SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF 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

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


  • Org Study ID: D419JC00001
  • Secondary ID:
  • NCT ID: NCT03528694
  • NCT Alias:
  • Sponsor: AstraZeneca - Industry
  • Source: AstraZeneca

Brief Summary

This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer.

Detailed Description


Patients will be randomized in a 1:1:1 ratio to receive treatment with Durvalumab + BCG
combination therapies, or Standard of Care (SoC) therapy.

Overal Status Start Date Phase Study Type
Recruiting May 14, 2018 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: The efficacy of Durvalumab + BCG (induction plus maintenance) combination therapy compared to SoC in terms of Disease free survival (DFS) in patients with NMIBC

Primary Outcome 1 - Time Frame: Up to 4 years

Condition:

  • Non-muscle-invasive Bladder Cancer

Eligibility

Criteria:
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

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)
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Healthy Volunteers: No

Overall Contact

Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Locations

Facility Status Contact
Research Site
Auchenflower, 4066
Australia
Recruiting
Research Site
Box Hill, 3128
Australia
Recruiting
Research Site
Brisbane, 4122
Australia
Recruiting
Research Site
Kogarah, 2217
Australia
Recruiting
Research Site
Orange, 2800
Australia
Recruiting
Research Site
Parkville, 3000
Australia
Recruiting
Research Site
Westmead, 2145
Australia
Recruiting
Research Site
Wollongong, 2500
Australia
Recruiting
Research Site
Innsbruck, 6020
Austria
Recruiting
Research Site
Linz, 4020
Austria
Recruiting
Research Site
Wien, 1090
Austria
Recruiting
Research Site
Brussels, 1070
Belgium
Recruiting
Research Site
Gent, 9000
Belgium
Not yet recruiting
Research Site
Leuven, 3000
Belgium
Recruiting
Research Site
Roeselare, 8800
Belgium
Recruiting
Research Site
Burnaby, British Columbia V5G 2X6
Canada
Withdrawn
Research Site
Vancouver, British Columbia V5Z 1M9
Canada
Withdrawn
Research Site
Halifax, Nova Scotia B3H 2Y9
Canada
Withdrawn
Research Site
Hamilton, Ontario L8N 4A6
Canada
Recruiting
Research Site
Kingston, Ontario K7L 3J7
Canada
Recruiting
Research Site
Ottawa, Ontario K1H 8L6
Canada
Withdrawn
Research Site
Toronto, Ontario M4N 3M5
Canada
Withdrawn
Research Site
Toronto, Ontario M5G 2M9
Canada
Recruiting
Research Site
Chicoutimi, Quebec G7H 5H6
Canada
Recruiting
Research Site
Montreal, Quebec H2X 3E4
Canada
Recruiting
Research Site
Quebec, G1R 3S1
Canada
Recruiting
Research Site
Amiens, 80480
France
Recruiting
Research Site
Angers Cedex 01, 49033
France
Recruiting
Research Site
Bordeaux Cedex, 33076
France
Recruiting
Research Site
LYON cedex 03, 69437
France
Recruiting
Research Site
Marseille, 13003
France
Recruiting
Research Site
Montpellier CEDEX 5, 34295
France
Recruiting
Research Site
Strasbourg Cedex, 67091
France
Recruiting
Research Site
Suresnes, 92151
France
Recruiting
Research Site
Berlin, 12200
Germany
Recruiting
Research Site
Duisburg, 47179
Germany
Recruiting
Research Site
Hamburg, 22399
Germany
Withdrawn
Research Site
Hannover, 30625
Germany
Recruiting
Research Site
Heidelberg, 69120
Germany
Recruiting
Research Site
Heinsberg, 52525
Germany
Not yet recruiting
Research Site
Köln, 50968
Germany
Recruiting
Research Site
Marburg, 35043
Germany
Recruiting
Research Site
Mettmann, 40822
Germany
Recruiting
Research Site
Mühlheim An Der Ruhr, 45468
Germany
Recruiting
Research Site
München, 81377
Germany
Recruiting
Research Site
Münster, 48149
Germany
Recruiting
Research Site
Nürtingen, 72766
Germany
Recruiting
Research Site
Wesel,
Germany
Not yet recruiting
Research Site
Würselen, 52146
Germany
Not yet recruiting
Research Site
Zirndorf, 90513
Germany
Recruiting
Research Site
Bunkyo-ku, 113-8603
Japan
Recruiting
Research Site
Fukuoka, 812-8582
Japan
Recruiting
Research Site
Kanazawa-shi, 920-8641
Japan
Recruiting
Research Site
