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.

View Full Description

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.

View Eligibility Criteria

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).

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

580

Study ID:

NCT04446117

Recruitment Status:

Recruiting

Sponsor:

Exelixis

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There are 254 Locations for this study

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Exelixis Clinical Site #4
Tucson Arizona, 85741, United States
Exelixis Clinical Site #42
Duarte California, 91010, United States
Exelixis Clinical Site #2
Fullerton California, 92835, United States
Exelixis Clinical Site #225
La Jolla California, 92093, United States
Exelixis Clinical Site #114
San Diego California, 92161, United States
Exelixis Clinical Site #125
Santa Monica California, 90404, United States
Exelixis Clinical Site #246
Stanford California, 94305, United States
Exelixis Clinical Site #91
Aurora Colorado, 80045, United States
Exelixis Clinical Site #14
Denver Colorado, 80211, United States
Exelixis Clinical Site #108
Miami Florida, 33125, United States
Exelixis Clinical Site #216
Westwood Kansas, 66205, United States
Exelixis Clinical Site #243
Louisville Kentucky, 40202, United States
Exelixis Clinical Site #6
Baltimore Maryland, 21204, United States
Exelixis Clinical Site #203
Rochester Minnesota, 55905, United States
Exelixis Clinical Site #19
Omaha Nebraska, 68130, United States
Exelixis Clinical Site #144
Las Vegas Nevada, 89169, United States
Exelixis Clinical Site #123
East Brunswick New Jersey, 08816, United States
Exelixis Clinical Site #198
Bronx New York, 10461, United States
Exelixis Site #159
Cleveland Ohio, 44195, United States
Exelixis Clinical Site #221
Oklahoma City Oklahoma, 73104, United States
Exelixis Clinical Site #18
Philadelphia Pennsylvania, 19111, United States
Exelixis Clinical Site #201
Pittsburgh Pennsylvania, 15232, United States
Exelixis Clinical Site #1
Nashville Tennessee, 37209, United States
Exelixis Clinical Site #5
Houston Texas, 77027, United States
Exelixis Clinical Site #177
Houston Texas, 77030, United States
Exelixis Clinical Site #258
Houston Texas, 77030, United States
Exelixis Clinical Site #41
Temple Texas, 76504, United States
Exelixis Clinical Site #67
Salt Lake City Utah, 84112, United States
Exelixis Clinical Site #143
Roanoke Virginia, 24014, United States
Exelixis Clinical Site #122
Ciudad Autonoma de Buenos Aire Buenos Aires, C1280, Argentina
Exelixis Clinical Site #120
Mar Del Plata Buenos Aires, B7600, Argentina
Exelixis Site #170
Pergamino Buenos Aires, B2700, Argentina
Exelixis Clinical Site #210
Córdoba Cordoba, X5004, Argentina
Exelixis Clinical Site #152
Viedma Rio Negro, R8500, Argentina
Exelixis Clinical Site #183
Rosario Santa Fe, S2000, Argentina
Exelixis Clinical Site #200
Buenos Aires , C1426, Argentina
Exelixis Clinical Site #257
Caba , C1120, Argentina
Exelixis Clinical Site #44
Ciudad Autonoma de Buenos Aire , C1012, Argentina
Exelixis Clinical Site #105
La Rioja , F5300, Argentina
Exelixis Clinical Site #124
San Juan , 5400, Argentina
Exelixis Clinical Site #101
San Salvador De Jujuy , Y4600, Argentina
