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

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ClinicalTrials.gov Identifier: NCT03732677
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 5, 2018
First Posted Date  ICMJE November 6, 2018
Last Update Posted Date September 30, 2019
Actual Study Start Date  ICMJE November 16, 2018
Estimated Primary Completion Date December 18, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Pathologic complete response (pCR) rates at time of cystectomy following neoadjuvant treatment, as assessed by central pathology review [ Time Frame: Up to 6 months ]
  • Event-free survival (EFS) per central review defined as time from randomization to the first recurrence of disease (after cystectomy), or progression in patients who were precluded for cystectomy, or death due to any cause, whichever occurs first [ Time Frame: Up to 48 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • Pathologic complete response (pCR) rates at time of cystectomy following neoadjuvant treatment, as assessed by central pathology review [ Time Frame: Up to 36 months ]
  • Event-free survival (EFS) per central review defined as time from randomization to the first recurrence of disease (after cystectomy), or progression in patients who were precluded for cystectomy, or death due to any cause, whichever occurs first [ Time Frame: Up to 48 months ]
Change History Complete list of historical versions of study NCT03732677 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Proportion of patients who achieve <P2 (Pa,P1 and Cis) at time of cystectomy following neoadjuvant treatment, as assessed by central pathology review [ Time Frame: Up to 6 months ]
  • EFS at 24 months (EFS24) defined as time from randomization to the first recurrence of disease (after cystectomy), or first progression in patients who were precluded for cystectomy, or death due to any cause, whichever occurs first [ Time Frame: Up to 24 months ]
  • Proportion of patients who undergo cystectomy [ Time Frame: Up to 6 months ]
  • Overall survival rate at 5 years, as determined based on time from date of randomization to date of death, from any cause [ Time Frame: Up to 60 months ]
  • PFS2 defined as the time from the date of randomization to the earliest date of progression which occurs on subsequent therapy following an EFS event or death [ 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • Proportion of patients who achieve <P2 (Pa,P1 and Cis) at time of cystectomy following neoadjuvant treatment, as assessed by central pathology review [ Time Frame: Up to 36 months ]
  • EFS at 24 months (EFS24) defined as time from randomization to the first recurrence of disease (after cystectomy), or first progression in patients who were precluded for cystectomy, or death due to any cause, whichever occurs first [ Time Frame: Up to 24 months ]
  • Proportion of patients who undergo cystectomy [ Time Frame: Up to 36 months ]
  • Overall survival rate at 5 years, as determined based on time from date of randomization to date of death, from any cause [ 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Muscle Invasive Bladder Cancer
Intervention  ICMJE
  • Drug: Durvalumab
    Anti- PD-L1 Antibody
  • Drug: Cisplatin
    Chemotherapy Agent
  • Drug: Gemcitabine
    Chemotherapy agent
Study Arms  ICMJE
  • Experimental: Arm 1
    Chemotherapy + Durvalumab
    Interventions:
    • Drug: Durvalumab
    • Drug: Cisplatin
    • Drug: Gemcitabine
  • Active Comparator: Arm 2
    Chemotherapy alone
    Interventions:
    • Drug: Cisplatin
    • Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2018)
1050
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 18, 2025
Estimated Primary Completion Date December 18, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion:

  • Patient resectable muscle-invasive bladder cancer with clinical stage T2N0M0-T4aN0M0 with transitional cell histology
  • Patients must be planning to undergo a radical cystectomy at the time of randomization
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   Chile,   Czechia,   France,   Germany,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Philippines,   Poland,   Russian Federation,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03732677
Other Study ID Numbers  ICMJE D933RC00001
2018-001811-59 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP