Kidney Cancer Clinical Trial

A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment

Summary

This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 to prior ICI therapy for RCC. 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. Both archival and fresh samples are preferred.
KPS score of >=70
Recovery to baseline or Grade 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

Exclusion Criteria:

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, or any active infection that, in the opinion of the investigator, could impact patient safety
Pharmacologically uncompensated, symptomatic hypothyroidism
Uncontrolled hypertension defined as sustained blood pressure >150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment (all countries except France); sustained BP > 140 mmHg systolic or > 90 mmHg diastolic despite optimal antihypertensive treatment (France only)
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 is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

522

Study ID:

NCT04338269

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 142 Locations for this study

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University of Arizona
Tucson Arizona, 85724, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
UC San Diego Health System
La Jolla California, 92093, United States
UCLA
Los Angeles California, 90095, United States
University of Colorado
Aurora Colorado, 80045, United States
Rocky Mountain Cancer Center - Denver
Littleton Colorado, 80120, United States
Woodlands Medical Specialists, P.A.
Pensacola Florida, 32503, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Skip Viragh Outpatient Cancer Building
Baltimore Maryland, 21287, United States
MGH
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Med Ctr
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Minnesota Oncology Hematology
Saint Paul Minnesota, 55102, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas Nevada, 89169, United States
Memorial Sloan Kettering - Monmouth
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale New Jersey, 07645, United States
New York Oncology Hematology,P.C.-Albany
Albany New York, 12208, United States
Montefiore Medical Center
Bronx New York, 10461, United States
Memorial Sloan Kettering Cancer Center - Commack
Commack New York, 11725, United States
MSKCC @ West Harrison
Harrison New York, 10604, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Cleveland Clinic
Cleveland Ohio, 44106, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Texas Onc-Central Austin CA Ct
Austin Texas, 78731, United States
University Of Utah
Salt Lake City Utah, 84108, United States
Virginia Cancer Specialists - Gainsville
Gainesville Virginia, 20155, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires , C1125, Argentina
Inst. Alexander Fleming; Oncologia
Buenos Aires , C1426, Argentina
Hospital Britanico
Ciudad Autonoma Bs As , C1280, Argentina
Centro Medico Austral OMI
Ciudad Autonoma Buenos Aires , C1019, Argentina
Macquarie University Hospital
Macquarie Park New South Wales, 2109, Australia
Orange Hospital
Orange New South Wales, 2800, Australia
Icon Cancer Foundation
South Brisbane Queensland, 4101, Australia
Bendigo Cancer Centre
Bendigo Victoria, 3550, Australia
St. Joseph's Healthcare Hamilton
Hamilton Ontario, L8N 4, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
Herlev Hospital; Afdeling for Kræftbehandling
Herlev , 2730, Denmark
CHU Besançon - Hôpital Jean Minjoz
Besançon Cedex , 25030, France
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
Bordeaux , 33075, France
Centre Francois Baclesse; Oncologie
Caen , 14076, France
Centre Jean Perrin; Oncologie
Clermont Ferrand , 63011, France
Centre Oscar Lambret; Chir Cancerologie General
Lille , 59000, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon , 69373, France
Centre Antoine Lacassagne
Nice , 06189, France
Institut de cancerologie du Gard
Nimes , 30029, France
Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
Paris , 75908, France
ICANS
Strasbourg , 67200, France
Institut Gustave Roussy; Oncologie Medicale
Villejuif , 94800, France
Zeisigwaldkliniken Bethanien
Chemnitz , 09130, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet; Urologie und Kinderurologie
Frankfurt , 60590, Germany
Universitaetsklinikum Freiburg; Urology
Freiburg , 79106, Germany
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
Halle (Saale) , 06120, Germany
Uniklinik-Eppendorf; Klinik U Poliklinik F Urologie
Hamburg , 20246, Germany
Med. Hochschule Hannover, Hämatologie, Hämostaseologie, Onkologie u. Stammzelltransplantation
Hannover , 30625, Germany
Universitaetsklinikum Muenster; Urology
Muenster , 48149, Germany
Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
München , 81675, Germany
Universitätsklinikum Tübingen; Klinik für Urologie
Tübingen , 72076, Germany
Universitätsklinikum Ulm; Klinik für Urologie
Ulm , 89081, Germany
Alexandras General Hospital of Athens; Oncology Department
Athens , 115 2, Greece
Athens Medical Center; Dept. of Oncology
Athens , 151 2, Greece
Attikon University General Hospital
Chaidari , 124 6, Greece
University Hospital of Larissa;Department of Medical Oncology
Larissa , 411 1, Greece
Diavalkaniko Hospital
Thessaloniki , 570 0, Greece
Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica
