Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC (NIAGARA)

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

Conditions: Muscle Invasive Bladder Cancer

Treatments: Drug: Cisplatin; Drug: Durvalumab; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03732677

2018-001811-59 (EudraCT Number)

2023-510015-19-00 (Registry Identifier)

D933RC00001

Details and patient eligibility

About

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

Enrollment: 1,063 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology
• Patients must be planning to undergo a radical cystectomy
• Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC
• ECOG performance status of 0 or 1
• Must have a life expectancy of at least 12 weeks at randomization

Exclusion:

• Evidence of lymph node (N2-N3) or metastatic (M1) disease at time of screening.
• Prior pelvic radiotherapy treatment within 2 years of randomization to study
• Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies.
• Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
• Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
• Uncontrolled intercurrent illness
• Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,063 participants in 2 patient groups

Arm 1

Experimental group

Description:

Chemotherapy + Durvalumab

Treatment:

Drug: Gemcitabine

Drug: Cisplatin

Drug: Durvalumab

Arm 2

Active Comparator group

Description:

Chemotherapy alone

Treatment:

Drug: Gemcitabine

Drug: Cisplatin