Ph1b/2 Study of R-DXd With/Without Anticancer Agents in Ovarian Cancer

• Research type

  Research Study

• Full title

  A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants With High-grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Relapsed After Prior Platinum-based Chemotherapy

• IRAS ID

  1010808

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  This trial is testing MK-5909 (raludotatug deruxtecan (R-DXd)) in people with certain types of ovarian cancer. It is testing R-DXd when given in combination with standard treatments (carboplatin, paclitaxel, or bevacizumab) for ovarian cancer. R-DXd is a type of drug called an antibody drug conjugate (ADC). ADCs are made to attach to tumour cells to deliver chemotherapy directly to tumour cells and not healthy cells. In this trial, the target for R-DXd is Cadherin 6 (CDH6). R-DXd specifically binds to tumour cells that are expressing CDH6 and kill the tumour cells by releasing drug into the cells.

  The goal of this study is to:
  • Test the safety of the trial drug combinations
  • See how well the trial drug combinations work

  About 78 people (18 years and over) whose ovarian cancer has come back after earlier treatment and whose previous treatment included a type of chemotherapy, called platinum-based chemotherapy will take part.

  People will be assigned to one of these treatment groups:
  • Group 1: R-DXd with carboplatin
  • Group 2: R-DXd with paclitaxel
  • Group 3: R-DXd with bevacizumab

  This will depend on how quickly their cancer came back after they received their last platinum-based chemotherapy treatment. Group 1 or 2 if it took 6 months or more. Group 3 if it took less than 6 months. The participant, trial doctor, and the trial staff will know what group they are in.

  The trial drugs will be given every 3 weeks by intravenous infusion.

  There will be 28-day screening period, a treatment period that will continue for as long as their cancer does not get worse, and they tolerate the trial drugs and a follow up period with about 1 or 2 follow-up visits after they stop getting the trial drugs. There may be additional follow-up visits once every 6 or 12 weeks, depending on how long they have been in the trial.

  People will be in this trial for about 3 years.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  25/LO/0209

• Date of REC Opinion

  14 May 2025

• REC opinion

  Further Information Favourable Opinion