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.
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 = 1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable in the opinion of the investigator. Grade 2 alopecia is allowed for study participation
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)
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There are 142 Locations for this study
Tucson Arizona, 85724, United States
Duarte California, 91010, United States
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Aurora Colorado, 80045, United States
Littleton Colorado, 80120, United States
Pensacola Florida, 32503, United States
Tampa Florida, 33612, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Saint Paul Minnesota, 55102, United States
Las Vegas Nevada, 89169, United States
Middletown New Jersey, 07748, United States
Montvale New Jersey, 07645, United States
Albany New York, 12208, United States
Bronx New York, 10461, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10029, United States
New York New York, 10065, United States
Syracuse New York, 13210, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44106, United States
Philadelphia Pennsylvania, 19111, United States
Austin Texas, 78731, United States
Salt Lake City Utah, 84108, United States
Gainesville Virginia, 20155, United States
Buenos Aires , C1125, Argentina
Buenos Aires , C1426, Argentina
Ciudad Autonoma Bs As , C1280, Argentina
Ciudad Autonoma Buenos Aires , C1019, Argentina
Macquarie Park New South Wales, 2109, Australia
Orange New South Wales, 2800, Australia
South Brisbane Queensland, 4101, Australia
Bendigo Victoria, 3550, Australia
Hamilton Ontario, L8N 4, Canada
Toronto Ontario, M5G 1, Canada
Herlev , 2730, Denmark
Besançon Cedex , 25030, France
Bordeaux , 33075, France
Caen , 14076, France
Clermont Ferrand , 63011, France
Lille , 59000, France
Lyon , 69373, France
Nice , 06189, France
Nimes , 30029, France
Paris , 75908, France
Strasbourg , 67200, France
Villejuif , 94800, France
Chemnitz , 09130, Germany
Frankfurt , 60590, Germany
Freiburg , 79106, Germany
Halle (Saale) , 06120, Germany
Hamburg , 20246, Germany
Hannover , 30625, Germany
Muenster , 48149, Germany
München , 81675, Germany
Tübingen , 72076, Germany
Ulm , 89081, Germany
Athens , 115 2, Greece
Athens , 151 2, Greece
Chaidari , 124 6, Greece
Larissa , 411 1, Greece
Thessaloniki , 570 0, Greece
Napoli Campania, 80131, Italy
Bologna Emilia-Romagna, 40138, Italy
Meldola Emilia-Romagna, 47014, Italy
Roma Lazio, 00168, Italy
Brescia Lombardia, 25123, Italy
Milano Lombardia, 20133, Italy
Pavia Lombardia, 27100, Italy
Rozzano Lombardia, 20089, Italy
Macerata Marche, 62100, Italy
Candiolo (TO) Piemonte, 10060, Italy
Bari Puglia, 70124, Italy
Terni Umbria, 05100, Italy
Verona Veneto, 37134, Italy
Hokkaido , 060-8, Japan
Ibaraki , 305-8, Japan
Kanagawa , 236-0, Japan
Okayama , 700-8, Japan
Osaka , 545-8, Japan
Tokushima , 770-8, Japan
Tokyo , 160-8, Japan
Tokyo , 162-8, Japan
Daejeon , 35015, Korea, Republic of
Gyeonggi-do , 13496, Korea, Republic of
Gyeongsangnam-do , 50612, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Seongnam-si , 463-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03181, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
?ód? , 90-33, Poland
Brzozów , 36-20, Poland
Bydgoszcz , 85-79, Poland
Bytom , 41-90, Poland
Otwock , 05-40, Poland
Pozna? , 60-56, Poland
Warszawa , 04-07, Poland
Warszawa , 04-14, Poland
Wroc?aw , 53-41, Poland
Yaroslavl Jaroslavl, 15005, Russian Federation
Kuzmolovo Leningrad, 18866, Russian Federation
Innovatsionnogo Tsentra Skolkovo Moskovskaja Oblast, 12120, Russian Federation
Moscow Moskovskaja Oblast, 11547, Russian Federation
Moscow Moskovskaja Oblast, 14342, Russian Federation
Moskva Moskovskaja Oblast, 11112, Russian Federation
Moskva Moskovskaja Oblast, 11799, Russian Federation
Sait-Petersburg Sankt Petersburg Sankt Petersburg, 19600, Russian Federation
St. Petersburg Sankt Petersburg, 19527, Russian Federation
Novosibirsk , 63009, Russian Federation
Oviedo Asturias, 33011, Spain
Sabadell Barcelona, 8208, Spain
Santander Cantabria, 39008, Spain
Córdoba Cordoba, 14004, Spain
Palma De Mallorca Islas Baleares, 07014, Spain
Vigo Pontevedra, 36213, Spain
Barcelona , 08035, Spain
Barcelona , 08041, Spain
Burgos , 09006, Spain
Caceres , 10003, Spain
Lugo , 27003, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Murcia , 30120, Spain
Navarra , 31008, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Blackburn , BB2 3, United Kingdom
Leicester , LE1 5, United Kingdom
London , EC1A , United Kingdom
London , SW3 6, United Kingdom
Manchester , M2O 4, United Kingdom
Sutton , SM2 5, United Kingdom
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