Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC (NIAGARA)
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ClinicalTrials.gov Identifier: NCT03732677 |
Recruitment Status :
Active, not recruiting
First Posted : November 6, 2018
Last Update Posted : November 9, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Muscle Invasive Bladder Cancer | Drug: Durvalumab Drug: Cisplatin Drug: Gemcitabine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1063 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer. |
Actual Study Start Date : | November 16, 2018 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | June 30, 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1
Chemotherapy + Durvalumab
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Drug: Durvalumab
Anti- PD-L1 Antibody Drug: Cisplatin Chemotherapy Agent Drug: Gemcitabine Chemotherapy agent |
Active Comparator: Arm 2
Chemotherapy alone
|
Drug: Cisplatin
Chemotherapy Agent Drug: Gemcitabine Chemotherapy agent |
- Pathologic complete response (pCR) rates at time of cystectomy [ Time Frame: Up to 6 months ]
- Event-free survival (EFS) per central review defined as time from randomization to event [ Time Frame: Up to 48 months ]
- Proportion of patients who achieve <P2 at time of cystectomy [ Time Frame: Up to 6 months ]
- EFS at 24 months (EFS24) defined as time from randomization to event [ Time Frame: Up to 24 months ]
- Proportion of patients who undergo cystectomy [ Time Frame: Up to 6 months ]
- Overall survival rate at 5 years [ Time Frame: Up to 60 months ]
- PFS2 defined as time from randomization to event following subsequent therapy [ Time Frame: Up to 84 months ]
- Safety and Tolerability as evaluated by adverse events occurring throughout the study [ Time Frame: Up to 84 months ]
- Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA) [ Time Frame: Up to 12 months ]
- Overall Survival [ Time Frame: Up to 84 months ]
- Metastasis-free survival per investigator assessment or local biopsy review. [ Time Frame: Up to 48 months ]
- Disease-specific survival per investigator assessment or local biopsy review. [ Time Frame: up to 48 months ]
- Disease-free survival [ Time Frame: Up to 48 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 130 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732677

Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT03732677 |
Other Study ID Numbers: |
D933RC00001 2018-001811-59 ( EudraCT Number ) |
First Posted: | November 6, 2018 Key Record Dates |
Last Update Posted: | November 9, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Access Criteria: | When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
URL: | https://astrazenecagroup-dt.pharmacm.com/DT/Home |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Bladder Cancer Immunotherapy PD-L1 Durvalumab (MEDI4736) |
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Gemcitabine Cisplatin Durvalumab Antineoplastic Agents |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological |