Study MO39939 is an open-label, single-arm, multicenter trial in patients with unresectable, locally-advanced or metastatic, clear or non-clear cell renal cell carcinoma (RCC) who have not received prior systemic therapy (who are treatment naïve in either the \[neo\]adjuvant or advanced/metastatic setting for clear and non-clear cell RCC). The study consists of a Screening Period, a Treatment Period, an End of Treatment Visit occurring approximately 30 days after the last dose of study medication, and a Follow-Up Period of 4 years after last patient enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle. Administration of study drugs will continue until unacceptable toxicity; loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status; investigator or patient decision to withdraw from therapy; or death (whichever occurs first).
Bevacizumab will be administered by IV infusion at 15 mg/kg on Day 1 of each 21-day cycle. Administration of study drugs will continue until unacceptable toxicity; loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status; investigator or patient decision to withdraw from therapy; or death (whichever occurs first).
Percentage of Participants with Adverse Events
Time frame: Up to 6 years
Overall Survival (OS)
OS is defined as the time from enrolment in the study to death from any cause
Time frame: Up to 6 years
Progression-Free survival (PFS)
PFS is defined as the time from enrolment in the study to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be assessed by the investigator according to RECIST v1.1 and modified RECIST (iRECIST)
Time frame: Up to 6 years
Overall Response Rate (ORR)
ORR is defined as the proportion of patients with a best overall response of either complete response (CR) or partial response (PR). ORR will be assessed by the investigator according to RECIST v1.1 and iRECIST.
Time frame: Up to 6 years
Disease Control Rate (DCR)
DCR is defined as the sum of the CR, PR and stable disease (SD) rates. DCR will be assessed by the investigator according to RECIST v1.1 and iRECIST.
Time frame: Up to 6 years
Duration of Response (DoR)
DoR is defined as the time from first occurrence of a documented response to disease progression or death from any cause, whichever occurs first. DoR will be assessed by the investigator according to RECIST v1.1 and iRECIST.
Time frame: Up to 6 years
PD-L1 Expression in Tumor Samples From the Tumor Tissue
Measured retrospectively by immunohistochemistry (IHC).
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Time frame: At baseline
Change From Baseline in the Single Item (GP5) of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (FKSI-19), Version 2
Time frame: Before dosing on Day 1 of each cycle, at the End-of-Treatment visit, and at 3, 6, and 9 months after the End-of-Treatment visit. End-of-Treatement visit occurring approximately 30 days after last cycle treatment date. Each cycle is 21 days.
Change From Baseline in MD Anderson Symptom Inventory (MDASI) Core and MDASI-RCC Module
Time frame: Before dosing on Day 1 of each cycle, at the End-of-Treatment visit, and at 3, 6, and 9 months after the End-of-Treatment visit. End-of-Treatment visit occurring approximately 30 days after last cycle treatment date. Each cycle is 21 days.
Time to Deterioration of Daily Functioning
Time to deterioration of daily functioning is defined as the time from enrolment to first ≥ 2-point increase above baseline in MDASI interference score.
Time frame: Before dosing on Day 1 of each cycle, at the End-of-Treatment visit, and at 3, 6, and 9 months after the End-of-Treatment visit. End-of-Treatment visit occurring approximately 30 days after last cycle treatment date. Each cycle is 21 days.