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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03732677
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Muscle Invasive Bladder Cancer Drug: Durvalumab Drug: Cisplatin Drug: Gemcitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 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 : December 18, 2025
Estimated Study Completion Date : December 18, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Arm 1
Chemotherapy + Durvalumab
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




Primary Outcome Measures :
  1. Pathologic complete response (pCR) rates at time of cystectomy [ Time Frame: Up to 6 months ]
  2. Event-free survival (EFS) per central review defined as time from randomization to event [ Time Frame: Up to 48 months ]

Secondary Outcome Measures :
  1. Proportion of patients who achieve <P2 at time of cystectomy [ Time Frame: Up to 6 months ]
  2. EFS at 24 months (EFS24) defined as time from randomization to event [ Time Frame: Up to 24 months ]
  3. Proportion of patients who undergo cystectomy [ Time Frame: Up to 6 months ]
  4. Overall survival rate at 5 years [ Time Frame: Up to 60 months ]
  5. PFS2 defined as time from randomization to event following subsequent therapy [ Time Frame: Up to 84 months ]
  6. Safety and Tolerability as evaluated by adverse events occurring throughout the study [ Time Frame: Up to 84 months ]
  7. Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA) [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Patient resectable muscle-invasive bladder cancer with clinical stage T2N0M0-T4aN0M0 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 or metastatic 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

Information from the National Library of Medicine

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


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Show Show 197 study locations
Sponsors and Collaborators
AstraZeneca
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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: July 2, 2020
Last Verified: June 2020
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Bladder Cancer
Immunotherapy
PD-L1
Durvalumab (MEDI4736)
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
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