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OncoMatch/Clinical Trials/NCT06960577

Perioperative Durvalumab With Neoadjuvant ddMVAC or Gemcitabine/Cisplatin in Patients With Muscle-invasive Bladder Cancer (NIAGARA-2)

Is NCT06960577 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for urinary bladder neoplasms.

Phase 3RecruitingAstraZenecaNCT06960577Data as of May 2026

Treatment: Durvalumab · Methotrexate · Vinblastine · Doxorubicin · Cisplatin · Durvalumab · Gemcitabine · CisplatinThe 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.

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Disease stage

Required: Stage T2N0M0, T2N1M0, T3N0M0, T3N1M0, T4AN0M0, T4AN1M0, T1N1M0 (TNM)

clinical tumour stage T2-T4aN0/1M0 or T1N1M0; Evidence of lymph node (N2-N3) or metastatic (M1) disease [excluded]

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic chemotherapy

Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of muscle-invasive bladder cancer

Cannot have received: immunotherapy

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.

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