English Español
Back to Clinical Trials

Brief Title: Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer.

INTRODUCTION

  • Org Study ID: D933RC00001
  • Secondary ID: 2018-001811-59
  • NTC ID: NCT03732677
  • Sponsor: AstraZeneca

BRIEF SUMMARY

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

  • Overall Status
    Recruiting
  • Start Date
    November 16, 2018
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Pathologic complete response (pCR) rates at time of cystectomy

Primary Outcome 1 - Timeframe: Up to 6 months

Primary Outcome 2 - Measure: Event-free survival (EFS) per central review defined as time from randomization to event

Primary Outcome 2 - Timeframe: Up to 48 months

CONDITION

  • Muscle Invasive Bladder Cancer

ELIGIBILITY

Inclusion:
Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology

- Patients must be planning to undergo a radical cystectomy

- Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC

- ECOG performance status of 0 or 1

- Must have a life expectancy of at least 12 weeks at randomization
Exclusion:
Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening.

- Prior pelvic radiotherapy treatment within 2 years of randomization to study

- Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies.

- Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). 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, CT scan premedication)

- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.

- Uncontrolled intercurrent illness

- Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency

Gender: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

LOCATION

Facility Status Contact
Facility: Research Site
Birmingham, Alabama 35294
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Los Angeles, California 90095
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Palo Alto, California 94304
United States
Status: Recruiting Contact: N/A
Facility: Research Site
New Haven, Connecticut 06520
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Chicago, Illinois 60611
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Westwood, Kansas 66205
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Louisville, Kentucky 40202
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: N/A
Facility: Research Site
New York, New York 10029
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Rochester, New York 14642
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Burlington, Vermont 05401
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: N/A
Facility: Research Site
Brisbane, Alberta 4122
Australia
Status: Recruiting Contact: N/A
Facility: Research Site
Elizabeth Vale, British Columbia 5112
Australia
Status: Recruiting Contact: N/A
Facility: Research Site
Macquarie University, Ontario 2109
Australia
Status: Recruiting Contact: N/A
Facility: Research Site
Melbourne, Ontario 3004
Australia
Status: Recruiting Contact: N/A
Facility: Research Site
Murdoch, Ontario 6150
Australia
Status: Recruiting Contact: N/A
Facility: Research Site
South Brisbane, Quebec 4101
Australia
Status: Recruiting Contact: N/A
Facility: Research Site
Brugge, Quebec 8000
Belgium
Status: Recruiting Contact: N/A
Facility: Research Site
Charleroi, 6000
Belgium
Status: Recruiting Contact: N/A
Facility: Research Site
Kortrijk, 8500
Belgium
Status: Recruiting Contact: N/A
Facility: Research Site
Leuven, 3000
Belgium
Status: Recruiting Contact: N/A
Facility: Research Site
Liège, 4000
Belgium
Status: Recruiting Contact: N/A
Facility: Research Site
Roeselare, 8800
Belgium
Status: Recruiting Contact: N/A
Facility: Research Site
Edmonton, T6G 1Z2
Canada
Status: Recruiting Contact: N/A
Facility: Research Site
Vancouver, V5Z 4E6
Canada
Status: Recruiting Contact: N/A
Facility: Research Site
Ottawa, K1H 8L6
Canada
Status: Recruiting Contact: N/A
Facility: Research Site
Toronto, M5G IX6
Canada
Status: Recruiting Contact: N/A
Facility: Research Site
Montreal, H2X 0C2
Canada
Status: Recruiting Contact: N/A
Facility: Research Site
Sherbrooke, J1H 5N4
Canada
Status: Recruiting Contact: N/A
Facility: Research Site
Antofagasta, 1267348
Chile
Status: Recruiting Contact: N/A
Facility: Research Site
Santiago, 7520349
Chile
Status: Recruiting Contact: N/A
Facility: Research Site
