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

NCT03732677

Description:

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

Related Conditions:
  • Infiltrating Bladder Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
  • 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

Clinical Trial IDs

  • ORG STUDY ID: D933RC00001
  • SECONDARY ID: 2018-001811-59
  • NCT ID: NCT03732677

Conditions

  • Muscle Invasive Bladder Cancer

Interventions

DrugSynonymsArms
DurvalumabArm 1
CisplatinArm 1
GemcitabineArm 1

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm 1ExperimentalChemotherapy + Durvalumab
  • Durvalumab
  • Cisplatin
  • Gemcitabine
Arm 2Active ComparatorChemotherapy alone
  • Cisplatin
  • Gemcitabine

Eligibility Criteria

        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
      
Maximum Eligible Age:130 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathologic complete response (pCR) rates at time of cystectomy following neoadjuvant treatment, as assessed by central pathology review
Time Frame:Up to 6 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Proportion of patients who undergo cystectomy
Time Frame:Up to 6 months
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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 Issue:
Description:
Measure:Safety and Tolerability as evaluated by adverse events occurring throughout the study
Time Frame:Up to 84 months
Safety Issue:
Description:
Measure:Immunogenicity of durvalumab when used in combination with gemcitabine/cisplatin as measured by presence of antidrug antibodies (ADA)
Time Frame:Up to 12 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • Bladder Cancer
  • Immunotherapy
  • PD-L1
  • Durvalumab (MEDI4736)

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