Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

NCT04446117 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 1 other identifier: XL184-315
• Study Type: interventional
• Target: 575
• Locations: 26 countries
• Sites: 266

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.

Conditions

Metastatic Prostate Cancer; Prostate Adenocarcinoma

Keywords

prostate cancer; castration-resistant prostate cancer

Outcome Measures

Primary Outcomes (2)

• Duration of Progression Free Survival (PFS) Per Response Evaluable Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Radiology Committee (BIRC)

  Duration of PFS was defined as the time from randomization to the earlier of either the date of radiographic progression (defined as progressive disease \[PD\] per RECIST 1.1) per BIRC or the date of death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions, with an absolute increase of ≥ 5 mm, unequivocal progression of non-target lesions and/or the appearance of new lesions.

  Up to a maximum of approximately 30 months (Median duration of follow-up was 14.31 months)

• Duration of Overall Survival (OS)

  Duration of OS was defined as the time from randomization to death due to any cause. For participants, who were not known to have died at the time of data cutoff and were permanently lost to follow-up, duration of OS was censored at the earlier of the following dates: date the participant was last known to be alive or date of full withdrawal of consent (including survival follow-up), or date of data cutoff. OS was calculated as earlier of date of death or censoring - date of randomization + 1)/30.4375

  Up to a maximum of approximately 45 months (Median duration of follow-up was 24.05 months)

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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

Drug: Cabozantinib; Drug: Atezolizumab

Control Arm

ACTIVE COMPARATOR

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; Drug: Enzalutamide; Drug: Prednisone

Interventions

Enzalutamide DRUG

Supplied as 40 mg capsules; administered orally daily at 160mg

Also known as: Xtandi

Control Arm

Prednisone DRUG

Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily

Control Arm

Cabozantinib DRUG

Supplied as 20-mg tablets; administered orally daily at 40mg

Also known as: XL184, Cabometyx®

Experimental Arm

Atezolizumab DRUG

Supplied as 1200 mg/20 mL vials; administered as an IV infusion once every 3 weeks (q3w)

Also known as: Tecentriq®

Experimental Arm

Abiraterone Acetate DRUG

Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid

Also known as: Abiraterone, Zytiga

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Exelixis: lead
• Roche-Genentech: collaborator
• Takeda: collaborator

Study Sites (280)

Exelixis Clinical Site #4

Tucson, Arizona, 85741, United States

Location

Exelixis Clinical Site #42

Duarte, California, 91010, United States

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Exelixis Clinical Site #2

Fullerton, California, 92835, United States

Location

Exelixis Clinical Site #224

La Jolla, California, 92093-0698, United States

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Exelixis Clinical Site #3

Marina del Rey, California, 90292, United States

Location

Exelixis Clinical Site #114

San Diego, California, 92161, United States

Location

Exelixis Clinical Site #125

Santa Monica, California, 90404, United States

Location

Exelixis Clinical Site #245

Stanford, California, 94305, United States

Location

Exelixis Clinical Site #91

Aurora, Colorado, 80045, United States

Location

Exelixis Clinical Site #14

Denver, Colorado, 80211, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Yale University, School of Medicine

New Haven, Connecticut, 06520, United States

Location

Exelixis Clinical Site #108

Miami, Florida, 33125, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Exelixis Clinical Site #215

Westwood, Kansas, 66205, United States

Location

Exelixis Clinical Site #242

Louisville, Kentucky, 40202, United States

Location

Exelixis Clinical Site #6

Baltimore, Maryland, 21204, United States

Location

Non-participating Site

Detroit, Michigan, 48202, United States

Location

Exelixis Clinical Site #203

Rochester, Minnesota, 55905, United States

Location

Exelixis Clinical Site #19

Omaha, Nebraska, 68130, United States

Location

Exelixis Clinical Site #144

Las Vegas, Nevada, 89169, United States

Location

Exelixis Clinical Site #123

East Brunswick, New Jersey, 08816, United States

Location

Non-participating Site

Lawrenceville, New Jersey, 08648, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Exelixis Clinical Site #198