Temuco, 4810469
Chile
Status: Recruiting Contact: N/A
Facility: Research Site
Viña del Mar, 2540488
Chile
Status: Recruiting Contact: N/A
Facility: Research Site
Brno, 656 53
Czechia
Status: Recruiting Contact: N/A
Facility: Research Site
Brno, 656 91
Czechia
Status: Recruiting Contact: N/A
Facility: Research Site
Hradec Kralove, 500 05
Czechia
Status: Recruiting Contact: N/A
Facility: Research Site
Olomouc, 779 00
Czechia
Status: Recruiting Contact: N/A
Facility: Research Site
Praha 2, 128 08
Czechia
Status: Recruiting Contact: N/A
Facility: Research Site
Praha, 140 59
Czechia
Status: Recruiting Contact: N/A
Facility: Research Site
Angers Cedex 01, 49033
France
Status: Recruiting Contact: N/A
Facility: Research Site
Dijon, 21079
France
Status: Recruiting Contact: N/A
Facility: Research Site
Grenoble Cedex 09, 38043
France
Status: Recruiting Contact: N/A
Facility: Research Site
Montpellier, 34070
France
Status: Recruiting Contact: N/A
Facility: Research Site
Nimes, 30029
France
Status: Recruiting Contact: N/A
Facility: Research Site
Pierre Benite, 69495
France
Status: Recruiting Contact: N/A
Facility: Research Site
Poitiers Cedex, 86021
France
Status: Recruiting Contact: N/A
Facility: Research Site
Bergisch Gladbach, 51465
Germany
Status: Recruiting Contact: N/A
Facility: Research Site
Bonn, 53127
Germany
Status: Recruiting Contact: N/A
Facility: Research Site
Göttingen, 37075
Germany
Status: Recruiting Contact: N/A
Facility: Research Site
Herne, 44625
Germany
Status: Recruiting Contact: N/A
Facility: Research Site
Jena, 07747
Germany
Status: Recruiting Contact: N/A
Facility: Research Site
Köln, 50937
Germany
Status: Recruiting Contact: N/A
Facility: Research Site
Magdeburg, 39120
Germany
Status: Recruiting Contact: N/A
Facility: Research Site
Mannheim, 68167
Germany
Status: Recruiting Contact: N/A
Facility: Research Site
Münster, 48149
Germany
Status: Recruiting Contact: N/A
Facility: Research Site
Würzburg, 97080
Germany
Status: Recruiting Contact: N/A
Facility: Research Site
Haifa, 31096
Israel
Status: Recruiting Contact: N/A
Facility: Research Site
Jerusalem, 91120
Israel
Status: Recruiting Contact: N/A
Facility: Research Site
Kfar Saba, 95847
Israel
Status: Recruiting Contact: N/A
Facility: Research Site
Petach-Tikva, 4941492
Israel
Status: Recruiting Contact: N/A
Facility: Research Site
Ramat Gan, 52621
Israel
Status: Recruiting Contact: N/A
Facility: Research Site
Bari, 70124
Italy
Status: Recruiting Contact: N/A
Facility: Research Site
Firenze, 50134
Italy
Status: Recruiting Contact: N/A
Facility: Research Site
Milano, 20132
Italy
Status: Recruiting Contact: N/A
Facility: Research Site
Milano, 20133
Italy
Status: Recruiting Contact: N/A
Facility: Research Site
Napoli, 80131
Italy
Status: Recruiting Contact: N/A
Facility: Research Site
Orbassano, 10043
Italy
Status: Recruiting Contact: N/A
Facility: Research Site
Pozzuoli, 80078
Italy
Status: Recruiting Contact: N/A
Facility: Research Site
Verona, 37126
Italy
Status: Recruiting Contact: N/A
Facility: Research Site
Bunkyo-ku, 113-8603
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Fukuoka-shi, 811-1347
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Fukuoka, 812-8582
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Hirosaki-shi, 036-8563
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Hiroshima-shi, 730-8518
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Kanazawa-shi, 920-8641
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Koto-ku, 135-8550
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Kumamoto-shi, 860-0008
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Miyazaki-city, 889-1692
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Nagasaki-shi, 852-8501
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Nagoya-shi, 466-8560
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Niigata-shi, 951-8520
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Osaka-shi, 541-8567
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Osaka-shi, 545-8586
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Osakasayama-shi, 589-8511
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Sendai-shi, 980-0872
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Toyama-shi, 930-0194
