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

Sponsor
AstraZeneca
Study ID
NCT06960577
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Cisplatin
  • Doxorubicin
  • Gemcitabine
  • Immune Checkpoint Inhibitors
  • Methotrexate
  • Urinary Bladder Neoplasms
  • Vinblastine

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Anti- PD-L1 Antibody.
  • Methotrexate — DRUG
    Chemotherapy agent.
  • Vinblastine — DRUG
    Chemotherapy agent
  • Doxorubicin — DRUG
    Chemotherapy agent
  • Cisplatin — DRUG
    Chemotherapy agent
  • Durvalumab — DRUG
    Anti- PD-L1 Antibody
  • Gemcitabine — DRUG
    Chemotherapy agent
  • Cisplatin — DRUG
    Chemotherapy agent

Study Details

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.

Key Dates

Start date
May 15, 2025
Status verified
Jun 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ddMVAC cohort
    Durvalumab + chemotherapy
  • Experimental: gem/cis cohort
    Durvalumab + chemotherapy

Primary Outcome Measure

The safety of neoadjuvant durvalumab combined with ddMVAC or gem/cis prior to radical cystectomy (RC). [ Time Frame: Up to 6 months ]

Central Contacts

Related Studies