A Phase 3 interventional study of Durvalumab and Methotrexate in Urinary Bladder Neoplasms, Immune Checkpoint Inhibitors and Methotrexate, sponsored by AstraZeneca. Recruiting at 59 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The Phase IIIb NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with investigator-selected cisplatin-based neoadjuvant chemotherapy (either ddMVAC or gemcitabine/cisplatin) in a clinical practice setting.
Not provided
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Durvalumab + chemotherapy
Drug: Durvalumab · Drug: Methotrexate · Drug: Vinblastine · Drug: Doxorubicin · Drug: Cisplatin
Durvalumab + chemotherapy
Drug: Durvalumab · Drug: Gemcitabine · Drug: Cisplatin
Anti- PD-L1 Antibody.
Chemotherapy agent.
Chemotherapy agent
Chemotherapy agent
Chemotherapy agent
Anti- PD-L1 Antibody
Chemotherapy agent
Chemotherapy agent
The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC).
Incidence of Grade 3 or 4 \[possibly treatment-related adverse events (PRAEs)\] as observed prior to RC.
Time frame: Up to 6 months
The safety and tolerability of perioperative durvalumab combined with ddMVAC or gem/cis.
Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of treatment-emergent adverse events, including PRAEs, adverse events of special interest, immune-mediated adverse events, adverse events (AEs), and serious adverse events; AEs resulting in study treatment interruption and discontinuation; laboratory findings.
Time frame: Up to 2 years
The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of event-free survival (EFS).
EFS is defined as the time from first neoadjuvant durvalumab + chemotherapy treatment until the earliest occurrence of any of the following events: * First recurrence of disease after RC * First documented progression in participants who were medically precluded from RC * Time of expected surgery in participants who refuse to undergo RC or failure to undergo RC in participants with residual disease * Death due to any cause.
Time frame: Up to 3 years
The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of disease-free survival (DFS).
DFS is defined as the time from the date of RC to the earliest of the first recurrence of disease post RC or death due to any cause.
Time frame: Up to 3 years
The efficacy of perioperative durvalumab combined with ddMVAC or gem/cis in terms of OS.
OS is defined as the time from first neoadjuvant durvalumab + chemotherapy until death due to any cause.
Time frame: Up to 3 years
The efficacy of neoadjuvant durvalumab combined with ddMVAC or gem/cis followed by RC in terms of pathologic complete response (pCR).
pCR rate is defined as the proportion of participants whose pathologic staging is T0N0M0 as assessed per local pathology review using specimens obtained via RC.
Time frame: Up to 3 years
The efficacy of neoadjuvant durvalumab combined with ddMVAC or gem/cis followed by RC in terms of pathologic downstaging (pDS).
pDS rate is defined as the proportion of participants whose pathologic staging is \<P2 per local pathology review using specimens obtained via RC.
Time frame: Up to 3 years
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap
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