Clinical Trials /

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:
  • Bladder Mixed Adenocarcinoma
  • 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 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
      
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
Time Frame:Up to 6 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Proportion of patients who achieve <P2 at time of cystectomy
Time Frame:Up to 6 months
Safety Issue:
Description:
Measure:EFS at 24 months (EFS24) defined as time from randomization to event
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
Time Frame:Up to 60 months
Safety Issue:
Description:
Measure:PFS2 defined as time from randomization to event following subsequent therapy
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)

Last Updated

February 6, 2020