Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
NIAGARA
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.
3 other identifiers
interventional
1,063
22 countries
188
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2018
Longer than P75 for phase_3
188 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2018
CompletedFirst Posted
Study publicly available on registry
November 6, 2018
CompletedStudy Start
First participant enrolled
November 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2024
CompletedResults Posted
Study results publicly available
July 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedMarch 13, 2026
February 1, 2026
5.5 years
October 5, 2018
April 28, 2025
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pathologic Complete Response (pCR) Rates at Time of Cystectomy
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
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 Outcomes (6)
Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event
Up to 24 months
Proportion of Patients Who Undergo Cystectomy
Up to 6 months
Overall Survival
Up to 65 months
Metastasis-free Survival Per Investigator Assessment or Local Biopsy Review.
Up to 48 months
Disease-specific Survival Per Investigator Assessment or Local Biopsy Review.
Up to 48 months
- +1 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALChemotherapy + Durvalumab
Arm 2
ACTIVE COMPARATORChemotherapy alone
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (188)
Research Site
Birmingham, Alabama, 35294, United States
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Los Angeles, California, 90095, United States
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Palo Alto, California, 94304, United States
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New Haven, Connecticut, 06520, United States
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Chicago, Illinois, 60611, United States
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Geneva, Illinois, 60134, United States
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Iowa City, Iowa, 52242, United States
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Westwood, Kansas, 66205, United States
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Louisville, Kentucky, 40202, United States
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New Orleans, Louisiana, 70112, United States
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Towson, Maryland, 21204, United States
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Ann Arbor, Michigan, 48109, United States
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Detroit, Michigan, 48201, United States
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New York, New York, 10029, United States
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Rochester, New York, 14642, United States
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Bethlehem, Pennsylvania, 18015, United States
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Burlington, Vermont, 05401, United States
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Milwaukee, Wisconsin, 53226, United States
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Brisbane, 4122, Australia
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Elizabeth Vale, 5112, Australia
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Macquarie University, 2109, Australia
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Melbourne, 3004, Australia
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Murdoch, 6150, Australia
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South Brisbane, 4101, Australia
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Bruges, 8000, Belgium
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Charleroi, 6000, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Roeselare, 8800, Belgium
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Barretos, 14784-400, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90470-340, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Rio de Janeiro, 20231-050, Brazil
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Santa Maria, 97015-450, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01323-903, Brazil
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São Paulo, 01509-900, Brazil
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São Paulo, 03102-002, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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London, Ontario, N6A 5W9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G IX6, Canada
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Montreal, Quebec, H2X 0C2, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Antofagasta, 1267348, Chile
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Port Montt, 5480000, Chile
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Santiago, 7520349, Chile
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Temuco, 4810218, Chile
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Temuco, 4810469, Chile
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Viña del Mar, 2540488, Chile
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Brno, 656 53, Czechia
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Brno, 656 91, Czechia
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Hradec Králové, 500 05, Czechia
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Olomouc, 77900, Czechia
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Prague, 128 08, Czechia
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Prague, 140 59, Czechia
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Prague, 180 81, Czechia
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Angers, 49033, France
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Dijon, 21079, France
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Grenoble, 38043, France
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Montpellier, 34070, France
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Nîmes, 30029, France
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Pierre-Bénite, 69495, France
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Poitiers, 86021, France
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Rouen, F-76031 CE, France
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Bergisch Gladbach, 51465, Germany
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Bonn, 53127, Germany
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Cologne, 50937, Germany
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Erlangen, 91054, Germany
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Göttingen, 37075, Germany
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Herne, 44625, Germany
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Jena, 07747, Germany
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Magdeburg, 39120, Germany
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Mannheim, 68167, Germany
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Münster, 48149, Germany
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Nuremberg, 90491, Germany
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Oldenburg, 23758, Germany
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Regensburg, 93053, Germany
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Ulm, 89081, Germany
