CONTACT-02: Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

Sponsor
Exelixis (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04446117
Collaborator
Roche-Genentech (Industry), Takeda (Industry)
580
233
2
37
2.5
0.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
580 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Approximately 580 eligible subjects will be randomized in a 1:1 fashion to the experimental arm receiving cabozantinib and atezolizumab in combination (290) or to the control arm receiving a second NHT (290).Approximately 580 eligible subjects will be randomized in a 1:1 fashion to the experimental arm receiving cabozantinib and atezolizumab in combination (290) or to the control arm receiving a second NHT (290).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date :
Jun 30, 2020
Anticipated Primary Completion Date :
Mar 30, 2022
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Arm

Subjects with mCRPC will receive cabozantinib 40mg oral, qd + atezolizumab 1200mg infusion, q3w

Drug: Cabozantinib
Supplied as 20-mg tablets; administered orally daily at 40mg
Other Names:
  • XL184
  • Cabometyx®
  • Drug: Atezolizumab
    Supplied as 1200 mg/20 mL vials; administered as an IV infusion once every 3 weeks (q3w)
    Other Names:
  • Tecentriq®
  • Active Comparator: Control Arm

    Subjects with mCRPC will receive active comparator of EITHER abiraterone 1000mg oral, qd + prednisone 5 mg oral, bid; OR enzalutamide 160mg oral, qd as designated by the Investigator prior to randomization

    Drug: Abiraterone Acetate
    Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid
    Other Names:
  • Abiraterone
  • Zytiga
  • Drug: Enzalutamide
    Supplied as 40 mg capsules; administered orally daily at 160mg
    Other Names:
  • Xtandi
  • Drug: Prednisone
    Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily

    Outcome Measures

    Primary Outcome Measures

    1. Duration of Progression Free Survival per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1) [Approximately 21 months after the first subject is randomized.]

      Defined as time from randomization to the earlier of progressive disease (PD) per RECIST 1.1 as determined by the Blinded Independent Radiology Committee (BIRC) or death from any cause

