Renal cell carcinoma, Cancer
Conditions
Sponsors
CHUGAI PHARMACEUTICAL CO., LTD.
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age >/= 18 years -ECOG performance status of </= 1 -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Investigator-assessed DFS | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics pharmacogenomics RECIST | — |
Countries
Asia except Japan, Europe, Japan, Middle East, North America, Oceania, South America
Outcome results
None listed