Prostate Cancer Clinical Trial
Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
Summary
This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.
Full Description
The primary objective of this study is to evaluate the efficacy of cabozantinib (XL184) in combination with atezolizumab versus a second NHT (abiraterone or enzalutamide) in subjects with mCRPC who have previously been treated with one, and only one, NHT (e.g. abiraterone, apalutamide, darolutamide, or enzalutamide) to treat metastatic castration-sensitive prostate cancer (mCSPC), non-metastatic CRPC (M0 CRPC), or mCRPC, and who have measurable extrapelvic disease. The multiple primary efficacy endpoints comparing the experimental arm and control arm are Duration of Progression Free Survival (PFS) per RECIST 1.1 by Blinded Independent Radiology Committee (BIRC) and Duration of Overall Survival (OS). The secondary efficacy endpoint is Objective Response Rate (ORR) per RECIST 1.1 per BIRC.
Eligibility Criteria
Inclusion Criteria:
Men with histologically or cytologically confirmed adenocarcinoma of the prostate
Prior treatment with one, and only one, NHT (eg, abiraterone, apalutamide, darolutamide, or enzalutamide) for castration-sensitive locally advanced (T3 or T4) or mCSPC, M0 CRPC, or mCRPC
Surgical or medical castration, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening
Measurable (extrapelvic soft tissue) metastatic disease per Investigator assessment defined by at least one of the following: measurable visceral disease (eg, adrenal, kidney, liver, lung, pancreas, spleen) per RECIST 1.1; OR measurable extrapelvic adenopathy (ie, adenopathy above the aortic bifurcation)
Progressive disease at study entry as defined by specific criteria for prostate specific antigen (PSA) progression OR soft tissue disease progression in the opinion of the Investigator (Note: subjects with bone disease progression alone are not eligible)
Age ≥ 18 years old or meeting country definition of adult, whichever is older, on the day of consent
ECOG performance status of 0 or 1
Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator
Adequate organ and marrow function based upon specific laboratory assessments obtained within 21 days prior to randomization
Understanding and ability to comply with protocol requirements
Exclusion Criteria:
Any prior nonhormonal therapy initiated for the treatment of mCRPC
Receipt of abiraterone within 1 week; cyproterone within 10 days; or flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen-receptor inhibitors within 2 weeks before randomization
Radiation therapy within 4 weeks (2 weeks for bone metastases) prior to randomization (subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible)
Known brain metastases or cranial epidural disease unless adequately treated and clinically stable at least 4 weeks prior to randomization
Symptomatic or impending spinal cord compression or cauda equina syndrome
Concomitant anticoagulation with oral anticoagulants (some specific exceptions apply)
Administration of a live, attenuated vaccine within 30 days prior to randomization
Systematic treatment with, or any condition requiring, either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization
Uncontrolled, significant intercurrent or recent illness
Major surgery within 4 weeks prior to randomization
Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per ECG within 21 days before randomization
Inability or unwillingness to swallow pills or receive IV administration
Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies
Any other active malignancy at time of randomization or diagnosis of another malignancy within 2 years prior to randomization that requires active treatment (some exceptions apply such as locally curable cancers that have apparently been cured).
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There are 265 Locations for this study
Tucson Arizona, 85741, United States
Duarte California, 91010, United States
Fullerton California, 92835, United States
La Jolla California, 92093, United States
San Diego California, 92161, United States