    2. Duration of Overall Survival (OS) [Approximately 37 months after the first subject is randomized]

      Defined as time from randomization to date of death from any cause

    Secondary Outcome Measures

    1. Objective response rate (ORR) [Approximately 37 months after the first subject is randomized]

      ORR per RECIST 1.1 by BIRC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Exelixis Clinical Site #4 Tucson Arizona United States 85741
    2 Exelixis Clinical Site #42 Duarte California United States 91010
    3 Exelixis Clinical Site #2 Fullerton California United States 92835
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    5 Exelixis Clinical Site #114 San Diego California United States 92161
    6 Exelixis Clinical Site #125 Santa Monica California United States 90404
    7 Exelixis Clinical Site #91 Aurora Colorado United States 80045
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    9 Exelixis Clinical Site #108 Miami Florida United States 33125
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    14 Exelixis Clinical Site #144 Las Vegas Nevada United States 89169
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    16 Exelixis Clinical Site #198 Bronx New York United States 10461
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    21 Exelixis Clinical Site #1 Nashville Tennessee United States 37209
    22 Exelixis Clinical Site #5 Houston Texas United States 77027
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    40 Exelixis Clinical Site # 189 Sydney New South Wales Australia 2109
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    42 Exelixis Clinical Site #103 Launceston Tasmania Australia 7250
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    44 Exelixis Clinical Site #95 Frankston Victoria Australia 3199
    45 Exelixis Clinical Site #53 Melbourne Victoria Australia 3000
    46 Exelixis Clinical Site #115 Adelaide Australia 5000
    47 Exelixis Clinical Site #149 Box Hill Australia 3128
    48 Exelixis Site #158 Linz Oberösterreich Austria 4020
    49 Odensklinikum Linz GmbH Elisabethinen #156 Linz Oberösterreich Austria 4020
    50 Exelixis Clinical Site #218 Wien Austria 1080
    51 Exelixis Clinical Site #126 Bonheiden Antwerpen Belgium 2820
    52 Exelixis Clinical Site #39 Gent Oost-Vlaanderen Belgium 9000
    53 Exelixis Clinical Site #141 Brussels Belgium 1000
    54 Exelixis Site #165 Roeselare Belgium 8800
    55 Exelixis Clinical Site #204 Curitiba Parana Brazil 80520-174
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    59 Exelixis Clinical Site #132 Blumenau Santa Catarina Brazil 89010-340
    60 Exelixis Clinical Site #191 Campinas Sao Paulo Brazil 13083-970
    61 Exelixis Site #161 Sao Paulo SP Brazil 04538-132
    62 Exelixis Clinical Site #128 Ribeirão Preto São Paulo Brazil 14048-900
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    64 Exelixis Clinical Site #154 Barretos Brazil 14784-400
    65 Exelixis Clinical Site #140 Fortaleza Brazil 60336-232
    66 Exelixis Clinical Site #153 Porto Alegre Brazil 90110-270
    67 Exelixis Clinical Site #145 Ribeirão Preto Brazil 14015-130
    68 Exelixis Clinical Site #116 Santa Cruz Do Sul Brazil 96810-110
    69 Exelixis Clinical Site #69 Edmonton Alberta Canada T6G 1Z2
    70 Exelixis Clinical Site #112 Kelowna British Columbia Canada V1Y 5L3
    71 Exelixis Clinical Site #147 Moncton New Brunswick Canada E1C 6Z8
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    77 Exelixis Clinical Site #139 Santiago de Chile Región Metropolitana De Santiago Chile 7500921
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    83 Exelixis Clinical Site #63 Praha 2 Praha Czechia 120 00
    84 Exelixis Clinical Site #129 Brno Czechia 656 91
    85 Exelixis Clinical Site #130 Olomouc Czechia 779 00
    86 Exelixis Clinical Site #80 Praha 2 Czechia 128 00
    87 Exelixis Clinical Site #47 Praha 8 Czechia 180 81
    88 Exelixis Clinical Site #31 Praha Czechia 140 59
    89 Exelixis Clinical Site #134 Brest France 29229
    90 Exelixis Clinical Site #77 Clermont-Ferrand France 63011
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    92 Exelixis Clinical Site #74 Hyères France 83400