The Bronx, New York, 10461, United States

Location

Exelixis Site #159

Cleveland, Ohio, 44195, United States

Location

Exelixis Clinical Site #221

Oklahoma City, Oklahoma, 73104, United States

Location

Exelixis Clinical Site #18

Philadelphia, Pennsylvania, 19111, United States

Location

Exelixis Clinical Site #201

Pittsburgh, Pennsylvania, 15232, United States

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Exelixis Clinical Site #1

Nashville, Tennessee, 37209, United States

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Exelixis Clinical Site #5

Houston, Texas, 77027, United States

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Exelixis Clinical Site #177

Houston, Texas, 77030, United States

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Exelixis Clinical Site #259

Houston, Texas, 77030, United States

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Exelixis Clinical Site #41

Temple, Texas, 76504, United States

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Exelixis Clinical Site #67

Salt Lake City, Utah, 84112, United States

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Exelixis Clinical Site #143

Roanoke, Virginia, 24014, United States

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Exelixis Clinical Site #122

Ciudad Autonoma de Buenos Aire, Buenos Aires, C1280AEB, Argentina

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Exelixis Clinical Site #120

Mar del Plata, Buenos Aires, B7600FZO, Argentina

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Exelixis Site #170

Pergamino, Buenos Aires, B2700CPM, Argentina

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Exelixis Clinical Site #210

Córdoba, Córdoba Province, X5004FHP, Argentina

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Exelixis Clinical Site #152

Viedma, Río Negro Province, R8500ACE, Argentina

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Exelixis Clinical Site #183

Rosario, Santa Fe Province, S2000CVB, Argentina

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Exelixis Clinical #261

Rosario, Santa Fe Province, S2000KZE, Argentina

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Exelixis Clinical Site #200

Buenos Aires, C1426ANZ, Argentina

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Exelixis Clinical Site #256

Caba, C1120AAT, Argentina

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Exelixis Clinical Site #44

Ciudad Autonoma de Buenos Aire, C1012AAR, Argentina

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Exelixis Clinical Site #105

La Rioja, F5300, Argentina

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Exelixis Clinical Site #124

San Juan, 5400, Argentina

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Exelixis Clinical Site #101

San Salvador de Jujuy, Y4600EHA, Argentina

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Exelixis Clinical Site #151

Garran, Australian Capital Territory, 2605, Australia

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Exelixis Clinical Site #252

Port Macquarie, New South Wales, 2444, Australia

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Exelixis Clinical Site #175

Saint Leonards, New South Wales, 2065, Australia

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Exelixis Clinical Site # 189

