Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC (NIAGARA)

June 26, 2026 updated by: AstraZeneca

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.

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1063

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia, 4122
        • Research Site
      • Elizabeth Vale, Australia, 5112
        • Research Site
      • Macquarie University, Australia, 2109
        • Research Site
      • Melbourne, Australia, 3004
        • Research Site
      • Murdoch, Australia, 6150
        • Research Site
      • South Brisbane, Australia, 4101
        • Research Site
  • Belgium
      • Bruges, Belgium, 8000
        • Research Site
      • Charleroi, Belgium, 6000
        • Research Site
      • Kortrijk, Belgium, 8500
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Porto Alegre, Brazil, 90610-000
        • Research Site
      • Porto Alegre, Brazil, 91350-200
        • Research Site
      • Porto Alegre, Brazil, 90020-090
        • Research Site
      • Porto Alegre, Brazil, 90470-340
        • Research Site
      • Rio de Janeiro, Brazil, 20231-050
        • Research Site
      • Santa Maria, Brazil, 97015-450
        • Research Site
      • São José do Rio Preto, Brazil, 15090-000
        • Research Site
      • São Paulo, Brazil, 03102-002
        • Research Site
      • São Paulo, Brazil, 01246-000
        • Research Site
      • São Paulo, Brazil, 01509-900
        • Research Site
      • São Paulo, Brazil, 01323-903
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Research Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
      • Toronto, Ontario, Canada, M5G IX6
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C2
        • Research Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Research Site
  • Chile
      • Antofagasta, Chile, 1267348
        • Research Site
      • Port Montt, Chile, 5480000
        • Research Site
      • Santiago, Chile, 7520349
        • Research Site
      • Temuco, Chile, 4810218
        • Research Site
      • Temuco, Chile, 4810469
        • Research Site
      • Viña del Mar, Chile, 2540488
        • Research Site
  • Czechia
      • Brno, Czechia, 656 53
        • Research Site
      • Brno, Czechia, 656 91
        • Research Site
      • Hradec Králové, Czechia, 500 05
        • Research Site
      • Olomouc, Czechia, 77900
        • Research Site
      • Prague, Czechia, 128 08
        • Research Site
      • Prague, Czechia, 140 59
        • Research Site
      • Prague, Czechia, 180 81
        • Research Site
  • France
      • Angers, France, 49033
        • Research Site
      • Dijon, France, 21079
        • Research Site
      • Grenoble, France, 38043
        • Research Site
      • Montpellier, France, 34070
        • Research Site
      • Nîmes, France, 30029
        • Research Site
      • Pierre-Bénite, France, 69495
        • Research Site
      • Poitiers, France, 86021
        • Research Site
      • Rouen, France, F-76031 CE
        • Research Site
  • Germany
      • Bergisch Gladbach, Germany, 51465
        • Research Site
      • Bonn, Germany, 53127
        • Research Site
      • Cologne, Germany, 50937
        • Research Site
      • Erlangen, Germany, 91054
        • Research Site
      • Göttingen, Germany, 37075
        • Research Site
      • Herne, Germany, 44625
        • Research Site
      • Jena, Germany, 07747
        • Research Site
      • Magdeburg, Germany, 39120
        • Research Site
      • Mannheim, Germany, 68167
        • Research Site
      • Münster, Germany, 48149
        • Research Site
      • Nuremberg, Germany, 90491
        • Research Site
      • Oldenburg, Germany, 23758
        • Research Site
      • Regensburg, Germany, 93053
        • Research Site
      • Ulm, Germany, 89081
        • Research Site
      • Würzburg, Germany, 97080
        • Research Site
  • Israel
      • Haifa, Israel, 31096
        • Research Site
      • Jerusalem, Israel, 91120
        • Research Site
      • Kfar Saba, Israel, 95847
        • Research Site
      • Petah Tikva, Israel, 4941492
        • Research Site
      • Ramat Gan, Israel, 52621
        • Research Site
  • Italy
      • Bari, Italy, 70124
        • Research Site
      • Bologna, Italy, 40138
        • Research Site
      • Florence, Italy, 50134
        • Research Site
      • Milan, Italy, 20132
        • Research Site
      • Milan, Italy, 20133
        • Research Site
      • Naples, Italy, 80131
        • Research Site
      • Orbassano, Italy, 10043
        • Research Site
      • Pozzuoli, Italy, 80078
        • Research Site
      • Verona, Italy, 37126
        • Research Site
  • Japan
      • Bunkyō City, Japan, 113-8603
        • Research Site
      • Fukuoka, Japan, 812-8582
        • Research Site
      • Fukuoka, Japan, 811-1347
        • Research Site