Exelixis Clinical Site #151
Garran Australian Capital Territory, 2605, Australia
Exelixis Clinical Site #252
Port Macquarie New South Wales, 2444, Australia
Exelixis Clinical Site #175
Saint Leonards New South Wales, 2065, Australia
Exelixis Clinical Site # 189
Sydney New South Wales, 2109, Australia
Exelixis Site #162
Wollongong New South Wales, 2500, Australia
Exelixis Clinical Site #254
Chermside Queensland, 4032, Australia
Exelixis Clinical Site #103
Launceston Tasmania, 7250, Australia
Exelixis Clinical Site #79
Ballarat Victoria, 3350, Australia
Exelixis Clinical Site #95
Frankston Victoria, 3199, Australia
Exelixis Clinical Site #53
Melbourne Victoria, 3000, Australia
Exelixis Clinical #261
St Albans Victoria, 3021, Australia
Exelixis Clinical Site #115
Adelaide , 5000, Australia
Exelixis Clinical Site #149
Box Hill , 3128, Australia
Exelixis Site #158
Linz Oberösterreich, 4020, Austria
Odensklinikum Linz GmbH Elisabethinen #156
Linz Oberösterreich, 4020, Austria
Exelixis Clinical Site #218
Wien , 1080, Austria
Exelixis Clinical Site #126
Bonheiden Antwerpen, 2820, Belgium
Exelixis Clinical Site #39
Gent Oost-Vlaanderen, 9000, Belgium
Exelixis Clinical Site #141
Brussels , 1000, Belgium
Exelixis Site #165
Roeselare , 8800, Belgium
Exelixis Clinical Site #204
Curitiba Parana, 80520, Brazil
Exelixis Site #163
Curitiba Paraná, 80510, Brazil
Exelixis Site #157
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Exelixis Clinical Site #171
Rio De Janeiro RJ, 22793, Brazil
Exelixis Clinical Site #132
Blumenau Santa Catarina, 89010, Brazil
Exelixis Clinical Site #191
Campinas Sao Paulo, 13083, Brazil
Exelixis Site #161
Sao Paulo SP, 04538, Brazil
Exelixis Clinical Site #249
São Paulo SP, 03102, Brazil
Exelixis Clinical Site #128
Ribeirão Preto São Paulo, 14048, Brazil
Exelixis Clinical Site #106
São José Do Rio Preto São Paulo, 15090, Brazil
Exelixis Clinical Site #154
Barretos , 14784, Brazil
Exelixis Clinical Site #140
Fortaleza , 60336, Brazil
Exelixis Clinical Site #153
Porto Alegre , 90110, Brazil
Exelixis Clinical Site #145
Ribeirão Preto , 14015, Brazil
Exelixis Clinical Site #116
Santa Cruz Do Sul , 96810, Brazil
Exelixis Clinical Site #69
Edmonton Alberta, T6G 1, Canada
Exelixis Clinical Site #112
Kelowna British Columbia, V1Y 5, Canada
Exelixis Clinical Site #147
Moncton New Brunswick, E1C 6, Canada
Exelixis Clinical Site #83
Hamilton Ontario, L8V 5, Canada
Exelixis Clinical Site #127
London Ontario, N6A 5, Canada
Exelixis Clinical Site #7
Oakville Ontario, L6H 3, Canada
Exelixis Clinical Site #178
Granby Quebec, J2GIT, Canada
Exelixis Site #160
Montréal Quebec, H2X 3, Canada
Exelixis Clinical Site #139
Santiago de Chile Región Metropolitana De Santiago, 75009, Chile
Exelixis Clinical Site #248
Viña Del Mar Valparaiso, 25205, Chile
Exelixis Clinical Site #142
Providencia , 75007, Chile
Exelixis Clinical Site #148
Recoleta , 84203, Chile
Exelixis Clinical Site #90
Santiago , 75006, Chile
Exelixis Clinical Site #113
Temuco , 48104, Chile
Exelixis Clinical Site #119
Valparaíso , 25403, Chile
Exelixis Clinical Site #63
Praha 2 Praha, 120 0, Czechia
Exelixis Clinical Site #129
Brno , 656 9, Czechia
Exelixis Clinical Site #130
Olomouc , 779 0, Czechia