Kita-gun, 761-0793
Japan
Recruiting
Research Site
Koto-ku, 135-8550
Japan
Recruiting
Research Site
Matsuyama-shi, 791-0280
Japan
Recruiting
Research Site
Miyazaki-city, 889-1692
Japan
Recruiting
Research Site
Nagasaki-shi, 852-8501
Japan
Recruiting
Research Site
Nagoya-shi, 467-0001
Japan
Recruiting
Research Site
Okayama-shi, 700-8558
Japan
Recruiting
Research Site
Osaka-shi, 541-8567
Japan
Recruiting
Research Site
Osaka-shi, 545-8586
Japan
Recruiting
Research Site
Osakasayama-shi, 589-8511
Japan
Recruiting
Research Site
Sapporo-shi, 060-8543
Japan
Recruiting
Research Site
Shinjuku-ku, 160-8582
Japan
Recruiting
Research Site
Toyama-shi, 930-0194
Japan
Recruiting
Research Site
Tsukuba-shi, 305-8576
Japan
Recruiting
Research Site
Yokohama-shi, 232-0024
Japan
Recruiting
Research Site
Arnhem, 6815 AD
Netherlands
Withdrawn
Research Site
Brussels, 1090
Netherlands
Recruiting
Research Site
Leuven, 3000
Netherlands
Recruiting
Research Site
Utrecht, 3543 AZ
Netherlands
Not yet recruiting
Research Site
Białystok, 15-950
Poland
Recruiting
Research Site
Bydgoszcz, 85-681
Poland
Recruiting
Research Site
Gdańsk, 80-214
Poland
Recruiting
Research Site
Koszalin, 75-581
Poland
Recruiting
Research Site
Olsztyn, 10-513
Poland
Recruiting
Research Site
Piotrków Trybunalski, 97-300
Poland
Recruiting
Research Site
Poznań, 60-848
Poland
Recruiting
Research Site
Warszawa, 02-005
Poland
Recruiting
Research Site
Warszawa, 02-781
Poland
Recruiting
Research Site
Wroclaw, 53-413
Poland
Recruiting
Research Site
Wrocław, 50-556
Poland
Recruiting
Research Site
Ivanovo, 153040
Russian Federation
Recruiting
Research Site
Krasnoyarsk, 660133
Russian Federation
Recruiting
Research Site
Moscow, 115280
Russian Federation
Recruiting
Research Site
Nizhniy Novgorod, 603074
Russian Federation
Recruiting
Research Site
Obninsk, 249036
Russian Federation
Recruiting
Research Site
Omsk, 644013
Russian Federation
Recruiting
Research Site
Saint Petersburg, 195271
Russian Federation
Recruiting
Research Site
St Petersburg, 194044
Russian Federation
Not yet recruiting
Research Site
St. Petersburg, 194017
Russian Federation
Recruiting
Research Site
St. Petersburg, 197758
Russian Federation
Recruiting
Research Site
St.Petersburg, 191014
Russian Federation
Recruiting
Research Site
Vladimir, 600020
Russian Federation
Withdrawn
Research Site
Vologda, 160012
Russian Federation
Recruiting
Research Site
Yaroslavl, 150054
Russian Federation
Recruiting
Research Site
Banka, 921 01
Slovakia
Not yet recruiting
Research Site
Bratislava, 811 08
Slovakia
Not yet recruiting
Research Site
Bratislava, 812 50
Slovakia
Not yet recruiting
Research Site
Martin, 036 59
Slovakia
Not yet recruiting
Research Site
Presov, 08001
Slovakia
Not yet recruiting
Research Site
Badajoz, 06008
Spain
Recruiting
Research Site
Barcelona, 08035
Spain
Recruiting
Research Site
Barcelona, 08036
Spain
Recruiting
Research Site
Barcelona, 08208
Spain
Recruiting
Research Site
Elche(Alicante), 03202
Spain
Recruiting
Research Site
Madrid, 28040
Spain
Recruiting
Research Site
Madrid, 28041
Spain
Recruiting
Research Site
Madrid, 28046
Spain
Recruiting
Research Site
Malaga, 29010
Spain
Recruiting
Research Site
Oviedo, 33011
Spain
Recruiting
Research Site
Pamplona, 31008
Spain
Recruiting
Research Site
Pozuelo de Alarcon, 28223
Spain
Recruiting
Research Site
Sevilla, 41009
Spain
Recruiting
Research Site
Sevilla, 41014
Spain
Recruiting
Research Site
Valencia, 46014
Spain
Recruiting
Research Site
Birmingham, B15 2TH
United Kingdom
Recruiting
Research Site
Cleveland, TS4 3BW
United Kingdom
Withdrawn
Research Site
Glasgow, G12 0YN
United Kingdom
Recruiting
Research Site
Guildford, CU2 7XX
United Kingdom
Recruiting
Research Site
London, EC1A 7BE
United Kingdom
Recruiting
Research Site
London, NW1 2PG
United Kingdom
Recruiting
Research Site
London, SE1 9RY
United Kingdom
Recruiting
Research Site
Sheffield, S10 2RX
United Kingdom
Recruiting
Research Site
Southampton, SO16 6YD
United Kingdom
Recruiting
Research Site
Taunton, TA1 5DA
United Kingdom
Recruiting