hARnessing CAbozantinib and Durvalumab Immuno-oncology Association: ARCADIA Study"

Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study ID
NCT03824691
Phase
PHASE2
Status
Unknown

Conditions

  • Bladder Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    cabozantinib 40 mg orally once daily
  • Durvalumab — DRUG
    1500 mg durvalumab (MEDI4736) IV infusion every 28 days

Study Details

Cabozantinib plus Durvalumab in patients with advanced and chemotherapy-treated bladder carcinoma, of urothelial and non-urothelial histology: an open-label, single-centre, phase 2, single-arm proof-of-concept trial: ARCADIA study

Key Dates

Start date
Sep 25, 2019
Status verified
Feb 2021
Primary completion
Feb 28, 2023
Completion
Feb 28, 2023

Study Design

Enrollment
122 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib + Durvalumab
    Subjects will receive 1500 mg durvalumab (MEDI4736) IV infusion every 28 days + Cabozantinib 40 mg orally once daily

Primary Outcome Measure

The primary endpoint of the study will be overall survival (OS). [ Time Frame: 48 months ]

Central Contacts

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