      • Hirosaki-shi, Japan, 036-8563
        • Research Site
      • Hiroshima, Japan, 730-8518
        • Research Site
      • Kanazawa, Japan, 920-8641
        • Research Site
      • Kumamoto, Japan, 860-0008
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Research Site
      • Miyazaki, Japan, 889-1692
        • Research Site
      • Nagasaki, Japan, 852-8501
        • Research Site
      • Nagoya, Japan, 466-8560
        • Research Site
      • Niigata, Japan, 951-8520
        • Research Site
      • Osaka, Japan, 545-8586
        • Research Site
      • Osaka, Japan, 541-8567
        • Research Site
      • Osakasayama-shi, Japan, 589-8511
        • Research Site
      • Sendai, Japan, 980-0872
        • Research Site
      • Toyama, Japan, 930-0194
        • Research Site
      • Tsukuba, Japan, 305-8576
        • Research Site
      • Yokohama, Japan, 241-8515
        • Research Site
      • Yokohama, Japan, 232-0024
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Research Site
      • Amsterdam, Netherlands, 1081 HV
        • Research Site
      • Breda, Netherlands, 4818 CK
        • Research Site
      • Rotterdam, Netherlands, 3015 GD
        • Research Site
  • Philippines
      • Baguio City, Philippines, 2600
        • Research Site
      • Cebu, Philippines, 6000
        • Research Site
      • Davao City, Philippines, 8000
        • Research Site
      • Makati, Philippines, 1229
        • Research Site
      • Manila, Philippines, 1015
        • Research Site
      • Quezon City, Philippines, 1104
        • Research Site
      • Quezon City, Philippines, 1101
        • Research Site
  • Poland
      • Bialystok, Poland, 15-027
        • Research Site
      • Gdansk, Poland, 80-952
        • Research Site
      • Grudziądz, Poland, 86-300
        • Research Site
      • Koszalin, Poland, 75-581
        • Research Site
      • Krakow, Poland, 30-510
        • Research Site
      • Olsztyn, Poland, 10-228
        • Research Site
      • Ostrołęka, Poland, 07-410
        • Research Site
      • Poznan, Poland, 60-693
        • Research Site
      • Warsaw, Poland, 02-781
        • Research Site
      • Wroclaw, Poland, 53-413
        • Research Site
  • Russia
      • Krasnoyarsk, Russia, 660133
        • Research Site
      • Moscow, Russia, 105077
        • Research Site
      • Nizhny Novgorod, Russia, 603074
        • Research Site
      • Novosibirsk, Russia, 630007
        • Research Site
      • Saint Petersburg, Russia, 194354
        • Research Site
      • Saint Petersburg, Russia, 197022
        • Research Site
      • Saint Petersburg, Russia, 194017
        • Research Site
      • Saint Petersburg, Russia, 194044
        • Research Site
      • Samara, Russia, 443031
        • Research Site
      • Ufa, Russia, 450000
        • Research Site
      • Vologda, Russia, 160012
        • Research Site
  • South Korea
      • Daegu, South Korea, 41404
        • Research Site
      • Goyang-si, South Korea, 10408
        • Research Site
      • Gyeonggi-do, South Korea, 13620
        • Research Site
      • Incheon, South Korea, 21565
        • Research Site
      • Seoul, South Korea, 03080
        • Research Site
      • Seoul, South Korea, 05505
        • Research Site
      • Seoul, South Korea, 136-705
        • Research Site
  • Spain
      • Badalona, Spain, 08916
        • Research Site
      • Barcelona, Spain, 08035
        • Research Site
      • Córdoba, Spain, 14004
        • Research Site
      • Las Palmas de Gran Canaria, Spain, 35016
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Santander, Spain, 39008
        • Research Site
      • Seville, Spain, 41013
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 404
        • Research Site
      • Tainan, Taiwan, 704
        • Research Site
      • Tainan, Taiwan, 710
        • Research Site
      • Taipei, Taiwan, 11217
        • Research Site
      • Taipei, Taiwan, 10050
        • Research Site
      • Taoyuan City, Taiwan, 333
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06590
        • Research Site
      • Cordaleo, Turkey (Türkiye), 35575
        • Research Site
      • Edirne, Turkey (Türkiye), 22030
        • Research Site
      • Istanbul, Turkey (Türkiye), 34030
        • Research Site
      • Istanbul, Turkey (Türkiye), 34457
        • Research Site
      • Izmir, Turkey (Türkiye)
        • Research Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XR
        • Research Site
      • London, United Kingdom, E1 1BB
        • Research Site
      • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Research Site
      • Sheffield, United Kingdom, S10 2SJ
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
    • California
      • Los Angeles, California, United States, 90095
        • Research Site
      • Palo Alto, California, United States, 94304
