This is a 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 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. - NIAGARA

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001811-59-IT

Enrollment

1050

Registered

2021-06-15

Start date

2019-10-29

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with histologically or cytologically documented muscle-invasive transitional cell carcinoma (TCC) of the bladder. MedDRA version: 21.0 Level: PT Classification code 10005010 Term: Bladder cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10005011 Term: Bladder cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and poly

Interventions

Product Name: Durvalumab Product Code: [MEDI4736] Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Durvalumab CAS Number: 1428935-60-7 Current Sponsor code: MEDI4736 Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 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 at enrollment. Availability of tumor sample prior to study entry; Must have a life expectancy of at least 12 weeks at randomization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 525 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 525

Exclusion criteria

Exclusion criteria: Evidence of lymph node (N2-N3) involvement or metastatic (M1) disease at the time of screening. Contra-indication to any of the study drugs Requires immunosuppression medication for a concomitant condition Active or prior documented autoimmune or inflammatory disorders

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess efficacy of investigational product in patients with MIBC using pCR and EFS;Secondary Objective: To assess efficacy and safety of investigational product in patients with MIBC using the following: EFS, pCR, EFS24 Proportion of patients who achieve <P2 Proportion of subjects with cystectomy Metastasis-free survival and disease-specific survival OS DFS Pharmacokinetic and Immunogenicity Safety and tolerability profile;Primary end point(s): pCR EFS;Timepoint(s) of evaluation of this end point: Approximately 6 months (pCR) Up to 48 months (EFS)	—

Measure

Time frame

Main Objective: To assess efficacy of investigational product in patients with MIBC using pCR and EFS;Secondary Objective: To assess efficacy and safety of investigational product in patients with MIBC using the following: EFS, pCR, EFS24 Proportion of patients who achieve <P2 Proportion of subjects with cystectomy Metastasis-free survival and disease-specific survival OS DFS Pharmacokinetic and Immunogenicity Safety and tolerability profile;Primary end point(s): pCR EFS;Timepoint(s) of evaluation of this end point: Approximately 6 months (pCR) Up to 48 months (EFS)

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Secondary

Measure	Time frame
Secondary end point(s): EFS, pCR, EFS24 Proportion of patients who achieve <P2 Proportion of subjects with cystectomy Metastasis-free survival and disease-specific survival OS DFS Pharmacokinetic and Immunogenicity Safety and tolerability profile;Timepoint(s) of evaluation of this end point: Approximately 6 months (pCR; Proportion of patients who achieve <P2) Up to 24 months (EFS24) Up to 84 months (OS; Safety and tolerability profile) Up to 48 months (Other endpoints)	—

Measure

Time frame

Secondary end point(s): EFS, pCR, EFS24 Proportion of patients who achieve <P2 Proportion of subjects with cystectomy Metastasis-free survival and disease-specific survival OS DFS Pharmacokinetic and Immunogenicity Safety and tolerability profile;Timepoint(s) of evaluation of this end point: Approximately 6 months (pCR; Proportion of patients who achieve <P2) Up to 24 months (EFS24) Up to 84 months (OS; Safety and tolerability profile) Up to 48 months (Other endpoints)

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Countries

Australia, Belgium, Canada, Chile, Czechia, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Philippines, Poland, Russian Federation, Spain, Taiwan, Turkey, United Kingdom, United States, Vietnam

Contacts

Public ContactInformation Center

Astrazeneca

information.center@astrazeneca.com+13028851180

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026