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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03528694




Registration number
NCT03528694
Ethics application status
Date submitted
28/02/2018
Date registered
18/05/2018

Titles & IDs
Public title
Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer
Scientific title
A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer Patients
Secondary ID [1] 0 0
2017-002979-26
Secondary ID [2] 0 0
D419JC00001
Universal Trial Number (UTN)
Trial acronym
POTOMAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-muscle-invasive Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Durvalumab (MEDI4736)
Treatment: Other - Bacillus Calmette-Guerin (BCG)

Experimental: Durvalumab plus BCG (induction + maintenance) - Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy

Experimental: Durvalumab plus BCG (induction only) - Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy

Active comparator: BCG treatment (Standard of care therapy) - Bacillus Calmette-Guerrin (BCG) standard of care treatment


Treatment: Other: Durvalumab (MEDI4736)
Investigational product

Treatment: Other: Bacillus Calmette-Guerin (BCG)
Standard of care
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The efficacy of Durvalumab + BCG (induction plus maintenance) combination therapy compared to SoC in terms of Disease free survival (DFS) in patients with NMIBC
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [1] 0 0
The efficacy of Durvalumab + BCG (induction plus maintenance) therapy compare to SoC in terms of DFS after 24 months of last subject's last dose of IP
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Disease-related symptoms and HRQoL in patients with NMIBC treated with Durvalumab + BCG combination therapies compared to SoC and compared to each other using the EORTC QLQ-C30 questionnaire
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Patient-reported treatment tolerability using specific PRO CTCAE symptoms
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
The serum concentration of Durvalumab plus BCG combination therapies
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
The immunogenicity of Durvalumab when used in combination with BCG treatment assessed by descriptive summary of presence of ADAs
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
The efficacy of Durvalumab + BCG (induction plus maintenance) therapy compare to SoC in terms of OS
Timepoint [6] 0 0
Up to 7 years
Secondary outcome [7] 0 0
The efficacy of Durvalumab + BCG (induction plus maintenance) combination therapy compared to SoC in terms of time to muscle invasive bladder cancer and/or metastatic disease
Timepoint [7] 0 0
Up to 7 years
Secondary outcome [8] 0 0
The efficacy of Durvalumab + BCG (induction only) combination therapy compared to SoC in terms of DFS after 24 months of last subject's last dose of IP
Timepoint [8] 0 0
Up to 4 years
Secondary outcome [9] 0 0
The efficacy of Durvalumab + BCG combination therapies compared to each other in terms of DFS after 24 months of last subject's last dose of IP
Timepoint [9] 0 0
Up to 4 years
Secondary outcome [10] 0 0
The efficacy of Durvalumab + BCG (induction only) combination therapy compared to SoC in terms of OS
Timepoint [10] 0 0
Up to 7 years
Secondary outcome [11] 0 0
The efficacy of Durvalumab + BCG combination therapies compared to each other in terms of OS
Timepoint [11] 0 0
Up to 7 years
Secondary outcome [12] 0 0
The efficacy of Durvalumab + BCG (induction only) combination therapy compared to SoC in terms of time to muscle invasive bladder cancer and/or metastatic disease
Timepoint [12] 0 0
Up to 7 years
Secondary outcome [13] 0 0
The efficacy of Durvalumab + BCG combination therapies compared to each other in terms of time to muscle invasive bladder cancer and/or metastatic disease
Timepoint [13] 0 0
Up to 7 years
Secondary outcome [14] 0 0
Disease-related symptoms and HRQoL in patients with NMIBC treated with Durvalumab + BCG combination therapies compared to SoC and compared to each other using the the EORTC QLQ NMIBC24 questionnaire
Timepoint [14] 0 0
Up to 4 years
Secondary outcome [15] 0 0
The efficacy of durvalumab + BCG combination therapy compared to SoC in terms of CRR for patients with CIS prior to study entry or at baseline cystoscopy
Timepoint [15] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
For inclusion in the study, patients should fulfill the following criteria:

* Aged at least 18 years
* BCG-naïve (patients who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry are eligible)
* Local histological confirmation (based on pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high risk tumor is defined as one of the following

