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History of Changes for Study: NCT03732677
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC (NIAGARA)
Latest version (submitted May 12, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 5, 2018 None (earliest Version on record)
2 November 29, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 January 7, 2019 Contacts/Locations and Study Status
4 February 5, 2019 Contacts/Locations and Study Status
5 March 7, 2019 Contacts/Locations and Study Status
6 April 3, 2019 Contacts/Locations and Study Status
7 April 30, 2019 Contacts/Locations and Study Status
8 June 6, 2019 Contacts/Locations, Outcome Measures, Study Status and Eligibility
9 July 3, 2019 Study Status
10 August 28, 2019 Contacts/Locations and Study Status
11 September 27, 2019 Contacts/Locations and Study Status
12 October 28, 2019 Study Status and Contacts/Locations
13 December 6, 2019 Contacts/Locations and Study Status
14 January 10, 2020 Contacts/Locations and Study Status
15 February 6, 2020 Contacts/Locations, Outcome Measures, Study Status and Eligibility
16 March 5, 2020 Contacts/Locations and Study Status
17 March 31, 2020 Study Status and Study Identification
18 April 30, 2020 Contacts/Locations and Study Status
19 June 4, 2020 Study Status, IPDSharing and Contacts/Locations
20 July 1, 2020 Contacts/Locations, Study Status and Oversight
21 July 22, 2020 Contacts/Locations and Study Status
22 September 17, 2020 Contacts/Locations, Study Status and Eligibility
23 October 15, 2020 Study Status and Contacts/Locations
24 November 16, 2020 Study Status and Contacts/Locations
25 December 16, 2020 Contacts/Locations and Study Status
26 January 14, 2021 Contacts/Locations and Study Status
27 February 22, 2021 Contacts/Locations and Study Status
28 March 24, 2021 Contacts/Locations and Study Status
29 April 23, 2021 Contacts/Locations and Study Status
30 May 27, 2021 Contacts/Locations and Study Status
31 July 7, 2021 Contacts/Locations, Study Status and Outcome Measures
32 August 6, 2021 Study Status and Contacts/Locations
33 September 10, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
34 January 14, 2022 Study Status and Study Identification
35 April 14, 2022 Contacts/Locations, Study Status and Study Identification
36 May 12, 2022 Study Status and Study Design
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Study NCT03732677
Submitted Date:  November 5, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: D933RC00001
Brief Title: Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC (NIAGARA)
Official Title: 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
Secondary IDs: 2018-001811-59 [EudraCT Number]
Open or close this module Study Status
Record Verification: November 2018
Overall Status: Not yet recruiting
Study Start: November 28, 2018
Primary Completion: December 30, 2025 [Anticipated]
Study Completion: December 30, 2025 [Anticipated]
First Submitted: October 5, 2018
First Submitted that
Met QC Criteria:
November 5, 2018
First Posted: November 6, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
November 5, 2018
Last Update Posted: November 6, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: AstraZeneca
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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
Detailed Description:
Open or close this module Conditions
Conditions: Muscle Invasive Bladder Cancer
Keywords: Bladder Cancer
Immunotherapy
PD-L1
Durvalumab (MEDI4736)
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1050 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm 1
Chemotherapy + Durvalumab
Drug: Durvalumab
Anti- PD-L1 Antibody
Drug: Cisplatin
Chemotherapy Agent
Drug: Gemcitabine
Chemotherapy agent
Active Comparator: Arm 2
Chemotherapy alone
Drug: Cisplatin
Chemotherapy Agent
Drug: Gemcitabine
Chemotherapy agent
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Pathologic complete response (pCR) rates at time of cystectomy following neoadjuvant treatment, as assessed by central pathology review
[ Time Frame: Up to 36 months ]

2. Event-free survival (EFS) per central review defined as time from randomization to the first recurrence of disease (after cystectomy), or progression in patients who were precluded for cystectomy, or death due to any cause, whichever occurs first
[ Time Frame: Up to 48 months ]

Secondary Outcome Measures:
1. Proportion of patients who achieve <P2 (Pa,P1 and Cis) at time of cystectomy following neoadjuvant treatment, as assessed by central pathology review
[ Time Frame: Up to 36 months ]

2. EFS at 24 months (EFS24) defined as time from randomization to the first recurrence of disease (after cystectomy), or first progression in patients who were precluded for cystectomy, or death due to any cause, whichever occurs first
[ Time Frame: Up to 24 months ]

3. Proportion of patients who undergo cystectomy
[ Time Frame: Up to 36 months ]

4. Overall survival rate at 5 years, as determined based on time from date of randomization to date of death, from any cause
[ Time Frame: Up to 84 months ]

5. Safety and Tolerability as evaluated by adverse events occurring throughout the study
[ Time Frame: Up to 84 months ]

6. Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA)
[ Time Frame: Up to 12 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 130 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion:

