: Disappearance of all target lesions) or a partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by blinded independent central review based on RECIST 1.1 was presented.
Time frame: Up to approximately 27 months
Progression-Free Survival (PFS) According to RECIST 1.1 as Assessed by BICR
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by blinded independent central review was presented.
Time frame: Up to approximately 27 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
For participants who demonstrated a confirmed complete response (CR: Disappearance of all target lesions) or confirmed partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR as assessed by blinded independent central review was presented.
Time frame: Up to approximately 27 months
Clinical Benefit Rate (CBR) Per RECIST 1.1 as Assessed by BICR
CBR is defined as the percentage of participants who have a complete response (CR: Disappearance of all target lesions) or a partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) or stable disease (SD: Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.) ≥6 months per RECIST 1.1. The percentage of participants with CBR will be presented.
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Georgetown University Medical Center ( Site 0002)
Washington D.C., District of Columbia, United States
Univ of Miami- Sylvester Comprehensive Cancer Center ( Site 0023)
Miami, Florida, United States
Norton Cancer Institute - St. Matthews ( Site 0025)
Louisville, Kentucky, United States
Weinberg Cancer Institute at Franklin Square ( Site 0007)
Baltimore, Maryland, United States
Cancer Partners of Nebraska ( Site 0003)
Lincoln, Nebraska, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0012)
Omaha, Nebraska, United States
New York Oncology Hematology P.C ( Site 0028)
Albany, New York, United States
Roswell Park Cancer Institute ( Site 0038)
Buffalo, New York, United States
Fox Chase Cancer Center ( Site 0026)
Philadelphia, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic ( Site 0031)
Sioux Falls, South Dakota, United States
...and 38 more locations
Time frame: Up to approximately 27 months
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 27 months
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one or more AEs was presented.
Time frame: Up to approximately 27 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE was presented.
Time frame: Up to approximately 26 months
Maximum Plasma Concentration (Cmax) of Belzutifan
Blood samples were obtained at designated time points for the determination of the Cmax of belzutifan.
Time frame: Weeks 1 and 3 on Day 1: predose and 1, 2, and 4 hours. Week 5 on Day 1: predose only
Trough Plasma Concentration (Ctrough) of Belzutifan
Blood samples were obtained at designated time points for the determination of the Ctrough of belzutifan.
Time frame: Weeks 1 and 3 on Day 1: predose and 1, 2, and 4 hours. Week 5 on Day 1: predose only