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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT03732677
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Muscle Invasive Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Anti- PD-L1 Antibody
  • Cisplatin — DRUG
    Chemotherapy Agent
  • Gemcitabine — DRUG
    Chemotherapy agent

Study Details

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

Key Dates

Start date
Nov 16, 2018
Status verified
Feb 2026
Primary completion
Apr 29, 2024
Completion
Jun 30, 2026

Study Design

Enrollment
1,063 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Chemotherapy + Durvalumab
  • Active Comparator: Arm 2
    Chemotherapy alone

Primary Outcome Measure

Pathologic Complete Response (pCR) Rates at Time of Cystectomy [ Time Frame: Up to 6 months ]

Locations (18)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35294-
Research SiteLos AngelesCalifornia90095-
Research SitePalo AltoCalifornia94304-
Research SiteNew HavenConnecticut06520-
Research SiteChicagoIllinois60611-
Research SiteGenevaIllinois60134-
Research SiteIowa CityIowa52242-
Research SiteWestwoodKansas66205-
Research SiteLouisvilleKentucky40202-
Research SiteNew OrleansLouisiana70112-
Research SiteTowsonMaryland21204-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48201-
Research SiteNew YorkNew York10029-
Research SiteRochesterNew York14642-
Research SiteBethlehemPennsylvania18015-
Research SiteBurlingtonVermont05401-
Research SiteMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
Research Site· Birmingham, ALResearch Site· Los Angeles, CAResearch Site· Palo Alto, CAResearch Site· New Haven, CTResearch Site· Chicago, ILResearch Site· Geneva, IL

Related Studies