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Tsukuba-shi, 305-8576
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Yokohama-shi, 232-0024
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Yokohama-shi, 241-8515
Japan
Status: Recruiting Contact: N/A
Facility: Research Site
Amsterdam, 1066 CX
Netherlands
Status: Recruiting Contact: N/A
Facility: Research Site
Breda, 4818 CK
Netherlands
Status: Recruiting Contact: N/A
Facility: Research Site
Rotterdam, 3015 GD
Netherlands
Status: Recruiting Contact: N/A
Facility: Research Site
Baguio City, 2600
Philippines
Status: Recruiting Contact: N/A
Facility: Research Site
Cebu, 6000
Philippines
Status: Recruiting Contact: N/A
Facility: Research Site
Davao City, 8000
Philippines
Status: Recruiting Contact: N/A
Facility: Research Site
Makati, 1229
Philippines
Status: Recruiting Contact: N/A
Facility: Research Site
Manila, 1015
Philippines
Status: Recruiting Contact: N/A
Facility: Research Site
Quezon City, 1101
Philippines
Status: Recruiting Contact: N/A
Facility: Research Site
Quezon City, 1104
Philippines
Status: Recruiting Contact: N/A
Facility: Research Site
Grudziądz, 86-300
Poland
Status: Recruiting Contact: N/A
Facility: Research Site
Krasnoyarsk, 660133
Russian Federation
Status: Recruiting Contact: N/A
Facility: Research Site
Moscow, 105077
Russian Federation
Status: Recruiting Contact: N/A
Facility: Research Site
Nizhniy Novgorod, 603074
Russian Federation
Status: Recruiting Contact: N/A
Facility: Research Site
Novosibirsk, 630007
Russian Federation
Status: Recruiting Contact: N/A
Facility: Research Site
Samara, 443031
Russian Federation
Status: Recruiting Contact: N/A
Facility: Research Site
St Petersburg, 194044
Russian Federation
Status: Recruiting Contact: N/A
Facility: Research Site
St. Petersburg, 197022
Russian Federation
Status: Recruiting Contact: N/A
Facility: Research Site
Ufa, 450000
Russian Federation
Status: Recruiting Contact: N/A
Facility: Research Site
Badalona, 08916
Spain
Status: Recruiting Contact: N/A
Facility: Research Site
Barcelona, 08035
Spain
Status: Recruiting Contact: N/A
Facility: Research Site
Córdoba, 14004
Spain
Status: Recruiting Contact: N/A
Facility: Research Site
Las Palmas de Gran Canaria, 35016
Spain
Status: Recruiting Contact: N/A
Facility: Research Site
Madrid, 28007
Spain
Status: Recruiting Contact: N/A
Facility: Research Site
Madrid, 28041
Spain
Status: Recruiting Contact: N/A
Facility: Research Site
Santander, 39008
Spain
Status: Recruiting Contact: N/A
Facility: Research Site
Sevilla, 41013
Spain
Status: Recruiting Contact: N/A
Facility: Research Site
Kaohsiung, 807
Taiwan
Status: Recruiting Contact: N/A
Facility: Research Site
Taichung, 40443
Taiwan
Status: Recruiting Contact: N/A
Facility: Research Site
Taichung, 40705
Taiwan
Status: Recruiting Contact: N/A
Facility: Research Site
Tainan, 704
Taiwan
Status: Recruiting Contact: N/A
Facility: Research Site
Tainan, 710
Taiwan
Status: Recruiting Contact: N/A
Facility: Research Site
Taipei City, 10050
Taiwan
Status: Recruiting Contact: N/A
Facility: Research Site
Taipei, 11217
Taiwan
Status: Recruiting Contact: N/A
Facility: Research Site
Taoyuan, 333
Taiwan
Status: Recruiting Contact: N/A
Facility: Research Site
Ankara, 06590
Turkey
Status: Recruiting Contact: N/A
Facility: Research Site
Edirne, 22030
Turkey
Status: Recruiting Contact: N/A
Facility: Research Site
Istanbul, 34030
Turkey
Status: Recruiting Contact: N/A
Facility: Research Site
İstanbul, 34457
Turkey
Status: Recruiting Contact: N/A
Facility: Research Site
Izmir, 35575
Turkey
Status: Recruiting Contact: N/A
Facility: Research Site
Karsiyaka, EH4 2XR
Turkey
Status: Recruiting Contact: N/A
Facility: Research Site
Edinburgh, E1 1BB
United Kingdom
Status: Recruiting Contact: N/A
Facility: Research Site
London, NG5 1PB
United Kingdom
Status: Recruiting Contact: N/A
Facility: Research Site
Sheffield, CH63 4JY
United Kingdom
Status: Recruiting Contact: N/A
Facility: Research Site
Wirral, 100000
United Kingdom
Status: Recruiting Contact: N/A
Facility: Research Site
Hanoi City, 700000
Vietnam
Status: Recruiting Contact: N/A
Facility: Research Site
Ho Chi Minh, 70000
Vietnam
Status: Recruiting Contact: N/A
Facility: Research Site
Hochiminh,
Vietnam
Status: Recruiting Contact: N/A