Sydney, New South Wales, 2109, Australia

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Exelixis Site #162

Wollongong, New South Wales, 2500, Australia

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Exelixis Clinical Site #253

Chermside, Queensland, 4032, Australia

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Exelixis Clinical Site #103

Launceston, Tasmania, 7250, Australia

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Exelixis Clinical Site #79

Ballarat, Victoria, 3350, Australia

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Exelixis Clinical Site #95

Frankston, Victoria, 3199, Australia

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Exelixis Clinical #262

Geelong, Victoria, 3220, Australia

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Exelixis Clinical Site #53

Melbourne, Victoria, 3000, Australia

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Exelixis Clinical Stie #260

Saint Albans, Victoria, 3021, Australia

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Exelixis Clinical Site #115

Adelaide, 5000, Australia

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Exelixis Clinical Site #149

Box Hill, 3128, Australia

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Exelixis Clinical Site #156

Linz, Upper Austria, 4020, Austria

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Exelixis Site #158

Linz, Upper Austria, 4020, Austria

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Exelixis Clinical Site #218

Vienna, 1080, Austria

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Exelixis Clinical Site #126

Bonheiden, Antwerpen, 2820, Belgium

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Exelixis Clinical Site #39

Ghent, Oost-Vlaanderen, 9000, Belgium

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Exelixis Clinical Site #141

Brussels, 1000, Belgium

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Exelixis Site #165

Roeselare, 8800, Belgium

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Exelixis Site #163

Curitiba, Paraná, 80510-130, Brazil

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Exelixis Clinical Site #204

Curitiba, Paraná, 80520-174, Brazil

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Exelixis Clinical Site #171

Rio de Janeiro, Rio de Janeiro, 22793-080, Brazil

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Exelixis Site #157

Porto Alegre, Rio Grande do Sul, 90610-00, Brazil

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Exelixis Clinical Site #132

Blumenau, Santa Catarina, 89010-340, Brazil

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Exelixis Clinical Site #191

Campinas, São Paulo, 13083-970, Brazil

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Exelixis Clinical Site #128

Ribeirão Preto, São Paulo, 14048-900, Brazil

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Exelixis Clinical Site #106

São José do Rio Preto, São Paulo, 15090-000, Brazil

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Exelixis Site #161

São Paulo, São Paulo, 04538-132, Brazil

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Exelixis Clinical Site #154

Barretos, 14784-400, Brazil

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Exelixis Clinical Site #140

Fortaleza, 60336-232, Brazil

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Exelixis Clinical Site #153

Porto Alegre, 90110-270, Brazil

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Exelixis Clinical Site #145

Ribeirão Preto, 14015-130, Brazil

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Exelixis Clinical Site #116

Santa Cruz do Sul, 96810-110, Brazil

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Exelixis Clinical Site #69

Edmonton, Alberta, T6G 1Z2, Canada

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Exelixis Clinical Site #112

Kelowna, British Columbia, V1Y 5L3, Canada

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Exelixis Clinical Site #147

Moncton, New Brunswick, E1C 6Z8, Canada

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Exelixis Clinical Site #83

Hamilton, Ontario, L8V 5C2, Canada

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Exelixis Clinical Site #127

London, Ontario, N6A 5W9, Canada

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Exelixis Clinical Site #7

Oakville, Ontario, L6H 3PI, Canada

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Exelixis Clinical Site #178

Granby, Quebec, J2GIT7, Canada

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Exelixis Site #160

Montreal, Quebec, H2X 3E4, Canada

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Exelixis Clinical Site #247

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Exelixis Clinical #263

Santiago, Santiago Metropolitan, 7500787, Chile