Exelixis Clinical Site #80
Praha 2 , 128 0, Czechia
Exelixis Clinical Site #47
Praha 8 , 180 8, Czechia
Exelixis Clinical Site #31
Praha , 140 5, Czechia
Exelixis Clinical Site #134
Brest , 29229, France
Exelixis Clinical Site #77
Clermont-Ferrand , 63011, France
Exelixis Clinical Site #155
Dijon cedex , 21079, France
Exelixis Clinical Site #74
Hyères , 83400, France
Exelixis Clinical Site #222
La Roche-sur-Yon Cedex 9 , 85925, France
Exelixis Clinical Site #146
Nîmes , 30029, France
Exelixis Clinical Site #38
Paris , 75015, France
Exelixis Clinical Site #66
Quimper , 29107, France
Exelixis Clinical Site #213
Reims Cedex , 51726, France
Exelixis Clinical Site #135
Saint-Grégoire , 35760, France
Exelixis Clinical Site #212
Strasbourg , 67000, France
Exelixis Clinical Site #36
Strasbourg , 67200, France
Exelixis Clinical Site #73
Toulouse , 31059, France
Exelixis Clinical Site #85
Toulouse , 31076, France
Exelixis Clinical Site #230
Vandoeuvre les nancy , 54511, France
Exelixis Clinical Site #16
Tbilisi , 0112, Georgia
Exelixis Clinical Site #9
Tbilisi , 0141, Georgia
Exelixis Clinical Site #10
Tbilisi , 0144, Georgia
Exelixis Clinical Site #11
Tbilisi , 0159, Georgia
Exelixis Clinical Site #15
Tbilisi , 0167, Georgia
Exelixis Clinical Site #8
Tbilisi , 0186, Georgia
Exelixis Clinical Site #176
Nürtingen Baden-Wuerttemberg, 72622, Germany
Exelixis Clinical Site #98
Gutersloh Nordrhein-Westfalen, 33332, Germany
Exelixis Clinical Site #180
Duisburg North Rhine-Westphalia, 47179, Germany
Exelixis Clinical Site #179
Münster North Rhine-Westphalia, 48149, Germany
Exelixis Clinical Site #185
Lübeck Schleswig-Holstein, 23538, Germany
Exelixis Clinical Site #228
Berlin , 10117, Germany
Exelixis Clinical Site #238
Hamburg , 20246, Germany
Exelixis Clinical Site #136
Tübingen , 72076, Germany
Exelixis Clinical Site #239
Athens Attica, 11526, Greece
Exelixis Clinical Site #93
Cholargós Attica, 15562, Greece
Exelixis Clinical Site #202
Maroussi Attica, 15123, Greece
Exelixis Clinical Site #92
Maroúsi Attica, 15125, Greece
Exelixis Clinical Site #242
Néa Kifisiá Attica, 14564, Greece
Exelixis Clinical Site #99
Néo Fáliro Attica, 18547, Greece
Exelixis Clinical Site #45
Heraklion Crete, 71110, Greece
Exelixis Clinical Site #64
Thessaloníki Macedonia, 54007, Greece
Exelixis Clinical Site #97
Larissa Thessaly, 41110, Greece
Exelixis Clinical Site #118
Budapest , 1062, Hungary
Exelixis Clinical Site #207
Budapest , 1082, Hungary
Exelixis Clinical Site #57
Budapest , 1122, Hungary
Exelixis Clinical Site #109
Budapest , 1145, Hungary
Exelixis Clinical Site #240
Debrecen , 4032, Hungary
Exelixis site #167
Gyula , 5700, Hungary
Exelixis Clinical Site #55
Haifa , 31096, Israel
Exelixis Clinical Site #27
Jerusalem , 91120, Israel
Exelixis Clinical Site #150
Petah tikva , 49414, Israel
Exelixis Clinical Site #117
Ramat Gan , 52656, Israel
Exelixis Clinical Site #30
Safed , 13110, Israel
Exelixis Clinical Site #35
Tel Aviv , 64239, Israel
Exelixis Site #168
Meldola FC, 47014, Italy
Exelixis Clinical Site #245
Rozzano Milan, 20089, Italy
Exelixis Site #156
Sondrio SO, 23100, Italy
Exelixis Clinical Site #199
Trento Trentino, 38122, Italy
Exelixis Clinical Site #217
Ancona , 60126, Italy