Santa Monica California, 90404, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
Denver Colorado, 80211, United States
Miami Florida, 33125, United States
Westwood Kansas, 66205, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21204, United States
Rochester Minnesota, 55905, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89169, United States
East Brunswick New Jersey, 08816, United States
Bronx New York, 10461, United States
Cleveland Ohio, 44195, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37209, United States
Houston Texas, 77027, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Temple Texas, 76504, United States
Salt Lake City Utah, 84112, United States
Roanoke Virginia, 24014, United States
Ciudad Autonoma de Buenos Aire Buenos Aires, C1280, Argentina
Mar Del Plata Buenos Aires, B7600, Argentina
Pergamino Buenos Aires, B2700, Argentina
Córdoba Cordoba, X5004, Argentina
Viedma Rio Negro, R8500, Argentina
Rosario Santa Fe, S2000, Argentina
Rosario Santa Fe, S2000, Argentina
Buenos Aires , C1426, Argentina
Caba , C1120, Argentina
Ciudad Autonoma de Buenos Aire , C1012, Argentina
La Rioja , F5300, Argentina
San Juan , 5400, Argentina
San Salvador De Jujuy , Y4600, Argentina
Garran Australian Capital Territory, 2605, Australia
Port Macquarie New South Wales, 2444, Australia
Saint Leonards New South Wales, 2065, Australia
Sydney New South Wales, 2109, Australia
Wollongong New South Wales, 2500, Australia
Chermside Queensland, 4032, Australia
Launceston Tasmania, 7250, Australia
Ballarat Victoria, 3350, Australia
Frankston Victoria, 3199, Australia
Geelong Victoria, 3220, Australia
Melbourne Victoria, 3000, Australia
Saint Albans Victoria, 3021, Australia
Adelaide , 5000, Australia
Box Hill , 3128, Australia
Linz Oberösterreich, 4020, Austria
Linz Oberösterreich, 4020, Austria
Wien , 1080, Austria
Bonheiden Antwerpen, 2820, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Brussels , 1000, Belgium
Roeselare , 8800, Belgium
Curitiba Parana, 80520, Brazil
Curitiba Paraná, 80510, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Rio De Janeiro RJ, 22793, Brazil
Blumenau Santa Catarina, 89010, Brazil
Campinas Sao Paulo, 13083, Brazil
Sao Paulo SP, 04538, Brazil
Ribeirão Preto São Paulo, 14048, Brazil
São José Do Rio Preto São Paulo, 15090, Brazil
Barretos , 14784, Brazil
Fortaleza , 60336, Brazil
Porto Alegre , 90110, Brazil
Ribeirão Preto , 14015, Brazil
Santa Cruz Do Sul , 96810, Brazil
Edmonton Alberta, T6G 1, Canada
Kelowna British Columbia, V1Y 5, Canada
Moncton New Brunswick, E1C 6, Canada
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 5, Canada
Oakville Ontario, L6H 3, Canada
Granby Quebec, J2GIT, Canada
Montréal Quebec, H2X 3, Canada
Viña del Mar Región De ValparaÃso, 25205, Chile
Santiago de Chile Región Metropolitana De Santiago, 75009, Chile
Santiago Región Metropolitana, 75007, Chile
Providencia , 75007, Chile
Recoleta , 84203, Chile
Santiago , 75006, Chile
Temuco , 48104, Chile
ValparaÃso , 25403, Chile
Praha 2 Praha, 120 0, Czechia
Brno , 656 9, Czechia
Olomouc , 779 0, Czechia
Praha 2 , 128 0, Czechia
Praha 8 , 180 8, Czechia
Praha , 140 5, Czechia
Brest , 29229, France
Clermont-Ferrand , 63011, France
Dijon cedex , 21079, France
Hyères , 83400, France
La Roche-sur-Yon Cedex 9 , 85925, France
Nîmes , 30029, France
Paris , 75015, France
Quimper , 29107, France
Reims , 51100, France
Saint-Grégoire , 35760, France
Strasbourg , 67000, France
Strasbourg , 67200, France
Toulouse , 31059, France
Toulouse , 31076, France
Vandoeuvre les nancy , 54511, France
Tbilisi , 0112, Georgia
Tbilisi , 0141, Georgia
Tbilisi , 0144, Georgia
Tbilisi , 0159, Georgia
Tbilisi , 0167, Georgia
Tbilisi , 0186, Georgia
Nürtingen Baden-Wuerttemberg, 72622, Germany
Gutersloh Nordrhein-Westfalen, 33332, Germany
Duisburg North Rhine-Westphalia, 47179, Germany
Münster North Rhine-Westphalia, 48149, Germany
Lübeck Schleswig-Holstein, 23538, Germany
Berlin , 10117, Germany
Hamburg , 20246, Germany
Hannover , 30625, Germany
Tübingen , 72076, Germany
Athens Attica, 11526, Greece
Cholargós Attica, 15562, Greece
