WO42178-Evaluating Biomarker Driven Therapies in Rare Ovarian Tumours

• Research type

  Research Study

• Full title

  A PHASE II, OPEN-LABEL, MULTICENTER, PLATFORM STUDY EVALUATING THE EFFICACY AND SAFETY OF BIOMARKER-DRIVEN THERAPIES IN PATIENTS WITH PERSISTENT OR RECURRENT RARE EPITHELIAL OVARIAN TUMORS

• IRAS ID

  1003682

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2020-004936-72

• Clinicaltrials.gov Identifier

  NCT04931342

• Research summary

  Ovarian cancer is the 8th most commonly diagnosed cancer among women worldwide and is the 2nd most common cause of death attributed to gynaecological cancer. The majority of women diagnosed will die as a result of their disease.
  Various studies have highlighted the significant unmet need for treatment for rare ovarian cancer. Improved understanding of the role of cancer biomarkers, further development of molecularly targeted therapies, and the standardization of targeted treatments into treatment guidelines have shifted clinical practice to utilize genomic information as an integral component of clinical decision-making.
  The purpose of this study is to assess the effects, of biomarker-driven drug therapies on patients who have rare ovarian cancer with specific genetic alterations. Patients will undergo biomarker and pathology eligibility testing, and based on the biomarkers present in their tumour, will be assigned to a treatment groups after some initial tests to ensure they are suitable to participate.
  The groups are:
  1. Ipatasertib + paclitaxel (Ipat + Pac): Ipatasertib tablet taken orally on Days 1–21 of each 28-day cycle. Paclitaxel will be administered into a vein on Days 1, 8, and 15 of each 28-day cycle
  2. Cobimetinib (Cobi): Cobimetinib is a tablet taken orally on Days 1–21 of a 28-day cycle
  3. Trastuzumab emtansine (T-DM1): Administered into a vein on Day 1 of a 21-day cycle.
  4. Atezolizumab + bevacizumab (Atezo + Bev): Atezolizumab administered into a vein on Day 1 of each 21-day cycle. Bevacizumab administered into a vein on Day 1 of each 21-day cycle.
  Patients will take study treatment on a regular basis until disease progression after which they will followed up every 3 months. The total time in the study will depend on how the patient’s cancer responds to treatment and could range from 1 day to several years. Between 80-200 patients will be enrolled worldwide. 4 in the UK
  Sponsored by F. Hoffman La Roche. Summary; V1.0 dated 23 Feb 2021

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  21/SC/0109

• Date of REC Opinion

  3 Jun 2021

• REC opinion

  Further Information Favourable Opinion