    93 Exelixis Clinical Site #222 La Roche-sur-Yon Cedex 9 France 85925
    94 Exelixis Clinical Site #146 Nîmes France 30029
    95 Exelixis Clinical Site #38 Paris France 75015
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    99 Exelixis Clinical Site #212 Strasbourg France 67000
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    104 Exelixis Clinical Site #16 Tbilisi Georgia 0112
    105 Exelixis Clinical Site #9 Tbilisi Georgia 0141
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    110 Exelixis Clinical Site #176 Nürtingen Baden-Wuerttemberg Germany 72622
    111 Exelixis Clinical Site #98 Gutersloh Nordrhein-Westfalen Germany 33332
    112 Exelixis Clinical Site #180 Duisburg North Rhine-Westphalia Germany 47179
    113 Exelixis Clinical Site #179 Münster North Rhine-Westphalia Germany 48149
    114 Exelixis Clinical Site #185 Lübeck Schleswig-Holstein Germany 23538
    115 Exelixis Clinical Site #228 Berlin Germany 10117
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    117 Exelixis Clinical Site #93 Cholargós Attica Greece 15562
    118 Exelixis Clinical Site #202 Maroussi Attica Greece 15123
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    120 Exelixis Clinical Site #99 Néo Fáliro Attica Greece 18547
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    129 Exelixis Clinical Site #55 Haifa Israel 3109601
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    131 Exelixis Clinical Site #150 Petah tikva Israel 4941492
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    133 Exelixis Clinical Site #30 Safed Israel 1311001
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    137 Exelixis Clinical Site #199 Trento Trentino Italy 38122
    138 Exelixis Clinical Site #217 Ancona Italy 60126
    139 Exelixis Clinical Site #121 Firenze Italy 50134
    140 Exelixis Clinical Site #192 Milan Italy 20132
    141 Exelixis Clinical Site #107 Perugia Italy 06132
    142 Exelixis Clinical Site #62 Roma Italy 00144
    143 Exelixis Clinical Site #234 Roma Italy 00168
    144 Exelixis Clinical Site #96 Terni Italy 05100
    145 Exelixis Clinical Site #233 Toyohashi Aichi Japan 471-8513
    146 Exelixis Clinical Site #100 Akita-Shi Akita Japan 010-8543
    147 Exelixis Clinical Site #104 Hirosaki Aomori Japan 036-8563
    148 Exelixis Clinical Site #43 Kashiwa-shi Chiba Japan 277-8577
    149 Exelixis Clinical Site #54 Sakura-shi Chiba Japan 285-8741
    150 Exelixis Clinical Site #72 Sapporo Hokkaido Japan 060-8543
    151 Exelixis Clinical Site #37 Sapporo Hokkaido Japan 060-8648
    152 Exelixis Clinical Site #70 Kobe Hyogo Japan 650-0017
    153 Exelixis Clinical Site #52 Kobe Hyogo Japan 650-0047
    154 Exelixis Clinical Site #84 Kita-gun Kagawa Japan 761-0793
    155 Exelixis Clinical Site #68 Sagamihara Kanagawa Japan 252-0375
    156 Exelixis Clinical Site #22 Yokohama-shi Kanagawa Japan 232-0024
    157 Exelixis Clinical Site #211 Natori-shi Miyagi Japan 981-1293
    158 Exelixis Clinical Site #88 Chuo-Ku Osaka-shi Japan 541-8567
    159 Exelixis Clinical Site #51 Hidaka Saitama Japan 350-1298
    160 Exelixis Clinical Site #214 Shizuoka City Shizuoka Japan 420-8527
    161 Exelixis Clinical Site #65 Shinjuku-Ku Tokyo Japan 160-8582
    162 Exelixis Clinical Site #61 Ube Yamaguchi Japan 755-8505
    163 Exelixis Clinical Site #78 Chiba Japan 260-8717
    164 Exelixis Clinical Site #209 Fukuoka Japan 815-8588
    165 Exelixis Clinical Site #26 Nagano Japan 381-8551
    166 Exelixis Clinical Site #75 Tokyo Japan 135-8550
    167 Exelixis Clinical Site #32 Wakayama Japan 641-8510
    168 Exelixis Clinical Site #81 Ōsaka-sayama Japan 589-8511
    169 Exelixis Clinical Site #20 Junggu Daejeon Korea, Republic of 35015
    170 Exelixis Clinical Site #49 Goyang-si Gyeonggi-do Korea, Republic of 10408
    171 Exelixis Clinical Site #60 Seongnam-si Gyeonggi-Do Korea, Republic of 13620
    172 Exelixis Clinical Site #34 Hwasun Jeollanam-do Korea, Republic of 58128
    173 Exelixis Clinical Site #58 Busan Korea, Republic of 47392
    174 Exelixis Clinical Site #24 Busan Korea, Republic of 49241