* T1 tumor
* High grade/ G3 tumor
* CIS
* Multiple and recurrent and large (with diameter of largest tumor =3 cm) tumors (all conditions must be met in this point)
* Complete resection of all Ta/T1 papillary disease prior to randomization, with the TURBT removing high-risk NMIBC performed not more than 4 months before randomization in the study. Patients with residual CIS after TURBT are eligible
* No prior radiotherapy for bladder cancer
* No prior exposure to immune-mediated therapy of cancer including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 antibodies. Patients who have been treated with anticancer vaccines will be excluded
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients should not enter the study if any of the following exclusion criteria are fulfilled:

* Evidence of muscle-invasive, locally advanced, metastatic, and/or extra vesical bladder cancer (ie, T2, T3, T4, and / or stage IV)
* Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive transitional cell carcinoma of the urothelium
* Previous investigational product (IP) assignment in the present study
* Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer related conditions (eg, hormone replacement therapy) is acceptable. Chemotherapy for previous instances of NMIBC is acceptable.
* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:

* Patients with vitiligo or alopecia
* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
* Any chronic skin condition that does not require systemic therapy
* Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician
* Patients with celiac disease controlled by diet alone
* History of another primary malignancy except for

* Malignancy treated with curative intent and with no known active disease = 2 years before the first dose of IP and of low potential risk for recurrence during the study period
* Adequately treated nonmelanoma skin cancer or lentigo maligna withoutevidence of disease
* Adequately treated CIS without evidence of disease
* Prostate cancer (tumor/node/metastasis stage) of stage = T2cN0M0 without biochemical recurrence or progression that in the opinion of the Investigator does not require active intervention
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:

* Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection)
* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
* Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication)