  • Patient resectable muscle-invasive bladder cancer with clinical stage T2N0M0-T4aN0M0 with transitional cell histology
  • Patients must be planning to undergo a radical cystectomy at the time of randomization
  • 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 or metastatic disease at time of screening.
  • Prior pelvic radiotherapy treatment
  • 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
Open or close this module Contacts/Locations
Central Contact Person: AstraZeneca Clinical Study Information Center
Telephone: 1-877-240-9479
Email: information.center@astrazeneca.com
Locations: United States, Alabama
Research Site
Birmingham, Alabama, United States, 35294
United States, California
Research Site
Fountain Valley, California, United States, 92708
Research Site
Fullerton, California, United States, 92835
Research Site
Los Angeles, California, United States, 90095
Research Site
Salinas, California, United States, 93901
United States, Colorado
Research Site
Denver, Colorado, United States, 80211
United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06520
United States, Florida
Research Site
Tampa, Florida, United States, 33612
United States, Illinois
Research Site
Chicago, Illinois, United States, 60611
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
Research Site
New Orleans, Louisiana, United States, 70112
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Research Site
Detroit, Michigan, United States, 48201
United States, New York
Research Site
New York, New York, United States, 10029
Research Site
Rochester, New York, United States, 14642
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27705
United States, Ohio
Research Site
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Research Site
Bethlehem, Pennsylvania, United States, 18015
Australia
Research Site
Box Hill, Australia, 3128
Research Site
Elizabeth Vale, Australia, 5112
Research Site
Herston, Australia, 4029
Research Site
Macquarie University, Australia, 2109
Research Site
Murdoch, Australia, 6150
Research Site
South Brisbane, Australia, 4101
Brazil
Research Site
São José do Rio Preto, Brazil, 15090-000
Canada, Alberta
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8V 5C2
Research Site
London, Ontario, Canada, N6A 4L6
Research Site
Toronto, Ontario, Canada, M5G IX6
Chile
Research Site
Antofagasta, Chile, 1267348
Research Site
Puerto Montt, Chile, 5480000
Czechia
Research Site
Hradec Kralove, Czechia, 500 05
Research Site
Olomouc, Czechia, 779 00
Germany
Research Site
Fürth, Germany, 90763
Research Site
Köln, Germany, 50937
Research Site
Magdeburg, Germany, 39120
Research Site
Ulm, Germany, 89081
Research Site
Würzburg, Germany, 97080
Japan
Research Site
Bunkyo-ku, Japan, 113-8603
Research Site
Fukuoka, Japan, 812-8582
Research Site
Hirosaki-shi, Japan, 036-8563
Research Site
Kanazawa-shi, Japan, 920-8641
Research Site
Koto-ku, Japan, 135-8550
Research Site
Miyazaki-city, Japan, 889-1692
Research Site
Nagasaki-shi, Japan, 852-8501
Research Site
Nagoya-shi, Japan, 466-8560
Research Site
Niigata-shi, Japan, 951-8520
Research Site
Osaka-shi, Japan, 541-8567
Research Site
Osaka-shi, Japan, 545-0051
Research Site
Osakasayama-shi, Japan, 589-8511
Research Site
Shinjuku-ku, Japan, 160-8582
Research Site
Toyama-shi, Japan, 930-0194
Research Site
Tsukuba-shi, Japan, 305-8576
Research Site
Yokohama-shi, Japan, 232-0024
Korea, Republic of
Research Site
Daegu, Korea, Republic of, 41404
Research Site
Goyang-si, Korea, Republic of, 10408
Research Site
Incheon, Korea, Republic of, 21565
Research Site
Seongnam, Korea, Republic of, 13620
Research Site
Seoul, Korea, Republic of, 03080
Research Site
Seoul, Korea, Republic of, 136-705
Philippines
Research Site
Baguio City, Philippines, 2600
Research Site
Cebu, Philippines, 6000
Research Site
Davao City, Philippines, 8000
Research Site
Makati, Philippines, 1229
Research Site
Manila, Philippines
Research Site
Quezon City, Philippines, 1104
Research Site
Quezon City, Philippines
Poland
Research Site
Bialystok, Poland, 15-027
Research Site
Gdańsk, Poland, 80-952
Research Site
Grudziądz, Poland, 86-300
Research Site
Koszalin, Poland, 75-581
Research Site
Warszawa, Poland, 02-616
Research Site
Warszawa, Poland, 02-781
Research Site
Wroclaw, Poland, 53-413
Research Site
Łódź, Poland, 93-509
Russian Federation
Research Site
Krasnoyarsk, Russian Federation, 660133
Research Site
Nizhnyi Novgorod, Russian Federation, 603001
Research Site
Omsk, Russian Federation, 644013
Research Site
Samara, Russian Federation, 443031
Research Site
St. Petersburg, Russian Federation, 194017
Research Site
St. Petersburg, Russian Federation, 194354
Research Site
Vologda, Russian Federation, 160002
Taiwan
Research Site
Kaohsiung, Taiwan
Research Site
Taichung, Taiwan, 404
Research Site
Taipei, Taiwan, 11217
Turkey
Research Site
Ankara, Turkey, 06590
Research Site
Edirne, Turkey, 22030
Research Site
Istanbul, Turkey, 34030
Research Site
Izmir, Turkey
United Kingdom
Research Site
Edinburgh, United Kingdom, EH4 2XR
Research Site
London, United Kingdom, EC1A 7BE
Research Site
Nottingham, United Kingdom, NG5 1PB
Research Site
Wirral, United Kingdom, CH63 4JY
Vietnam
Research Site
Ha Noi, Vietnam, 100000
Research Site
Ho Chi Minh, Vietnam, 700000
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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