A Phase III Study of Atezolizumab in Patients with 2L/3L Renal Cell Carcinoma
- Conditions
- Carcinoma, Renal Cell
- Registration Number
- JPRN-jRCT2080225357
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 500
Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary, chromophobe, and unclassified only) RCC. RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation.
-Radiographic disease progression during or following treatment with ICI for locally advanced or metastatic RCC either in first- or second-line treatment. Patients who experienced radiographic tumor progression during or within 6 months after the last dose of adjuvant ICI are also eligible. ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, durvalumab, or nivolumab. Only patients for whom the immediate preceding line of therapy was an ICI are allowed.
-Measurable disease per RECIST v1.1
-Evaluable IMDC risk score
-Archival tumor specimen, and pretreatment tumor tissue from fresh biopsy at screening, if clinically feasible
-KPS score of >=70
-Recovery to baseline or Grade=< 1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable in the opinion of the investigator. Grade 2 alopecia is allowed for study participation
-Adequate hematologic and end-organ function
-Negative HIV test at screening
-Negative hepatitis B testing at screening
-Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
-For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
-For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
-Treatment with anti-cancer therapy within 14 days prior to initiation of study treatment
-Patients received cabozantinib at any time prior to screening
-Patients who received more than one ICI treatment in the locally advanced or metastatic setting
-Patients who received more than two prior lines of therapy in the locally advanced or metastatic setting
-Patients who have received a mammalian target of rapamycin (mTOR) inhibitor in any setting
-Symptomatic, untreated, or actively progressing CNS metastases
-History of leptomeningeal disease
-Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
-Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
-History of malignancy other than renal carcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
-Radiotherapy for RCC within 14 days prior to Day 1 of Cycle 1
-Active tuberculosis
-Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
-Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after final dose of atezolizumab and 4 months after final dose of cabozantinib
-Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
-Pharmacologically uncompensated, symptomatic hypothyroidism
-Uncontrolled hypertension defined as sustained blood pressure >150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment
-Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, unstable arrhythmia, or unstable angina) within 3 months prior to initiation of study treatment
-Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1
-History of congenital QT syndrome
-History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
-Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g. clopidogrel)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method