Home Clinical trials For professionals Endometrium BGOG-EN24/DESTINY-Endometrial01

BGOG-EN24/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 

Open
Grade
High grade, Low grade, Other / unknown
Prior lines
1, Frontline
Histology
Endometrioid, Mucinous Serous Clear-cell Carcinocarcoma Other (bv. mixed/rare)
Phase
III
IMP
Trastuzumab Deruxtecan (T-DXd)
principal investigator
Prof. Dr. Toon Van Gorp

Treatment

Participants will be randomized 1:1:

  • ARM A: T-DXd 5.4 mg/kg IV Q3W + rilvegostomig 750 mg IV Q3
  • ARM B: T-DXd 5.4 mg/kg IV Q3W + pembrolizumab 200 mg IV Q3W 
  • ARM C: Carboplatin AUC 5, paclitaxel 175 mg/m2 and pembrolizumab 200 mg IV Q3W for 6 cycles followed by maintenance pembrolizumab 400mg IV Q6W up to 14 cycles (in total 20 cycles prembrolizumab).

 

Treatment duration

  • Arm A and Arm B are administered until disease progression, unacceptable toxicity or withdrawal of consent.
  • Arm C is administered up to 20 cycles of pembrolizumab.

 

Eligibility

Main inclusion criteria:

  • Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies are allowed except for sarcomas (carcinosarcomas are allowed)
  • Following surgery or diagnostic biopsy, participant must have primary advanced disease (Stage III/IV) or first recurrent endometrial cancer and meet at least one of the following criteria:
    • Primary Stage III (per FIGO 2023) disease with measurable disease at baseline per RECIST 1.1 based on the investigator's assessment.
    • Primary Stage IV disease (per FIGO 2023) regardless of presence of measurable disease at baseline.
    • First recurrent disease regardless of presence of measurable disease at baseline.
  • Endometrial cancer with HER2 IHC expression of 3+ or 2+ as assessed by prospective central testing.
  • Endometrial cancer that is determined pMMR by prospective central IHC testing.

Main exclusion criteria:

  • History of (non-infectious) ILD/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
  • Active primary immunodeficiency/ active infectious disease(s) 

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06989112). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.

Contact

In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be

More information on this trial (NCT06989112)