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Exelixis Clinical Site #139

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Exelixis Clinical Site #142

Providencia, 7500713, Chile

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Exelixis Clinical Site #148

Recoleta, 8420383, Chile

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Exelixis Clinical Site #90

Santiago, 7500653, Chile

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Exelixis Clinical Site #113

Temuco, 4810469, Chile

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Exelixis Clinical Site #119

Valparaíso, 2540333, Chile

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Exelixis Clinical Site #63

Prague, Prague, 120 00, Czechia

Location

Exelixis Clinical Site #129

Brno, 656 91, Czechia

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Exelixis Clinical Site #130

Olomouc, 779 00, Czechia

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Exelixis Clinical Site #80

Prague, 128 00, Czechia

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Exelixis Clinical Site #31

Prague, 140 59, Czechia

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Exelixis Clinical Site #47

Prague, 180 81, Czechia

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Exelixis Clinical Site #134

Brest, 29229, France

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Exelixis Clinical Site #77

Clermont-Ferrand, 63011, France

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Exelixis Clinical Site #155

Dijon, 21079, France

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Exelixis Clinical Site #74

Hyères, 83400, France

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Exelixis Clinical Site #222

La Roche-sur-Yon, 85925, France

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Exelixis Clinical Site #146

Nîmes, 30029, France

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Exelixis Clinical Site #38

Paris, 75015, France

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Exelixis Clinical Site #66

Quimper, 29107, France

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Exelixis Clinical Site #214

Reims, 51100, France

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Exelixis Clinical Site #135

Saint-Grégoire, 35760, France

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Exelixis Clinical Site #213

Strasbourg, 67000, France

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Exelixis Clinical Site #36

Strasbourg, 67200, France

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Exelixis Clinical Site #73

Toulouse, 31059, France

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Exelixis Clinical Site #85

Toulouse, 31076, France

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Exelixis Clinical Site #230

Vandœuvre-lès-Nancy, 54511, France

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Exelixis Clinical Site #16

Tbilisi, 0112, Georgia

Location

Exelixis Clinical Site #9

Tbilisi, 0141, Georgia

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Exelixis Clinical Site #10

Tbilisi, 0144, Georgia

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Exelixis Clinical Site #11

Tbilisi, 0159, Georgia

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Exelixis Clinical Site #15

Tbilisi, 0167, Georgia

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Exelixis Clinical Site #8

Tbilisi, 0186, Georgia

Location

Exelixis Clinical Site #176

Nürtingen, Baden-Wurttemberg, 72622, Germany

Location

Exelixis Clinical Site #180

Duisburg, North Rhine-Westphalia, 47179, Germany

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Exelixis Clinical Site #98

Gütersloh, North Rhine-Westphalia, 33332, Germany

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Exelixis Clinical Site #179

Münster, North Rhine-Westphalia, 48149, Germany

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Exelixis Clinical Site #185

Lübeck, Schleswig-Holstein, 23538, Germany

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Exelixis Clinical Site #227

Berlin, 10117, Germany

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Exelixis Clinical Site #239

Hamburg, 20246, Germany

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Exelixis Clinical Site #273

Hanover, 30625, Germany

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Exelixis Clinical Site #136

Tübingen, 72076, Germany

Location

Exelixis Clinical Site #238

Athens, Attica, 11526, Greece

Location

Exelixis Clinical Site #93

Cholargós, Attica, 15562, Greece

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Exelixis Clinical Site #202

Marousi, Attica, 15123, Greece

Location

Exelixis Clinical Site #92

Marousi, Attica, 15125, Greece

Location

Exelixis Clinical Site #244

Nea Kifissia, Attica, 14564, Greece