Napoli Campania, 80131, Italy
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna Emilia-Romagna, 40138, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola Emilia-Romagna, 47014, Italy
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica
Roma Lazio, 00168, Italy
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
Brescia Lombardia, 25123, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano Lombardia, 20133, Italy
Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica
Pavia Lombardia, 27100, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano Lombardia, 20089, Italy
Ospedale Di Macerata; Oncologia
Macerata Marche, 62100, Italy
Fondazione del Piemonte per l?Oncologia (IRCCS); Day Hospital Oncologico Multidisciplinare
Candiolo (TO) Piemonte, 10060, Italy
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari; U.O. Oncologia Medica Universitaria
Bari Puglia, 70124, Italy
Azienda Ospedaliera S. Maria - Terni; Oncologia
Terni Umbria, 05100, Italy
A.O.U di Verona Policlinico G.B. Rossi; Centro Ricerche Cliniche
Verona Veneto, 37134, Italy
Hokkaido University Hospital
Hokkaido , 060-8, Japan
University of Tsukuba Hospital
Ibaraki , 305-8, Japan
Yokohama City University Hospital
Kanagawa , 236-0, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Osaka Metropolitan University Hospital
Osaka , 545-8, Japan
Tokushima University Hospital
Tokushima , 770-8, Japan
Keio University Hospital
Tokyo , 160-8, Japan
Tokyo Women's Medical University Hospital
Tokyo , 162-8, Japan
Chungnam National University Hospital
Daejeon , 35015, Korea, Republic of
CHA Bundang Medical Center
Gyeonggi-do , 13496, Korea, Republic of
Pusan National University Yangsan Hospital
Gyeongsangnam-do , 50612, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 463-7, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Kangbuk Samsung Medical Center
Seoul , 03181, Korea, Republic of
Severance Hospital
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
?ód? , 90-33, Poland
Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
Brzozów , 36-20, Poland
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii
Bydgoszcz , 85-79, Poland
SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej
Bytom , 41-90, Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock , 05-40, Poland
Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii
Pozna? , 60-56, Poland
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
Warszawa , 04-07, Poland
Wojskowy Instytut Medyczny; Klinika Onkologii
Warszawa , 04-14, Poland
Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii
Wroc?aw , 53-41, Poland
Regional Clinical Oncology Hospital
Yaroslavl Jaroslavl, 15005, Russian Federation
St-Petersburg Regional Oncology Dispensary; Oncology
Kuzmolovo Leningrad, 18866, Russian Federation
Branch of the company "Hadassah Medical LTD"
Innovatsionnogo Tsentra Skolkovo Moskovskaja Oblast, 12120, Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow Moskovskaja Oblast, 11547, Russian Federation
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy
Moscow Moskovskaja Oblast, 14342, Russian Federation
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
Moskva Moskovskaja Oblast, 11112, Russian Federation
National Medical Research Center for Surgery named after A.V. Vishnevsky
Moskva Moskovskaja Oblast, 11799, Russian Federation
AV Medical Ltd.
Sait-Petersburg Sankt Petersburg Sankt Petersburg, 19600, Russian Federation
Private Healthcare Institution Clinical Hospital RZhD Medicine
St. Petersburg Sankt Petersburg, 19527, Russian Federation
Medical Center Avicenna; Urology
Novosibirsk , 63009, Russian Federation
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo Asturias, 33011, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell Barcelona, 8208, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander Cantabria, 39008, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba Cordoba, 14004, Spain
Hospital Universitario Son Espases; Servicio de Oncologia
Palma De Mallorca Islas Baleares, 07014, Spain
Hospital Alvaro Cunqueiro; Servicio de Oncologia
Vigo Pontevedra, 36213, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona , 08035, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona , 08041, Spain
Hospital Universitario de Burgos; Oncología
Burgos , 09006, Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia
Caceres , 10003, Spain
Hospital Lucus Augusti; Servicio de Oncologia
Lugo , 27003, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga , 29010, Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia , 30120, Spain
Hospital de Navarra; Servicio de Oncologia
Navarra , 31008, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Hospital Universitario la Fe; Servicio de Oncologia
Valencia , 46026, Spain
Royal Blackburn Hospital
Blackburn , BB2 3, United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester , LE1 5, United Kingdom
Barts & London School of Med; Medical Oncology
London , EC1A , United Kingdom
Royal Marsden Hospital; Dept of Med-Onc
London , SW3 6, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester , M2O 4, United Kingdom
Royal Marsden Hospital (Sutton)
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

522

Study ID:

NCT04338269

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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