Exelixis Clinical Site #121
Firenze , 50134, Italy
Exelixis Clinical Stie #260
Milano , 20133, Italy
Exelixis Clinical Site #192
Milan , 20132, Italy
Exelixis Clinical Site #237
Pavia , 27100, Italy
Exelixis Clinical Site #107
Perugia , 06132, Italy
Exelixis Clinical Site #62
Roma , 00144, Italy
Exelixis Clinical Site #234
Roma , 00168, Italy
Exelixis Clinical Site #96
Terni , 05100, Italy
Exelixis Clinical Site #233
Toyohashi Aichi, 471-8, Japan
Exelixis Clinical Site #100
Akita-Shi Akita, 010-8, Japan
Exelixis Clinical Site #104
Hirosaki Aomori, 036-8, Japan
Exelixis Clinical Site #43
Kashiwa-shi Chiba, 277-8, Japan
Exelixis Clinical Site #54
Sakura-shi Chiba, 285-8, Japan
Exelixis Clinical Site #72
Sapporo Hokkaido, 060-8, Japan
Exelixis Clinical Site #37
Sapporo Hokkaido, 060-8, Japan
Exelixis Clinical Site #70
Kobe Hyogo, 650-0, Japan
Exelixis Clinical Site #52
Kobe Hyogo, 650-0, Japan
Exelixis Clinical Site #84
Kita-gun Kagawa, 761-0, Japan
Exelixis Clinical Site #68
Sagamihara Kanagawa, 252-0, Japan
Exelixis Clinical Site #22
Yokohama-shi Kanagawa, 232-0, Japan
Exelixis Clinical Site #211
Natori-shi Miyagi, 981-1, Japan
Exelixis Clinical Site #88
Chuo-Ku Osaka-shi, 541-8, Japan
Exelixis Clinical Site #51
Hidaka Saitama, 350-1, Japan
Exelixis Clinical Site #214
Shizuoka City Shizuoka, 420-8, Japan
Exelixis Clinical Site #65
Shinjuku-Ku Tokyo, 160-8, Japan
Exelixis Clinical Site #61
Ube Yamaguchi, 755-8, Japan
Exelixis Clinical Site #78
Chiba , 260-8, Japan
Exelixis Clinical Site #209
Fukuoka , 815-8, Japan
Exelixis Clinical Site #26
Nagano , 381-8, Japan
Exelixis Clinical Site #75
Tokyo , 135-8, Japan
Exelixis Clinical Site #32
Wakayama , 641-8, Japan
Exelixis Clinical Site #81
Ōsaka-sayama , 589-8, Japan
Exelixis Clinical Site #20
Junggu Daejeon, 35015, Korea, Republic of
Exelixis Clinical Site #49
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Exelixis Clinical Site #60
Seongnam-si Gyeonggi-Do, 13620, Korea, Republic of
Exelixis Clinical Site #34
Hwasun Jeollanam-do, 58128, Korea, Republic of
Exelixis Clinical Site #58
Busan , 47392, Korea, Republic of
Exelixis Clinical Site #24
Busan , 49241, Korea, Republic of
Exelixis Clinical Site #94
Daegu , 41404, Korea, Republic of
Exelixis Clinical Site #21
Daegu , 42601, Korea, Republic of
Exelixis Clinical Site #40
Gwangju , 61469, Korea, Republic of
Exelixis Clinical Site #59
Seoul , 03080, Korea, Republic of
Exelixis Clinical Site #46
Seoul , 03722, Korea, Republic of
Exelixis Clinical Site #25
Seoul , 06273, Korea, Republic of
Exelixis Clinical Site #48
Seoul , 06351, Korea, Republic of
Exelixis Clinical Site #206
Tuxtla Gutiérrez Chiapas, 29038, Mexico
Exelixis Clinical Site #187
Mexico City Distrito Federal, 06760, Mexico
Exelixis Clinical Site #255
León Guanajuato, 37178, Mexico
Exelixis Clinical Site #215
Guadalajara Jalisco, 44500, Mexico
Exelixis Clinical Site #173
Guadalajara Jalisco, 44600, Mexico
Exelixis Clinical Site #219
Zapopan Jalisco, 45040, Mexico
Exelixis Clinical Site #259
Monterrey Nuevo Leon, 64710, Mexico
Exelixis Clinical Site #172
Querétaro Queretaro, 76070, Mexico
Exelixis Clinical Site #182
Querétaro Queretaro, 76230, Mexico
Exelixis Clinical Site #250
San Luis Potosí San Luis Potosi, 78200, Mexico
