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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
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
Secondary ID [1] 0 0
XL184-315
Universal Trial Number (UTN)
Trial acronym
CONTACT-02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 0 0
Prostate Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of Progression Free Survival per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Timepoint [1] 0 0
Approximately 21 months after the first subject is randomized.
Primary outcome [2] 0 0
Duration of Overall Survival (OS)
Timepoint [2] 0 0
Approximately 37 months after the first subject is randomized
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Approximately 37 months after the first subject is randomized

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/10/2026
Actual
Sample size
Target
Accrual to date
Final
575
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Exelixis Clinical Site #151 - Garran
Recruitment hospital [2] 0 0
Exelixis Clinical Site #252 - Port Macquarie
Recruitment hospital [3] 0 0
Exelixis Clinical Site #175 - Saint Leonards
Recruitment hospital [4] 0 0
Exelixis Clinical Site # 189 - Sydney
Recruitment hospital [5] 0 0
Exelixis Site #162 - Wollongong
Recruitment hospital [6] 0 0
Exelixis Clinical Site #253 - Chermside
Recruitment hospital [7] 0 0
Exelixis Clinical Site #103 - Launceston
Recruitment hospital [8] 0 0
Exelixis Clinical Site #79 - Ballarat
Recruitment hospital [9] 0 0
Exelixis Clinical Site #95 - Frankston
Recruitment hospital [10] 0 0
Exelixis Clinical #262 - Geelong
Recruitment hospital [11] 0 0
Exelixis Clinical Site #53 - Melbourne
Recruitment hospital [12] 0 0
Exelixis Clinical Stie #260 - Saint Albans
Recruitment hospital [13] 0 0
Exelixis Clinical Site #115 - Adelaide
Recruitment hospital [14] 0 0
Exelixis Clinical Site #149 - Box Hill
Recruitment postcode(s) [1] 0 0
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
Recruitment postcode(s) [13] 0 0
5000 - Adelaide
Recruitment postcode(s) [14] 0 0
3128 - Box Hill
Recruitment outside Australia
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Tainan
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Taipei city
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Taoyuan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Exelixis
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Roche-Genentech
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
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Takeda
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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Public notes

Contacts
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Address 0 0
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Phone 0 0
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Email 0 0
Contact person for public queries
Name 0 0
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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