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

AstraZeneca

Status and phase: Not yet enrolling; Phase 3

Conditions: Methotrexate; Immune Checkpoint Inhibitors; Urinary Bladder Neoplasms; Vinblastine; Gemcitabine; Cisplatin; Doxorubicin

Treatments: Drug: Durvalumab; Drug: Cisplatin; Drug: Doxorubicin; Drug: Gemcitabine; Drug: Vinblastine; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT06960577

D933RC00002

Details and patient eligibility

About

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.

Full description

Not provided

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

ddMVAC cohort

Experimental group

Description:

Durvalumab + chemotherapy

Treatment:

Drug: Methotrexate

Drug: Vinblastine

Drug: Doxorubicin

Drug: Durvalumab

Drug: Cisplatin

Drug: Durvalumab

Drug: Cisplatin

gem/cis cohort

Experimental group

Description:

Durvalumab + chemotherapy

Treatment:

Drug: Gemcitabine

Drug: Durvalumab

Drug: Cisplatin

Drug: Durvalumab

Drug: Cisplatin