Kidney Cancer Clinical Trial

A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma

Summary

This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, inoperable, locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Unresectable advanced or metastatic renal cell carcinoma with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic agents, including treatment in the adjuvant setting
Measurable disease, as defined by RECIST v1.1
Karnofsky performance score greater than or equal to (>/=) 70
Adequate hematologic and end-organ function as defined by protocol
Women of childbearing potential and male participants with partners of childbearing potential must agree to use highly effective methods of contraception as defined by protocol

Exclusion Criteria:

Disease-Specific Exclusions:

Radiotherapy for renal cell carcinoma within 14 days prior to Cycle 1, Day 1 with the exception of single-fraction radiotherapy given for the indication of pain control
Known active malignancies or metastasis of the brain or spinal cord or leptomeningeal disease, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
Uncontrolled hypercalcemia or symptomatic hypercalcemia
Malignancies other than renal cell carcinoma within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death, treated with expected curative outcome

General Medical Exclusions:

Life expectancy of less than (<) 12 weeks
Pregnant and lactating women
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
History of autoimmune disease
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
Participants with active or chronic hepatitis B, active hepatitis C, Human Immunodeficiency Virus (HIV) positive test, significant cardiovascular disease
Prior allogeneic stem cell or solid organ transplant

Exclusion Criteria Related to Medications:

Prior treatment with Cluster of Differentiation 137 (CD137) agonists, anti-Cytotoxic T-Lymphocyte Antigen-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Treatment with systemic immunostimulatory agents for any reason within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1

Bevacizumab- and Sunitinib-Specific Exclusions:

Inadequately controlled hypertension
Prior history of hypertensive crisis or hypertensive encephalopathy
New York Heart Association Class II or greater congestive heart failure
History of myocardial infarction or unstable angina, stroke or transient ischemic attack within 3 months prior to Cycle 1, Day 1

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

305

Study ID:

NCT01984242

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 44 Locations for this study

See Locations Near You

HonorHealth Research Institute - Bisgrove
Scottsdale Arizona, 85258, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
UCLA
Los Angeles California, 90024, United States
University of California
San Francisco California, 94158, United States
Univ Colorado Health Sci Ctr
Aurora Colorado, 80045, United States
Rocky Mountain Cancer Ctr - Denver (Williams)
Denver Colorado, 80218, United States
Yale Uni School of Medicine; Section of Medical Oncology
New Haven Connecticut, 06510, United States
Georgetown U; Lombardi Comp Can
Washington District of Columbia, 20016, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
Mayo Clinic-Jacksonville
Jacksonville Florida, 32224, United States
Florida Cancer Specialist, North Region
Saint Petersburg Florida, 33705, United States
The University of Chicago
Chicago Illinois, 60637, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Inst.
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute.
Detroit Michigan, 48201, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89128, United States
Memorial Sloan-Kettering
New York New York, , United States
Oncology Hematology Care Inc
Cincinnati Ohio, 45242, United States
Cleveland Clinic Foundation; Taussig Cancer Center
Cleveland Ohio, 44195, United States
Oncology Associates of Oregon, P.C
Eugene Oregon, 97401, United States
Northwest Cancer Specialists, P.C.
Tigard Oregon, 97223, United States
Tennessee Oncology PLLC - Nashville (20th Ave)
Nashville Tennessee, 37203, United States
Vanderbilt Medical Center
Nashville Tennessee, 37232, United States
Texas Oncology-Baylor Sammons Cancer Center
Dallas Texas, 75246, United States
Fakultni nemocnice Olomouc
Olomouc , 775 2, Czechia
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
Paris , 75908, France
CHU Bordeaux
Pessac , 33604, France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif , 94805, France
Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
Hannover , 30625, Germany
Klinikum rechts der Isar der TU München; Klinikapotheke
Muenchen , 81675, Germany
Klinikum d.Universität München Campus Großhadern
München , 81377, Germany
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano Lombardia, 20133, Italy
Medical Oncology, Arezzo
Arezzo Toscana, 52100, Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena Toscana, 53100, Italy
Centrum Med. Ostrobramska NZOZ Magodent
Warszawa , 04-12, Poland
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj Napoca , 40001, Romania
Medisprof SRL
Cluj-Napoca , 40005, Romania
Clinica Universitaria de Navarra
Pamplona Navarra, 31008, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department
Barcelona , 08036, Spain
Hosp de Madrid Norte Sanchinarro; Centro Integral; Onco Clara Campal
Madrid , 28050, Spain
Barts and the London NHS Trust.
London , EC1A , United Kingdom
Royal Marsden Hospital - London
London , SW3 6, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester , M2O 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

305

Study ID:

NCT01984242

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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