OncoMatch/Clinical Trials/NCT06960577
Perioperative Durvalumab With Neoadjuvant ddMVAC in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)
Official title: An Open-label, Single-arm, Global Study of Perioperative Durvalumab With Cisplatin-based Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)
Is NCT06960577 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments for urinary bladder neoplasms.
Treatment: Durvalumab · Methotrexate · Vinblastine · Doxorubicin · Cisplatin · Gemcitabine — The Phase II NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with cisplatin based neoadjuvant chemotherapy in a clinical practice setting.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage T2N0M0, T2N1M0, T3N0M0, T3N1M0, T4AN0M0, T4AN1M0, T1N1M0 (other)
clinical tumour stage T2-T4aN0/1M0 or T1N1M0; Evidence of lymph node (N2-N3) or metastatic (M1) disease
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy for muscle-invasive bladder cancer
Participants who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer
Cannot have received: immunotherapy for muscle-invasive bladder cancer
Participants who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer
Cannot have received: immune-mediated therapy
Exception: excluding Bacillus Calmette-Guérin
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06960577 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage T2N0M0 or T2N1M0 or T3N0M0 or T3N1M0 or T4AN0M0 or T4AN1M0 or T1N1M0 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages