DOMENICA

• Research type

  Research Study

• Full title

  DOMENICA (GINECO-EN105b/ENGOT-en13 study) Randomized phase III trial in MMR deficient endometrial cancer patients comparing chemotherapy alone versus Dostarlimab in first line advanced/metastatic setting.

• IRAS ID

  1006901

• Contact name

  Sebastien Armanet

• Contact email

  reglementaire@arcagy.org

• Sponsor organisation

  ARCAGY-GINECO

• Eudract number

  2021-002124-21

• ISRCTN Number

  ISRCTN16573769

• Clinicaltrials.gov Identifier

  NCT05201547

• Research summary

  The DOMENICA study aims to evaluate the effectiveness of dostarlimab, as a new treatment for advanced/metastatic endometrial cancer by significantly reducing the chance of relapse.
  Dostarlimab is a type of immunotherapy (doesn’t target the tumour directly, but has an impact on the immune system to be able to attack and destroy the cancer cells). When the immune system detects a foreign body (virus, bacteria, etc), it produces antibodies which are proteins that combat infections. They can attach to other molecules or cells of your body, and work by helping your immune system to fight the cancer.
  The current standard treatment for this cancer is chemotherapy alone (Paclitaxel and Carboplatin). Despite chemotherapy, the cancer can progress in some patients.

  The study will be carried out among 142 patients with advanced or metastatic endometrial cancer, in more than 60 healthcare facilities in 7 countries (France, Belgium, Spain, Italy, Germany, Canada and United Kingdom) over an 8 year period.
  In order to evaluate the efficacy of dostarlimab, it is necessary to compare this treatment to the standard treatment. In order to be able to make comparisons, it is necessary that the distribution between the 2 groups is randomly selected by a computer (this is called randomization). There will be the same number of patients in each treatment group therefore patients have 1 possibility out of 2 to receive dostarlimab.

  The duration of participation in this research study for each patient is around 5 years. Participation will be divided into 5 periods:
  • Collection of a tumour sample (standard of care, not an extra procedure),
  • Ensuring the criteria for inclusion is met,
  • Allocation of treatment,
  • Treatment period,
  • Follow up period.
  Participants will have the right to withdraw at any point and treatment will not be compromised.

  If successful this study could help patients get quicker access to the therapeutic innovation, especially immunotherapy.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  23/EM/0142

• Date of REC Opinion

  20 Nov 2023

• REC opinion

  Further Information Favourable Opinion