Clinical trial · Interventional
Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
A Phase IIIb, Open-label, Single-arm, Global Study of Perioperative Durvalumab With Neoadjuvant ddMVAC or Gem/Cis in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)
NCT06960577CI-TRIAL-00120439recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cisplatin | — | UNRESOLVED | — |
| Doxorubicin | — | UNRESOLVED | — |
| Gemcitabine | — | UNRESOLVED | — |
| Immune Checkpoint Inhibitors | — | UNRESOLVED | — |
| Methotrexate | — | UNRESOLVED | — |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
| Vinblastine | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ddMVAC cohort
- description
- Durvalumab + chemotherapy
- interventionNames
- Drug: Durvalumab
- Drug: Methotrexate
- Drug: Vinblastine
- Drug: Doxorubicin
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- gem/cis cohort
- description
- Durvalumab + chemotherapy
- interventionNames
- Drug: Durvalumab
- Drug: Gemcitabine
- Drug: Cisplatin
Primary outcomes (1)
- measure
- The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with clinical tumour stage T2-T4aN0/1M0 or T1N1M0 with transitional or mixed transitional cell histology * Patients must be planning to undergo radical cystectomy * Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer * ECOG performance status of 0 or 1 * Minimum life expectancy of 12 weeks at first dose of study medication Exclusion criteria: * Evidence of lymph node (N2-N3) or metastatic (M1) disease * Inoperable tumour(s) with fixation to the pelvic wall on clinical examination * Prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD 1, anti-PD L1 and anti-PD-L2 antibodies, excluding Bacillus Calmette-Guérin * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab * Any concomitant medication known to be contraindicated to the chemotherapy (ddMVAC or gem/cis). * Uncontrolled intercurrent illness.
References
Publications (0)
Data not yet available
No reference posted for this study.