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Exelixis Clinical Site #99

Neo Faliro, Attica, 18547, Greece

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Exelixis Clinical Site #45

Heraklion, Crete, 71110, Greece

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Exelixis Clinical Site #64

Thessaloniki, Macedonia, 54007, Greece

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Exelixis Clinical Site #97

Larissa, Thessaly, 41110, Greece

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Exelixis Clinical Site #118

Budapest, 1062, Hungary

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Exelixis Clinical Site #207

Budapest, 1082, Hungary

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Exelixis Clinical Site #57

Budapest, 1122, Hungary

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Exelixis Clinical Site #109

Budapest, 1145, Hungary

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Exelixis Clinical Site #240

Debrecen, 4032, Hungary

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Exelixis site #167

Gyula, 5700, Hungary

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Exelixis Clinical Site #55

Haifa, 3109601, Israel

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Exelixis Clinical Site #27

Jerusalem, 9112001, Israel

Location

Exelixis Clinical Site #150

Petah Tikva, 4941492, Israel

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Exelixis Clinical Site #117

Ramat Gan, 5265601, Israel

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Exelixis Clinical Site #30

Safed, 1311001, Israel

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Exelixis Clinical Site #35

Tel Aviv, 6423906, Israel

Location

Exelixis Site #168

Meldola, FC, 47014, Italy

Location

Exelixis Clinical Site #246

Rozzano, Milano, 20089, Italy

Location

Exelixis Site #156

Sondrio, SO, 23100, Italy

Location

Exelixis Clinical Site #199

Trento, Trentino-Alto Adige, 38122, Italy

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Exelixis Clinical Site #217

Ancona, 60126, Italy

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Exelixis Clinical Site #121

Florence, 50134, Italy

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Exelixis Clinical Site #192

Milan, 20132, Italy

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Exelixis Clinical Site #258

Milan, 20133, Italy

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Exelixis Clinical #267

Parma, 43126, Italy

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Exelixis Clinical Site #237

Pavia, 27100, Italy

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Exelixis Clinical Site #107

Perugia, 06132, Italy

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Exelixis Clinical #269

Pisa, 56126, Italy

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Exelixis Clinical Site #62

Roma, 00144, Italy

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Exelixis Clinical Site #234

Roma, 00168, Italy

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Exelixis Clinical Site #96

Terni, 05100, Italy

Location

Exelixis Clinical Site #232

Toyota-shi, Aichi-ken, 471-8513, Japan

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Exelixis Clinical Site #100

Akita, Akita, 010-8543, Japan

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Exelixis Clinical Site #104

Hirosaki, Aomori, 036-8563, Japan

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Exelixis Clinical Site #43

Kashiwa-shi, Chiba, 277-8577, Japan

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Exelixis Clinical Site #54

Sakura-shi, Chiba, 285-8741, Japan

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Exelixis Clinical Site #72

Sapporo, Hokkaido, 060-8543, Japan

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Exelixis Clinical Site #37

Sapporo, Hokkaido, 060-8648, Japan

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Exelixis Clinical Site #70

Kobe, Hyōgo, 650-0017, Japan

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Exelixis Clinical Site #52

Kobe, Hyōgo, 650-0047, Japan

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Exelixis Clinical Site #84

Kita-gun, Kagawa-ken, 761-0793, Japan

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Exelixis Clinical Site #68

Sagamihara, Kanagawa, 252-0375, Japan

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Exelixis Clinical Site #22

Yokohama, Kanagawa, 232-0024, Japan

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Exelixis Clinical Site #211

Natori-shi, Miyagi, 981-1293, Japan

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Exelixis Clinical Site #88

Chūōku, Osaka-shi, 541-8567, Japan

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Exelixis Clinical Site #51

Hidaka, Saitama, 350-1298, Japan

