A Multicentre Phase II Trial of Durvalumab Versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinomas

Sponsor
National University Hospital, Singapore
Study ID
NCT03405454
Phase
PHASE2
Status
Unknown

Conditions

  • Ovarian Clear Cell Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • durvalumab — DRUG
    Durvalumab will be given at 1500mg fixed dose every 4 weeks for 24 months or until the appearance of significant treatment-related toxicity or disease progression
  • standard chemotherapy — DRUG
    chemotherapy treatment will be administered as per local institutional guidelines

Study Details

The purpose of this study is to find out if treatment with a study drug, durvalumab has beneficial effects in people who have recurrent ovarian clear cell cancer and to determine what effects (both good and bad) it has on them and their cancer.

Key Dates

Start date
Oct 9, 2017
Status verified
Mar 2018
Primary completion
Sep 15, 2021
Completion
Mar 15, 2022

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: standard chemotherapy
    Patients on physician's choice of chemotherapy are allowed to receive any systemic chemotherapy either as a single agent or in combination. However, biologics( including bevacizumab) and oral tyrosine kinase inhibitors will not be allowed for patients on this arm
  • Experimental: durvalumab
    Patients on durvalumab will be given at 1500mg fixed dose every 4 weeks for 24 months

Primary Outcome Measure

Progression free survival [ Time Frame: 4 years ]

Central Contacts

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