    175 Exelixis Clinical Site #94 Daegu Korea, Republic of 41404
    176 Exelixis Clinical Site #21 Daegu Korea, Republic of 42601
    177 Exelixis Clinical Site #40 Gwangju Korea, Republic of 61469
    178 Exelixis Clinical Site #59 Seoul Korea, Republic of 03080
    179 Exelixis Clinical Site #46 Seoul Korea, Republic of 03722
    180 Exelixis Clinical Site #25 Seoul Korea, Republic of 06273
    181 Exelixis Clinical Site #48 Seoul Korea, Republic of 06351
    182 Exelixis Clinical Site #206 Tuxtla Gutiérrez Chiapas Mexico 29038
    183 Exelixis Clinical Site #187 Mexico City Distrito Federal Mexico 06760
    184 Exelixis Clinical Site #215 Guadalajara Jalisco Mexico 44500
    185 Exelixis Clinical Site #173 Guadalajara Jalisco Mexico 44600
    186 Exelixis Clinical Site #219 Zapopan Jalisco Mexico 45040
    187 Exelixis Clinical Site #172 Querétaro Queretaro Mexico 76070
    188 Exelixis Clinical Site #182 Querétaro Queretaro Mexico 76230
    189 Exelixis Clinical Site #184 San Luis Potosí San Luis Potosi Mexico 78209
    190 Exelixis Clinical Site #208 Culiacán Sinaloa Mexico C.P. 80020
    191 Exelixis Clinical Site #174 Mexico City Mexico 01120
    192 Exelixis Clinical Site #82 Bydgoszcz Poland 85-796
    193 Exelixis Clinical Site #89 Poznań Poland 60-569
    194 Exelixis Clinical Site #110 Braga Portugal 4710-243
    195 Exelixis Clinical Site #188 Guimarães Portugal 4835-044
    196 Exelixis Site #164 Lisboa Portugal 1400-038
    197 Exelixis Clinical Site #197 Lisboa Portugal 1500-650
    198 Exelixis Clinical Site #196 Loures Portugal 2674-514
    199 Exelixis Clinical Site #56 Porto Portugal 4099-001
    200 Exelixis Clinical Site #224 Porto Portugal 4200-072
    201 Exelixis Clinical Site #193 Vila Real Portugal 5000-508
    202 Exelixis Site #166 Moscow Russian Federation 115478
    203 Exelixis Clinical Site #137 Saint Petersburg Russian Federation 197022
    204 Exelixis Clinical Site #195 Saint Petersburg Russian Federation 197758
    205 Exelixis Clinical Site #50 Singapore Singapore 169610
    206 Exelixis Clinical Site #87 Singapore Singapore 258499
    207 Exelixis Clinical Site #181 Singapore Singapore 329563
    208 Exelixis Clinical Site #232 Santiago De Compostela A Coruna Spain 15706
    209 Exelixis Clinical Site #229 Elche Alicante Spain 03203
    210 Exelixis Clinical Site #223 Oviedo Asturias Spain 33011
    211 Exelixis Clinical Site #12 Manresa Barcelona Spain 08243
    212 Exelixis Clinical Site #220 Palma De Mallorca Islas Baleares Spain 07120
    213 Exelixis Clinical Site #17 Alcorcón Madrid Spain 28922
    214 Exelixis Clinical Site #227 Barcelona Spain 08003
    215 Exelixis Clinical Site #23 Barcelona Spain 08035
    216 Exelixis Clinical Site #190 Barcelona Spain 08041
    217 Exelixis Clinical Site #226 Cadiz Spain 11407
    218 Exelixis Clinical Site #33 Córdoba Spain 14004
    219 Exelixis Clinical Site #28 Lugo Spain 27003
    220 Exelixis Clinical Site #131 Madrid Spain 28033
    221 Exelixis Clinical Site #13 Madrid Spain 28050
    222 Exelixis Clinical Site #29 Sevilla Spain 41009
    223 Exelixis Clinical Site #138 Kaohsiung Taiwan 833
    224 Exelixis Clinical Site #86 Taichung City Taiwan 404
    225 Exelixis Clinical Site #133 Taichung Taiwan 407
    226 Exelixis Clinical Site #111 Tainan Taiwan 704
    227 Exelixis Clinical Site #102 Dnipro Ukraine 49005
    228 Exelixis Clinical Site #186 Dnipro Ukraine 49102
    229 Exelixis Clinical Site #76 Kyiv Ukraine 02125
    230 Exelixis Clinical Site #71 Luts'k Ukraine 43018
    231 Exelixis Clinical Site #205 London England United Kingdom SE1 9RT
    232 Exelixis Clinical Site #231 Northwood Middlesex United Kingdom HA6 2RN
    233 Exelixis Clinical Site #194 Swansea Wales United Kingdom SA2 Q8A

    Sponsors and Collaborators

    • Exelixis
    • Roche-Genentech
    • Takeda

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Exelixis
    ClinicalTrials.gov Identifier:
    NCT04446117
    Other Study ID Numbers:
    • XL184-315
    First Posted:
    Jun 24, 2020
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Exelixis
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022