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Exelixis Clinical Site #216

Shizuoka, Shizuoka, 420-8527, Japan

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Exelixis Clinical Site #65

Shinjuku-Ku, Tokyo, 160-8582, Japan

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Exelixis Clinical Site #61

Ube, Yamaguchi, 755-8505, Japan

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Exelixis Clinical Site #78

Chiba, 260-8717, Japan

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Exelixis Clinical Site #209

Fukuoka, 815-8588, Japan

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Exelixis Clinical Site #26

Nagano, 381-8551, Japan

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Exelixis Clinical Site #81

Ōsaka-sayama, 589-8511, Japan

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Exelixis Clinical Site #75

Tokyo, 135-8550, Japan

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Exelixis Clinical Site #32

Wakayama, 641-8510, Japan

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Exelixis Clinical Site #206

Tuxtla Gutiérrez, Chiapas, 29038, Mexico

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Exelixis Clinical Site #254

León, Guanajuato, 37178, Mexico

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Exelixis Clinical Site #212

Guadalajara, Jalisco, 44500, Mexico

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Exelixis Clinical Site #173

Guadalajara, Jalisco, 44600, Mexico

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Exelixis Clinical Site #219

Zapopan, Jalisco, 45040, Mexico

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Exelixis Clinical Site #187

Mexico City, Mexico City, 06760, Mexico

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Exelixis Clinical Site #257

Monterrey, Nuevo León, 64710, Mexico

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Exelixis Clinical Site #172

Querétaro City, Querétaro, 76070, Mexico

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Exelixis Clinical Site #182

Querétaro City, Querétaro, 76230, Mexico

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Exelixis Clinical Site #250

San Luis Potosí City, San Luis Potosí, 78200, Mexico

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Exelixis Clinical Site #184

San Luis Potosí City, San Luis Potosí, 78209, Mexico

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Exelixis Clinical Site #208

Culiacán, Sinaloa, C.P. 80020, Mexico

Location

Exelixis Clinical Site #174

Mexico City, 01120, Mexico

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Exelixis Clinical Site #272

Puebla City, 72530, Mexico

Location

Exelixis Clinical Site #243

Otwock, Masovian Voivodeship, 05-400, Poland

Location

Exelixis Clinical Site #82

Bydgoszcz, 85-796, Poland

Location

Exelixis Clinical #268

Lodz, 93-513, Poland

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Exelixis Clinical Site #89

Poznan, 60-569, Poland

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Exelixis Clinical Site #110

Braga, 4710-243, Portugal

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Exelixis Clinical Site #188

Guimarães, 4835-044, Portugal

Location

Exelixis Site #164

Lisbon, 1400-038, Portugal

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Exelixis Clinical Site #197

Lisbon, 1500-650, Portugal

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Exelixis Clinical Site #196

Loures, 2674-514, Portugal

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Exelixis Clinical Site #56

Porto, 4099-001, Portugal

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Exelixis Clinical Site #223

Porto, 4200-072, Portugal

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Exelixis Clinical Site #193

Vila Real, 5000-508, Portugal

Location

Exelixis Site #166

Moscow, 115478, Russia

Location

Exelixis Clinical Site #137

Saint Petersburg, 197022, Russia

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Exelixis Clinical Site #195

Saint Petersburg, 197758, Russia

Location

Exelixis Clinical Site #50

Singapore, 169610, Singapore

Location

Exelixis Clinical Site #87

Singapore, 258499, Singapore

Location

Exelixis Clinical Site #181

Singapore, 329563, Singapore

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Exelixis Clinical Site #20

Junggu, Daejeon, 35015, South Korea

Location

Exelixis Clinical Site #49

Goyang-si, Gyeonggi-do, 10408, South Korea

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Exelixis Clinical Site #60

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Exelixis Clinical Site #34

Hwasun, Jeollanam-do, 58128, South Korea

Location

Exelixis Clinical Site #58

Busan, 47392, South Korea

Location

Exelixis Clinical Site #24

Busan, 49241, South Korea

Location

Exelixis Clinical Site #94

Daegu, 41404, South Korea

