A PHASE III PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB(ANTI-PD-L1 ANTIBODY)AS ADJUVANT THERAPY IN PATIENTS WITH RENAL CELL CARCINOMA AT HIGH RISK OF DEVELOPING METASTASIS FOLLOWING NEPHRECTOMY
- Conditions
- Renal cell carcinoma, Cancer
- Registration Number
- JPRN-jRCT2080223426
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
The study did not meet the primary endpoint of investigator assessed disease free survival (INV-DFS) at the primary analysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 778
Age >/= 18 years
-ECOG performance status of -Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology that has not been previously treated in the adjuvant or neoadjuvant setting
-Absence of residual disease and absence of metastasis
-Absence of brain metastasis
-Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery
-Adequate hematologic and end-organ function
-For women of childbearing potential who are agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period for at least 5 months after the last dose of study drug
-Bilateral synchronous tumors with inheritable forms of RCC including von Hippel Lindau
-Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
-Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days or five half-lives of the investigational agent, whichever is longer, prior to enrollment
-CNS metastases or leptomeningeal disease
-Malignancies other than RCC within 5 years prior to Cycle 1, Day 1
-Life expectancy of < 24 weeks
-Pregnancy or lactation, or intending to become pregnant during the study
-History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
-Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
-History of autoimmune disease
-Patients with prior allogeneic stem cell or solid organ transplantation
-History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
-Significant cardiovascular disease
-Positive test for HIV and/or patients with active hepatitis B or hepatitis C or active tuberculosis
-Severe infections within 4 weeks prior to initiation of study treatment
-Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
-Prior treatment with CD137 agonists, anti-CTLA-4, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway targeting agents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method