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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04446117
Registration number
NCT04446117
Ethics application status
Date submitted
22/06/2020
Date registered
24/06/2020
Titles & IDs
Public title
Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
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Scientific 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
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Secondary ID [1]
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XL184-315
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Universal Trial Number (UTN)
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Trial acronym
CONTACT-02
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer
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Prostate Adenocarcinoma
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cabozantinib
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Abiraterone Acetate
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Prednisone
Experimental: Experimental Arm - Subjects with mCRPC will receive cabozantinib 40mg oral, qd + atezolizumab 1200mg infusion, q3w
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
Treatment: Drugs: Cabozantinib
Supplied as 20-mg tablets; administered orally daily at 40mg
Treatment: Drugs: Atezolizumab
Supplied as 1200 mg/20 mL vials; administered as an IV infusion once every 3 weeks (q3w)
Treatment: Drugs: Abiraterone Acetate
Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid
Treatment: Drugs: Enzalutamide
Supplied as 40 mg capsules; administered orally daily at 160mg
Treatment: Drugs: Prednisone
Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Duration of Progression Free Survival per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1)
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Assessment method [1]
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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
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Timepoint [1]
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Approximately 21 months after the first subject is randomized.
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Primary outcome [2]
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Duration of Overall Survival (OS)
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Assessment method [2]
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Defined as time from randomization to date of death from any cause
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Timepoint [2]
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Approximately 37 months after the first subject is randomized
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Secondary outcome [1]
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Objective response rate (ORR)
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Assessment method [1]
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ORR per RECIST 1.1 by BIRC
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Timepoint [1]
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Approximately 37 months after the first subject is randomized
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
575
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC
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Recruitment hospital [1]
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Exelixis Clinical Site #151 - Garran
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Exelixis Clinical Site #252 - Port Macquarie
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Exelixis Clinical Site #175 - Saint Leonards
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Exelixis Clinical #262 - Geelong
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Exelixis Clinical Site #53 - Melbourne
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Exelixis Clinical Stie #260 - Saint Albans
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Exelixis Clinical Site #115 - Adelaide
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Exelixis Clinical Site #149 - Box Hill
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2605 - Garran
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2444 - Port Macquarie
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2065 - Saint Leonards
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2109 - Sydney
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2500 - Wollongong
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4032 - Chermside
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7250 - Launceston
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3350 - Ballarat
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3199 - Frankston
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3220 - Geelong
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3000 - Melbourne
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3021 - Saint Albans
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5000 - Adelaide
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Recruitment postcode(s) [14]
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3128 - Box Hill
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Recruitment outside Australia
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Italy
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State/province [111]
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Parma
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Italy
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Pavia
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Italy
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Perugia
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Italy
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Pisa
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Italy
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Roma
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Italy
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Terni
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Japan
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Aichi
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Japan
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Akita
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Japan
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Aomori
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Japan
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Chiba
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kagawa
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Osaka-shi
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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State/province [129]
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Tokyo
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Japan
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Yamaguchi
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Japan
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Fukuoka
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Japan
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Nagano
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Japan
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State/province [133]
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Wakayama
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Japan
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Osaka-sayama
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeonggi-Do
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
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Busan
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Korea, Republic of
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State/province [140]
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Daegu
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Korea, Republic of
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State/province [141]
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Gwangju
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Korea, Republic of
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Seoul
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Mexico
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Chiapas
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Mexico
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Distrito Federal
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Mexico
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Guanajuato
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Mexico
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Queretaro
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Mexico
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San Luis Potosi
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Mexico
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Sinaloa
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Mexico
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Mexico City
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Mexico
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Puebla
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Poland
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Mazowieckie
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Poland
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Bydgoszcz
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Poland
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Poznan
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Poland
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Lódz
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Portugal
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Braga
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Portugal
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Guimarães
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Portugal
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Lisboa
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Portugal
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Loures
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Portugal
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Porto
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Portugal
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Vila Real
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Singapore
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Singapore
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Spain
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Alicante
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Islas Baleares
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Spain
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La Coruna
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Spain
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Madrid
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Spain
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Badalona
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Spain
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Cadiz
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Spain
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Córdoba
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Spain
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Lugo
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Spain
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Málaga
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Country [177]
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Spain
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Sevilla
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Taiwan
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Kaohsiung
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Taiwan
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Taichung City
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Taiwan
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Taichung
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Taiwan
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Tainan City
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Taiwan
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Tainan
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Taiwan
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Taipei city
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Taiwan
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Taoyuan
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Ukraine
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Dnipro
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Ukraine
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Kyiv
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Ukraine
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Luts'k
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United Kingdom
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England
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United Kingdom
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Lancashire
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United Kingdom
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Middlesex
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United Kingdom
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State/province [191]
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Wales
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Exelixis
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Address
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Country
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Other collaborator category [1]
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0
Commercial sector/industry
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Name [1]
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Roche-Genentech
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Address [1]
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0
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Other collaborator category [2]
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Commercial sector/industry
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Takeda
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0
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04446117
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04446117