A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Renal Cell Carcinoma

In brief

This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

Key facts

Study ID

NCT03024996

Run by

Hoffmann-La Roche

People needed

778

Starts

2017-01-03

Expected to finish

2022-12-08

Last updated by the study team

2023-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG performance status of less than or equal to (</=) 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 and classified as being at high risk of RCC recurrence
• Radical or partial nephrectomy with lymphadenectomy in select participants
• Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization. Confirmation of disease-free status will be assessed by an independent central radiologic review of imaging data.
• Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to randomization. Applicable only to metastasectomy participants
• Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery

You may not qualify if…

• 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
• Malignancies other than RCC within 5 years prior to Cycle 1, Day 1
• History of autoimmune disease
• Participants 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
• Positive test for HIV
• Participants with active hepatitis B or hepatitis C
• Active tuberculosis
• Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
• Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
• Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
• Prior treatment with cluster of differentiation (CD)137 agonists, anti-cytotoxic T-lymphocyte-associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibody or pathway-targeting agents
• Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization
• Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to randomization or anticipated need for systemic immunosuppressive medications during the study

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• City of Hope, Antelope Valley — Lancaster, California, United States
• UCLA Urology; Urology — Los Angeles, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• City of Hope-South Pasadena — South Pasadena, California, United States
• City of Hope; Upland — Upland, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Florida Cancer Specialists-Broadway, Fort Myers — Fort Myers, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Univ of Miami, School of Med; Hem/Onc — Miami, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Emory Uni - Winship Cancer Center; Hematology/Oncology — Atlanta, Georgia, United States
• The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology — Chicago, Illinois, United States
• Loyola University Medical Center, Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Tulane Uni Health Sciences Center — New Orleans, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Chesapeake Urology Research Associates — Towson, Maryland, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Garden State Urology — Whippany, New Jersey, United States
• New York Oncology Hematology at Albany Medical Center — Albany, New York, United States
• Bellevue Hospital — New York, New York, United States
• Laura and ISAAC Perlmutter Cancer Center at NYU Langone. — New York, New York, United States
• Mayo Clinic- Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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