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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04338269




Registration number
NCT04338269
Ethics application status
Date submitted
6/04/2020
Date registered
8/04/2020

Titles & IDs
Public title
A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment
Scientific title
A Phase III, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination With Cabozantinib Versus Cabozantinib Alone in Patients With Inoperable, Locally Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment
Secondary ID [1] 0 0
WO41994
Universal Trial Number (UTN)
Trial acronym
CONTACT-03
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Cabozantinib

Experimental: Atezo+Cabo - Participants will receive atezolizumab every 3 weeks on Day 1 of each 21-day cycle (1 cycle=21 days) plus oral tablets of cabozantinib every day.

Active comparator: Cabozantinib - Participants will receive cabozantinib every day.


Treatment: Drugs: Atezolizumab
Atezolizumab 1200 mg will be administered at a fixed dose on Day 1 of each 21-day cycle by IV infusion every 3 weeks.

Treatment: Drugs: Cabozantinib
Cabozantinib 60 mg (three 20-mg tablets) administered orally once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) as Assessed by an Independent Review Facility (IRF) (IRF-PFS) According to RECIST v1.1
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression according to RECIST v1.1 (up to 2 years 5 months).
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From randomization to death due to any cause (up to 2 years 5 months).
Secondary outcome [1] 0 0
Progression Free Survival (PFS) as Assessed by Investigators (INV-PFS), According to RECIST v1.1
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).
Secondary outcome [2] 0 0
Investigator-assessed Overall Response Rate (ORR) (INV-ORR) According to RECIST v1.1
Timepoint [2] 0 0
From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).
Secondary outcome [3] 0 0
Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1
Timepoint [3] 0 0
From randomization to the first occurrence of disease progression according to RECIST v1.1 or death from any cause (whichever occurs first) (up to 2 years 5 months).
Secondary outcome [4] 0 0
Investigator-assessed Duration of Response (DOR) (INV-DOR) According to RECIST v1.1
Timepoint [4] 0 0
From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 2 years 5 months)
Secondary outcome [5] 0 0
Independent Review Facility (IRF)-Assessed Duration of Response (DOR) (IRF-DOR) According to RECIST v1.1
Timepoint [5] 0 0
From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 2 years 5 months)

Eligibility
Key inclusion criteria
* Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary, chromophobe, and unclassified only) RCC. RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation.
* Radiographic disease progression to prior ICI therapy for RCC. Patients who experienced radiographic tumor progression during or within 6 months after the last dose of adjuvant ICI are also eligible. ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, durvalumab, or nivolumab. Only patients for whom the immediate preceding line of therapy was an ICI are allowed.
* Measurable disease per RECIST v1.1
* Evaluable IMDC risk score
* Archival tumor specimen, and pretreatment tumor tissue from fresh biopsy at screening, if clinically feasible. Both archival and fresh samples are preferred.
* KPS score of >=70
* Recovery to baseline or Grade </= 1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable in the opinion of the investigator. Grade 2 alopecia is allowed for study participation
* Adequate hematologic and end-organ function
* Negative HIV test at screening
* Negative hepatitis B testing at screening
* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Treatment with anti-cancer therapy within 14 days prior to initiation of study treatment
* Patients received cabozantinib at any time prior to screening
* Patients who received more than one ICI treatment in the locally advanced or metastatic setting
* Patients who received more than two prior lines of therapy in the locally advanced or metastatic setting
* Patients who have received a mammalian target of rapamycin (mTOR) inhibitor in any setting
* Symptomatic, untreated, or actively progressing CNS metastases
* History of leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
* History of malignancy other than renal carcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Radiotherapy for RCC within 14 days prior to Day 1 of Cycle 1
* Active tuberculosis
* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after final dose of atezolizumab and 4 months after final dose of cabozantinib
* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety
* Pharmacologically uncompensated, symptomatic hypothyroidism
* Uncontrolled hypertension defined as sustained blood pressure >150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment (all countries except France); sustained BP > 140 mmHg systolic or > 90 mmHg diastolic despite optimal antihypertensive treatment (France only)
* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, unstable arrhythmia, or unstable angina) within 3 months prior to initiation of study treatment
* Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1
* History of congenital QT syndrome
* History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g. clopidogrel)