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Würzburg, 97080, Germany
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 95847, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 52621, Israel
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Bari, 70124, Italy
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Bologna, 40138, Italy
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Florence, 50134, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Naples, 80131, Italy
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Orbassano, 10043, Italy
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Pozzuoli, 80078, Italy
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Verona, 37126, Italy
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Bunkyō City, 113-8603, Japan
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Fukuoka, 811-1347, Japan
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Fukuoka, 812-8582, Japan
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Hirosaki-shi, 036-8563, Japan
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Hiroshima, 730-8518, Japan
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Kanazawa, 920-8641, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-0008, Japan
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Miyazaki, 889-1692, Japan
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Nagasaki, 852-8501, Japan
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Nagoya, 466-8560, Japan
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Niigata, 951-8520, Japan
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Osaka, 541-8567, Japan
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Osaka, 545-8586, Japan
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Osakasayama-shi, 589-8511, Japan
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Sendai, 980-0872, Japan
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Toyama, 930-0194, Japan
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Tsukuba, 305-8576, Japan
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Yokohama, 232-0024, Japan
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Yokohama, 241-8515, Japan
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Amsterdam, 1066 CX, Netherlands
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Amsterdam, 1081 HV, Netherlands
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Breda, 4818 CK, Netherlands
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Rotterdam, 3015 GD, Netherlands
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Baguio City, 2600, Philippines
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Cebu, 6000, Philippines
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Davao City, 8000, Philippines
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Makati, 1229, Philippines
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Manila, 1015, Philippines
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Quezon City, 1101, Philippines
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Quezon City, 1104, Philippines
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Bialystok, 15-027, Poland
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Gdansk, 80-952, Poland
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Grudziądz, 86-300, Poland
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Koszalin, 75-581, Poland
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Krakow, 30-510, Poland
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Olsztyn, 10-228, Poland
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Ostrołęka, 07-410, Poland
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Poznan, 60-693, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 53-413, Poland
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Krasnoyarsk, 660133, Russia
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Moscow, 105077, Russia
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Nizhny Novgorod, 603074, Russia
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Novosibirsk, 630007, Russia
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Saint Petersburg, 194017, Russia
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Saint Petersburg, 194044, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 197022, Russia
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Samara, 443031, Russia
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Ufa, 450000, Russia
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Vologda, 160012, Russia
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Daegu, 41404, South Korea
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Goyang-si, 10408, South Korea
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Gyeonggi-do, 13620, South Korea
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Incheon, 21565, South Korea
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Seoul, 03080, South Korea
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Seoul, 05505, South Korea
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Seoul, 136-705, South Korea
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Badalona, 08916, Spain
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Barcelona, 08035, Spain
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Córdoba, 14004, Spain
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Las Palmas de Gran Canaria, 35016, Spain
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Madrid, 28007, Spain
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Madrid, 28041, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Kaohsiung City, 807, Taiwan
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Taichung, 404, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Tainan, 710, Taiwan
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Taipei, 10050, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan, 333, Taiwan
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Ankara, 06590, Turkey (Türkiye)
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Cordaleo, 35575, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Istanbul, 34030, Turkey (Türkiye)
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Istanbul, 34457, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Edinburgh, EH4 2XR, United Kingdom
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London, E1 1BB, United Kingdom
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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Sheffield, S10 2SJ, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hochiminh, 70000, Vietnam
Related Publications (1)
Powles T, Catto JWF, Galsky MD, Al-Ahmadie H, Meeks JJ, Nishiyama H, Vu TQ, Antonuzzo L, Wiechno P, Atduev V, Kann AG, Kim TH, Suarez C, Chang CH, Roghmann F, Ozguroglu M, Eigl BJ, Oliveira N, Buchler T, Gadot M, Zakharia Y, Armstrong J, Gupta A, Hois S, van der Heijden MS; NIAGARA Investigators. Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer. N Engl J Med. 2024 Nov 14;391(19):1773-1786. doi: 10.1056/NEJMoa2408154. Epub 2024 Sep 15.
PMID: 39282910DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2018
First Posted
November 6, 2018
Study Start
November 16, 2018
Primary Completion
April 29, 2024
Study Completion (Estimated)
June 30, 2026
Last Updated
March 13, 2026
Results First Posted
July 3, 2025
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.