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Research Site
      • Geneva, Illinois, United States, 60134
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Research Site
    • Maryland
      • Towson, Maryland, United States, 21204
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
      • Detroit, Michigan, United States, 48201
        • Research Site
    • New York
      • New York, New York, United States, 10029
        • Research Site
      • Rochester, New York, United States, 14642
        • Research Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Research Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Research Site
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Research Site
      • Hochiminh, Vietnam, 70000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response (pCR) Rates at Time of Cystectomy
Time Frame: Up to 6 months
pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed per central pathology review using specimens obtained via radical cystectomy following the neoadjuvant treatment. The denominator for pCR will be the number of patients in the FAS.
Up to 6 months
Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event
Time Frame: Up to 48 months
EFS is defined as the time from randomization to the first recurrence of disease post radical cystectomy, time of first documented progression in patients who were medically precluded for radical cystectomy, or time of expected surgery in patients who refuse to undergo a radical cystectomy or failure to undergo a radical cystectomy in participants with residual disease, or the time of death due to any cause, whichever occurs first
Up to 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event
Time Frame: Up to 24 months
EFS24 is defined as the Kaplan-Meier estimate of EFS at 24 months after randomization, as assessed per blinded independent central review or by central pathology review if a biopsy is required for a suspected new lesion, and per local investigator or local biopsy review if a biopsy is required for a suspected new lesion
Up to 24 months
Proportion of Patients Who Undergo Cystectomy
Time Frame: Up to 6 months
The proportion of patients who undergo cystectomy is defined as the proportion patients who undergo radical cystectomy after the neoadjuvant treatment. The denominator will be patients in the FAS.
Up to 6 months
Overall Survival
Time Frame: Up to 65 months
OS is defined as the time from the date of randomization until death due to any cause regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy (i.e., date of death or censoring - date of randomization + 1)
Up to 65 months
Metastasis-free Survival Per Investigator Assessment or Local Biopsy Review.
Time Frame: Up to 48 months
MFS is defined as the time from date of randomization until the first recognition of distant metastases or death, whichever occurs first
Up to 48 months
Disease-specific Survival Per Investigator Assessment or Local Biopsy Review.
Time Frame: Up to 48 months
DSS is defined as the time from the date of randomization until death due to bladder cancer
Up to 48 months
Immunogenicity of Durvalumab When Used in Combination With Gemcitabine/Cisplatin as Measured by Presence of Antidrug Antibodies (ADA)
Time Frame: Up to 12 months
Whole blood samples for assessing ADA for durvalumab in serum were collected from patients undergoing durvalumab treatment, following the specified assessment schedule. ADA prevalence is the proportion of patients with a positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA includes both treatment-induced and treatment-boosted ADA. Its incidence is the proportion of patients with treatment-emergent ADA positivity. Treatment-boosted ADA refers to a baseline-positive ADA titer that increased ≥4-fold during the study. Persistently positive patients have at least two post-baseline ADA-positive readings, with at least 16 weeks between the first and last, or an ADA-positive result at the final assessment. This includes baseline-positive patients meeting these criteria. Transiently positive is defined by at least one post-baseline ADA-positive reading without being persistently positive, including baseline-positive patients meeting these terms.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2018

Primary Completion (Actual)

April 29, 2024

Study Completion (Estimated)

November 8, 2027

Study Registration Dates

First Submitted

October 5, 2018

First Submitted That Met QC Criteria

November 5, 2018

First Posted (Actual)

November 6, 2018

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D933RC00001
  • 2018-001811-59 (EudraCT Number)
  • 2023-510015-19-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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 rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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