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
28/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
Accrual to date
Final
522
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 0 0
Orange Hospital - Orange
Recruitment hospital [3] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [4] 0 0
Bendigo Cancer Centre - Bendigo
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [2] 0 0
2800 - Orange
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
3550 - Bendigo
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Ciudad Autonoma Bs As
Country [19] 0 0
Argentina
State/province [19] 0 0
Ciudad Autonoma Buenos Aires
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Denmark
State/province [21] 0 0
Herlev
Country [22] 0 0
France
State/province [22] 0 0
Besançon Cedex
Country [23] 0 0
France
State/province [23] 0 0
Bordeaux
Country [24] 0 0
France
State/province [24] 0 0
Caen
Country [25] 0 0
France
State/province [25] 0 0
Clermont Ferrand
Country [26] 0 0
France
State/province [26] 0 0
Lille
Country [27] 0 0
France
State/province [27] 0 0
Lyon
Country [28] 0 0
France
State/province [28] 0 0
Nice
Country [29] 0 0
France
State/province [29] 0 0
Nimes
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Strasbourg
Country [32] 0 0
France
State/province [32] 0 0
Villejuif
Country [33] 0 0
Germany
State/province [33] 0 0
Chemnitz
Country [34] 0 0
Germany
State/province [34] 0 0
Frankfurt
Country [35] 0 0
Germany
State/province [35] 0 0
Freiburg
Country [36] 0 0
Germany
State/province [36] 0 0
Halle (Saale)
Country [37] 0 0
Germany
State/province [37] 0 0
Hamburg
Country [38] 0 0
Germany
State/province [38] 0 0
Hannover
Country [39] 0 0
Germany
State/province [39] 0 0
Muenster
Country [40] 0 0
Germany
State/province [40] 0 0
München
Country [41] 0 0
Germany
State/province [41] 0 0
Tübingen
Country [42] 0 0
Germany
State/province [42] 0 0
Ulm
Country [43] 0 0
Greece
State/province [43] 0 0
Athens
Country [44] 0 0
Greece
State/province [44] 0 0
Chaidari
Country [45] 0 0
Greece
State/province [45] 0 0
Larissa
Country [46] 0 0
Greece
State/province [46] 0 0
Thessaloniki
Country [47] 0 0
Italy
State/province [47] 0 0
Campania
Country [48] 0 0
Italy
State/province [48] 0 0
Emilia-Romagna
Country [49] 0 0
Italy
State/province [49] 0 0
Lazio
Country [50] 0 0
Italy
State/province [50] 0 0
Lombardia
Country [51] 0 0
Italy
State/province [51] 0 0
Marche
Country [52] 0 0
Italy
State/province [52] 0 0
Piemonte
Country [53] 0 0
Italy
State/province [53] 0 0
Puglia
Country [54] 0 0
Italy
State/province [54] 0 0
Umbria
Country [55] 0 0
Italy
State/province [55] 0 0
Veneto
Country [56] 0 0
Japan
State/province [56] 0 0
Hokkaido
Country [57] 0 0
Japan
State/province [57] 0 0
Ibaraki
Country [58] 0 0
Japan
State/province [58] 0 0
Kanagawa
Country [59] 0 0
Japan
State/province [59] 0 0
Okayama
Country [60] 0 0
Japan
State/province [60] 0 0
Osaka
Country [61] 0 0
Japan
State/province [61] 0 0
Tokushima
Country [62] 0 0
Japan
State/province [62] 0 0
Tokyo
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Daejeon
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Gyeonggi-do
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Gyeongsangnam-do
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Jeollanam-do
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Seongnam-si
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Seoul
Country [69] 0 0
Poland
State/province [69] 0 0
?ód?
Country [70] 0 0
Poland
State/province [70] 0 0
Brzozów
Country [71] 0 0
Poland
State/province [71] 0 0
Bydgoszcz
Country [72] 0 0
Poland
State/province [72] 0 0
Bytom
Country [73] 0 0
Poland
State/province [73] 0 0
Otwock
Country [74] 0 0
Poland
State/province [74] 0 0
Pozna?
Country [75] 0 0
Poland
State/province [75] 0 0
Warszawa
Country [76] 0 0
Poland
State/province [76] 0 0
Wroc?aw
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Jaroslavl
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Leningrad
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Moskovskaja Oblast
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Sankt Petersburg
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Novosibirsk
Country [82] 0 0
Spain
State/province [82] 0 0
Asturias
Country [83] 0 0
Spain
State/province [83] 0 0
Barcelona
Country [84] 0 0
Spain
State/province [84] 0 0
Cantabria
Country [85] 0 0
Spain
State/province [85] 0 0
Cordoba
Country [86] 0 0
Spain
State/province [86] 0 0
Islas Baleares
Country [87] 0 0
Spain
State/province [87] 0 0
Pontevedra
Country [88] 0 0
Spain
State/province [88] 0 0
Burgos
Country [89] 0 0
Spain
State/province [89] 0 0
Caceres
Country [90] 0 0
Spain
State/province [90] 0 0
Lugo
Country [91] 0 0
Spain
State/province [91] 0 0
Madrid
Country [92] 0 0
Spain
State/province [92] 0 0
Malaga
Country [93] 0 0
Spain
State/province [93] 0 0
Murcia
Country [94] 0 0
Spain
State/province [94] 0 0
Navarra
Country [95] 0 0
Spain
State/province [95] 0 0
Sevilla
Country [96] 0 0
Spain
State/province [96] 0 0
Valencia
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Blackburn
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Leicester
Country [99] 0 0
United Kingdom
State/province [99] 0 0
London
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Manchester
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Exelixis
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Chugai
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04338269