Maroussi Attica, 15123, Greece
Maroúsi Attica, 15125, Greece
Nea Kifisia Attica, 14564, Greece
Néo Fáliro Attica, 18547, Greece
Heraklion Crete, 71110, Greece
ThessalonÃki Macedonia, 54007, Greece
Larissa Thessaly, 41110, Greece
Budapest , 1062, Hungary
Budapest , 1082, Hungary
Budapest , 1122, Hungary
Budapest , 1145, Hungary
Debrecen , 4032, Hungary
Gyula , 5700, Hungary
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Petah tikva , 49414, Israel
Ramat Gan , 52656, Israel
Safed , 13110, Israel
Tel Aviv , 64239, Israel
Meldola FC, 47014, Italy
Rozzano Milano, 20089, Italy
Sondrio SO, 23100, Italy
Trento Trentino, 38122, Italy
Ancona , 60126, Italy
Firenze , 50134, Italy
Milano , 20133, Italy
Milan , 20132, Italy
Parma , 43126, Italy
Pavia , 27100, Italy
Perugia , 06132, Italy
Pisa , 56126, Italy
Roma , 00144, Italy
Roma , 00168, Italy
Terni , 05100, Italy
Toyota-shi Aichi, 471-8, Japan
Akita-Shi Akita, 010-8, Japan
Hirosaki Aomori, 036-8, Japan
Kashiwa-shi Chiba, 277-8, Japan
Sakura-shi Chiba, 285-8, Japan
Sapporo Hokkaido, 060-8, Japan
Sapporo Hokkaido, 060-8, Japan
Kobe Hyogo, 650-0, Japan
Kobe Hyogo, 650-0, Japan
Kita-gun Kagawa, 761-0, Japan
Sagamihara Kanagawa, 252-0, Japan
Yokohama-shi Kanagawa, 232-0, Japan
Natori-shi Miyagi, 981-1, Japan
Chuo-Ku Osaka-shi, 541-8, Japan
Hidaka Saitama, 350-1, Japan
Shizuoka City Shizuoka, 420-8, Japan
Shinjuku-Ku Tokyo, 160-8, Japan
Ube Yamaguchi, 755-8, Japan
Chiba , 260-8, Japan
Fukuoka , 815-8, Japan
Nagano , 381-8, Japan
Tokyo , 135-8, Japan
Wakayama , 641-8, Japan
ÅŒsaka-sayama , 589-8, Japan
Junggu Daejeon, 35015, Korea, Republic of
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seongnam-si Gyeonggi-Do, 13620, Korea, Republic of
Hwasun Jeollanam-do, 58128, Korea, Republic of
Busan , 47392, Korea, Republic of
Busan , 49241, Korea, Republic of
Daegu , 41404, Korea, Republic of
Daegu , 42601, Korea, Republic of
Gwangju , 61469, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06273, Korea, Republic of
Seoul , 06351, Korea, Republic of
Tuxtla Gutiérrez Chiapas, 29038, Mexico
Mexico City Distrito Federal, 06760, Mexico
Leon Guanajuato, 37178, Mexico
Guadalajara Jalisco, 44500, Mexico
Guadalajara Jalisco, 44600, Mexico
Zapopan Jalisco, 45040, Mexico
Monterrey Nuevo Leon, 64710, Mexico
Querétaro Queretaro, 76070, Mexico
Querétaro Queretaro, 76230, Mexico
San Luis Potosà San Luis Potosi, 78200, Mexico
San Luis Potosà San Luis Potosi, 78209, Mexico
Culiacán Sinaloa, C.P. , Mexico
Mexico City , 01120, Mexico
Puebla , 72530, Mexico
Otwock Mazowieckie, 05-40, Poland
Bydgoszcz , 85-79, Poland
Poznań , 60-56, Poland
Åódź , 93-51, Poland
Braga , 4710-, Portugal
Guimarães , 4835-, Portugal
Lisboa , 1400-, Portugal
Lisboa , 1500-, Portugal
Loures , 2674-, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Vila Real , 5000-, Portugal
Moscow , 11547, Russian Federation
Saint Petersburg , 19702, Russian Federation
Saint Petersburg , 19775, Russian Federation
Singapore , 16961, Singapore
Singapore , 25849, Singapore
Singapore , 32956, Singapore
Elche Alicante, 03203, Spain
Oviedo Asturias, 33011, Spain
Manresa Barcelona, 08243, Spain
Palma De Mallorca Islas Baleares, 07120, Spain
Santiago de Compostela La Coruna, 15706, Spain
Alcorcón Madrid, 28922, Spain
Badalona , 08916, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Cadiz , 11407, Spain
Córdoba , 14004, Spain
Lugo , 27003, Spain
Madrid , 28033, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Málaga , 29010, Spain
Sevilla , 41009, Spain
Kaohsiung , 81362, Taiwan
Kaohsiung , 833, Taiwan
Taichung City , 404, Taiwan
Taichung , 407, Taiwan
Tainan City , 710, Taiwan
Tainan , 704, Taiwan
Taipei city , 11217, Taiwan
Taoyuan , 333, Taiwan
Dnipro , 49005, Ukraine
Dnipro , 49102, Ukraine
Kyiv , 02125, Ukraine
Luts'k , 43018, Ukraine
London England, SE1 9, United Kingdom
Somerset England, TA1 5, United Kingdom
Surrey Quays England, SM2 5, United Kingdom
Blackburn Lancashire, BB2 3, United Kingdom
Northwood Middlesex, HA6 2, United Kingdom
Swansea Wales, SA2 Q, United Kingdom
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