DESTINY-Endometrial01

• Research type

  Research Study

• Full title

  DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer

• IRAS ID

  1011715

• Contact name

  Emmanuel Amadi

• Contact email

  UKRegulatoryAffairs@astrazeneca.com

• Eudract number

  2023-508056-19

• Research summary

  Researchers are looking for a better way to treat advanced or recurrent HER2-expressing, pMMR endometrial cancer. In people with endometrial cancer, the body is not able to control the growth of some cells in the endometrium (the lining of the uterus). The extra cells can form tumours, which can affect the normal function of the body.
  Advanced means that the cancer has spread from where it started to other parts of the body and cannot be treated with surgery. Recurrent means that the cancer has come back after receiving a previous treatment. HER2-expressing means that their cancer has high levels of a protein called HER2. High levels of the HER2 protein can cause the tumour to grow and spread more quickly. pMMR means that a person has a normally functioning mismatch repair (MMR) system. The MMR system helps to keep DNA stable and prevents cells from changing or becoming cancerous.
  Chemotherapy with immunotherapy is a standard treatment for endometrial cancer in some countries. Immunotherapy is a cancer treatment designed to help the immune cells to stop tumours from growing. Rilvegostomig and pembrolizumab are types of immunotherapies.
  Trastuzumab deruxtecan (T-DXd) is designed to kill tumour cells that have the HER2 protein. In this trial, researchers want to learn how well T-DXd combined with immunotherapy works compared to chemotherapy and immunotherapy in adults with advanced or recurrent HER2- expressing, pMMR endometrial cancer.
  600 participants will be split into 3 treatment groups: Group 1 will receive T-DXd with rilvegostomig, Group 2 will receive T-DXd with pembrolizumab, and Group 3 will receive chemotherapy with pembrolizumab. Group 1 and 2 participants will receive treatment every 3 weeks as long as it safe and effective. Group 3 participants will receive chemotherapy with pembrolizumab for about 6 months, followed by pembrolizumab alone for an additional 1.5 years

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  25/NW/0050

• Date of REC Opinion

  7 May 2025

• REC opinion

  Further Information Favourable Opinion