Location

Exelixis Clinical Site #21

Daegu, 42601, South Korea

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Exelixis Clinical Site #40

Gwangju, 61469, South Korea

Location

Exelixis Clinical Site #59

Seoul, 03080, South Korea

Location

Exelixis Clinical Site #46

Seoul, 03722, South Korea

Location

Exelixis Clinical Site #25

Seoul, 06273, South Korea

Location

Exelixis Clinical Site #48

Seoul, 06351, South Korea

Location

Exelixis Clinical Site #229

Elche, Alicante, 03203, Spain

Location

Exelixis Clinical Site #220

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Exelixis Clinical Site #12

Manresa, Barcelona, 08243, Spain

Location

Exelixis Clinical Site #233

Santiago de Compostela, La Coruna, 15706, Spain

Location

Exelixis Clinical Site #17

Alcorcón, Madrid, 28922, Spain

Location

Exelixis Clinical Site #225

Oviedo, Principality of Asturias, 33011, Spain

Location

Exelixis Clinical Site #274

Badalona, 08916, Spain

Location

Exelixis Clinical Site #228

Barcelona, 08003, Spain

Location

Exelixis Clinical Site #23

Barcelona, 08035, Spain

Location

Exelixis Clinical Site #255

Barcelona, 08036, Spain

Location

Exelixis Clinical Site #190

Barcelona, 08041, Spain

Location

Exelixis Clinical Site #226

Cadiz, 11407, Spain

Location

Exelixis Clinical Site #33

Córdoba, 14004, Spain

Location

Exelixis Clinical Site #28

Lugo, 27003, Spain

Location

Exelixis Clinical Site #131

Madrid, 28033, Spain

Location

Exelixis Clinical Site #248

Madrid, 28040, Spain

Location

Exelixis Clinical Site #236

Madrid, 28041, Spain

Location

Exelixis Clinical Site #251

Madrid, 28046, Spain

Location

Exelixis Clinical Site #13

Madrid, 28050, Spain

Location

Exelixis Clinical #270

Málaga, 29010, Spain

Location

Exelixis Clinical Site #29

Seville, 41009, Spain

Location

Exelixis Clinical #266

Kaohsiung City, 81362, Taiwan

Location

Exelixis Clinical Site #138

Kaohsiung City, 833, Taiwan

Location

Exelixis Clinical Site #86

Taichung, 404, Taiwan

Location

Exelixis Clinical Site #133

Taichung, 407, Taiwan

Location

Exelixis Clinical Site #111

Tainan, 704, Taiwan

Location

Exelixis Clinical Site #271

Tainan, 710, Taiwan

Location

Exelixis Clinical #264

Taipei, 11217, Taiwan

Location

Exelixis Clinical #265

Taoyuan District, 333, Taiwan

Location

Exelixis Clinical Site #102

Dnipro, 49005, Ukraine

Location

Exelixis Clinical Site #186

Dnipro, 49102, Ukraine

Location

Exelixis Clinical Site #76

Kyiv, 02125, Ukraine

Location

Exelixis Clinical Site #71

Lutsk, 43018, Ukraine

Location

Exelixis Clinical Site #205

London, England, SE1 9RT, United Kingdom

Location

Exelixis Clinical Site #235

Surrey Quays, England, SM2 5PT, United Kingdom

Location

Exelixis Clinical Site #241

Taunton, England, TA1 5DA, United Kingdom

Location

Exelixis Clinical Site #249

Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

Exelixis Clinical Site #231

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Exelixis Clinical Site #194

Swansea, Wales, SA2 Q8A, United Kingdom

Location

Related Publications (2)

• Agarwal N, Azad AA, Carles J, Matsubara N, Oudard S, Saad F, Merseburger AS, Soares A, McGregor BA, Zurawski B, Tsiatas M, North S, Bondarenko I, Alfie M, Bournakis E, Antonuzzo L, Evilevitch L, Simmons A, Wang F, Ferraldeschi R, Nandoskar P, Pal SK. Cabozantinib plus atezolizumab in metastatic prostate cancer (CONTACT-02): final analyses from a phase 3, open-label, randomised trial. Lancet Oncol. 2025 Jul;26(7):860-876. doi: 10.1016/S1470-2045(25)00209-8. Epub 2025 Jun 13.

  PMID: 40523369 DERIVED

• Agarwal N, Azad A, Carles J, Chowdhury S, McGregor B, Merseburger AS, Oudard S, Saad F, Soares A, Benzaghou F, Kerloeguen Y, Kimura A, Mohamed N, Panneerselvam A, Wang F, Pal S. A phase III, randomized, open-label study (CONTACT-02) of cabozantinib plus atezolizumab versus second novel hormone therapy in patients with metastatic castration-resistant prostate cancer. Future Oncol. 2022 Mar;18(10):1185-1198. doi: 10.2217/fon-2021-1096. Epub 2022 Jan 17.

  PMID: 35034502 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabozantinib; atezolizumab; Abiraterone Acetate; abiraterone; enzalutamide; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes

Results Point of Contact

• Title: Exelixis Medical Information
• Organization: Exelixis, Inc.

druginfo@exelixis.com

855-292-3935

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: October 19, 2020
• Primary Completion: April 19, 2024
• Study Completion (Estimated): October 16, 2026
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (24); DE (9); GE (6); BE (4); SG (3); PT (8); RU (3); IT (15); GR (9); ES (21); AU (3); TW (8); UA (4); GB (6); CL (8); AR (13); CA (8); PL (4); BR (14); FR (15); ME (14); KR (13); CZ (6); US (36); HU (6); IL (6)