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
14/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
Accrual to date
Final
1018
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Auchenflower
Recruitment hospital [2] 0 0
Research Site - Box Hill
Recruitment hospital [3] 0 0
Research Site - Brisbane
Recruitment hospital [4] 0 0
Research Site - Kogarah
Recruitment hospital [5] 0 0
Research Site - Orange
Recruitment hospital [6] 0 0
Research Site - Parkville
Recruitment hospital [7] 0 0
Research Site - Westmead
Recruitment hospital [8] 0 0
Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
4122 - Brisbane
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2800 - Orange
Recruitment postcode(s) [6] 0 0
3000 - Parkville
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Austria
State/province [4] 0 0
Salzburg
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Belgium
State/province [6] 0 0
Brussels
Country [7] 0 0
Belgium
State/province [7] 0 0
Gent
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Roeselare
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
France
State/province [12] 0 0
Amiens
Country [13] 0 0
France
State/province [13] 0 0
Angers Cedex 01
Country [14] 0 0
France
State/province [14] 0 0
Bordeaux Cedex
Country [15] 0 0
France
State/province [15] 0 0
LYON cedex 03
Country [16] 0 0
France
State/province [16] 0 0
Marseille
Country [17] 0 0
France
State/province [17] 0 0
Montpellier CEDEX 5
Country [18] 0 0
France
State/province [18] 0 0
Strasbourg Cedex
Country [19] 0 0
France
State/province [19] 0 0
Suresnes Cedex
Country [20] 0 0
Germany
State/province [20] 0 0
Berlin
Country [21] 0 0
Germany
State/province [21] 0 0
Duisburg
Country [22] 0 0
Germany
State/province [22] 0 0
Hannover
Country [23] 0 0
Germany
State/province [23] 0 0
Heidelberg
Country [24] 0 0
Germany
State/province [24] 0 0
Köln
Country [25] 0 0
Germany
State/province [25] 0 0
Marburg
Country [26] 0 0
Germany
State/province [26] 0 0
Mettmann
Country [27] 0 0
Germany
State/province [27] 0 0
Mühlheim An Der Ruhr
Country [28] 0 0
Germany
State/province [28] 0 0
München
Country [29] 0 0
Germany
State/province [29] 0 0
Münster
Country [30] 0 0
Germany
State/province [30] 0 0
Nürtingen
Country [31] 0 0
Germany
State/province [31] 0 0
Wesel
Country [32] 0 0
Germany
State/province [32] 0 0
Würselen
Country [33] 0 0
Germany
State/province [33] 0 0
Zirndorf
Country [34] 0 0
Japan
State/province [34] 0 0
Bunkyo-ku
Country [35] 0 0
Japan
State/province [35] 0 0
Fukuoka
Country [36] 0 0
Japan
State/province [36] 0 0
Hirosaki-shi
Country [37] 0 0
Japan
State/province [37] 0 0
Kanazawa-shi
Country [38] 0 0
Japan
State/province [38] 0 0
Kita-gun
Country [39] 0 0
Japan
State/province [39] 0 0
Koshigaya-shi
Country [40] 0 0
Japan
State/province [40] 0 0
Koto-ku
Country [41] 0 0
Japan
State/province [41] 0 0
Matsuyama-shi
Country [42] 0 0
Japan
State/province [42] 0 0
Miyazaki-city
Country [43] 0 0
Japan
State/province [43] 0 0
Nagasaki-shi
Country [44] 0 0
Japan
State/province [44] 0 0
Nagoya-shi
Country [45] 0 0
Japan
State/province [45] 0 0
Okayama-shi
Country [46] 0 0
Japan
State/province [46] 0 0
Osaka-shi
Country [47] 0 0
Japan
State/province [47] 0 0
Osakasayama-shi
Country [48] 0 0
Japan
State/province [48] 0 0
Sapporo-shi
Country [49] 0 0
Japan
State/province [49] 0 0
Shinjuku-ku
Country [50] 0 0
Japan
State/province [50] 0 0
Toyama-shi
Country [51] 0 0
Japan
State/province [51] 0 0
Tsukuba-shi
Country [52] 0 0
Japan
State/province [52] 0 0
Yokohama-shi
Country [53] 0 0
Netherlands
State/province [53] 0 0
Amsterdam
Country [54] 0 0
Netherlands
State/province [54] 0 0
Breda
Country [55] 0 0
Netherlands
State/province [55] 0 0
Utrecht
Country [56] 0 0
Poland
State/province [56] 0 0
Bialystok
Country [57] 0 0
Poland
State/province [57] 0 0
Gdansk
Country [58] 0 0
Poland
State/province [58] 0 0
Grudziadz
Country [59] 0 0
Poland
State/province [59] 0 0
Koszalin
Country [60] 0 0
Poland
State/province [60] 0 0
Piotrków Trybunalski
Country [61] 0 0
Poland
State/province [61] 0 0
Poznan
Country [62] 0 0
Poland
State/province [62] 0 0
Warszawa
Country [63] 0 0
Poland
State/province [63] 0 0
Wroclaw
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Ivanovo
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Krasnoyarsk
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Nizhniy Novgorod
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Obninsk
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Omsk
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Saint Petersburg
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Saint-Petersburg
Country [72] 0 0
Russian Federation
State/province [72] 0 0
St Petersburg
Country [73] 0 0
Russian Federation
State/province [73] 0 0
St. Petersburg
Country [74] 0 0
Russian Federation
State/province [74] 0 0
St.Petersburg
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Vologda
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Yaroslavl
Country [77] 0 0
Spain
State/province [77] 0 0
Badajoz
Country [78] 0 0
Spain
State/province [78] 0 0
Barcelona
Country [79] 0 0
Spain
State/province [79] 0 0
Elche(Alicante)
Country [80] 0 0
Spain
State/province [80] 0 0
Madrid
Country [81] 0 0
Spain
State/province [81] 0 0
Malaga
Country [82] 0 0
Spain
State/province [82] 0 0
Oviedo
Country [83] 0 0
Spain
State/province [83] 0 0
Pamplona
Country [84] 0 0
Spain
State/province [84] 0 0
Pozuelo de Alarcon
Country [85] 0 0
Spain
State/province [85] 0 0
Sevilla
Country [86] 0 0
Spain
State/province [86] 0 0
Valencia
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Birmingham
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Glasgow
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Guildford
Country [90] 0 0
United Kingdom
State/province [90] 0 0
London
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Sheffield
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Southampton
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Taunton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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 can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


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/NCT03528694