Home Clinical trials For patients Uterus 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
Trial drug
Trastuzumab Deruxtecan (T-DXd)
Grade
High grade, Low grade, Other / unknown
Prior lines
1, Frontline
Histology
Endometrioid, Mucinous Serous Clear-cell Carcinocarcoma Other (bv. mixed/rare)
Phase
III

Treatment

Participants will be randomized 1:1:

  • ARM A: T-DXd 5.4 mg/kg IV Q3W + rilvegostomig 750 mg IV Q3W 

  • 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.

 

Contact

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