Exelixis Clinical Site #184
San Luis Potosí San Luis Potosi, 78209, Mexico
Exelixis Clinical Site #208
Culiacán Sinaloa, C.P. , Mexico
Exelixis Clinical Site #174
Mexico City , 01120, Mexico
Exelixis Clinical Site #244
Otwock Mazowieckie, 05-40, Poland
Exelixis Clinical Site #82
Bydgoszcz , 85-79, Poland
Exelixis Clinical Site #89
Poznań , 60-56, Poland
Exelixis Clinical Site #110
Braga , 4710-, Portugal
Exelixis Clinical Site #188
Guimarães , 4835-, Portugal
Exelixis Site #164
Lisboa , 1400-, Portugal
Exelixis Clinical Site #197
Lisboa , 1500-, Portugal
Exelixis Clinical Site #196
Loures , 2674-, Portugal
Exelixis Clinical Site #56
Porto , 4099-, Portugal
Exelixis Clinical Site #224
Porto , 4200-, Portugal
Exelixis Clinical Site #193
Vila Real , 5000-, Portugal
Exelixis Site #166
Moscow , 11547, Russian Federation
Exelixis Clinical Site #137
Saint Petersburg , 19702, Russian Federation
Exelixis Clinical Site #195
Saint Petersburg , 19775, Russian Federation
Exelixis Clinical Site #50
Singapore , 16961, Singapore
Exelixis Clinical Site #87
Singapore , 25849, Singapore
Exelixis Clinical Site #181
Singapore , 32956, Singapore
Exelixis Clinical Site #232
Santiago De Compostela A Coruna, 15706, Spain
Exelixis Clinical Site #229
Elche Alicante, 03203, Spain
Exelixis Clinical Site #223
Oviedo Asturias, 33011, Spain
Exelixis Clinical Site #12
Manresa Barcelona, 08243, Spain
Exelixis Clinical Site #220
Palma De Mallorca Islas Baleares, 07120, Spain
Exelixis Clinical Site #17
Alcorcón Madrid, 28922, Spain
Exelixis Clinical Site #227
Barcelona , 08003, Spain
Exelixis Clinical Site #23
Barcelona , 08035, Spain
Exelixis Clinical Site #256
Barcelona , 08036, Spain
Exelixis Clinical Site #190
Barcelona , 08041, Spain
Exelixis Clinical Site #226
Cadiz , 11407, Spain
Exelixis Clinical Site #33
Córdoba , 14004, Spain
Exelixis Clinical Site #28
Lugo , 27003, Spain
Exelixis Clinical Site #131
Madrid , 28033, Spain
Exelixis Clinical Site #247
Madrid , 28040, Spain
Exelixis Clinical Site #236
Madrid , 28041, Spain
Exelixis Clinical Site #253
Madrid , 28046, Spain
Exelixis Clinical Site #13
Madrid , 28050, Spain
Exelixis Clinical Site #29
Sevilla , 41009, Spain
Exelixis Clinical Site #138
Kaohsiung , 833, Taiwan
Exelixis Clinical Site #86
Taichung City , 404, Taiwan
Exelixis Clinical Site #133
Taichung , 407, Taiwan
Exelixis Clinical Site #111
Tainan , 704, Taiwan
Exelixis Clinical Site #102
Dnipro , 49005, Ukraine
Exelixis Clinical Site #186
Dnipro , 49102, Ukraine
Exelixis Clinical Site #76
Kyiv , 02125, Ukraine
Exelixis Clinical Site #71
Luts'k , 43018, Ukraine
Exelixis Clinical Site #205
London England, SE1 9, United Kingdom
Exelixis Clinical Site #241
Somerset England, TA1 5, United Kingdom
Exelixis Clinical Site #235
Surrey Quays England, SM2 5, United Kingdom
Exelixis Clinical Site #251
Blackburn Lancashire, BB2 3, United Kingdom
Exelixis Clinical Site #231
Northwood Middlesex, HA6 2, United Kingdom
Exelixis Clinical Site #194
Swansea Wales, SA2 Q, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

580

Study ID:

NCT04446117

Recruitment Status:

Recruiting

Sponsor:


Exelixis

How clear is this clinincal trial information?

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