Phase 3 study of MK-5684 versus alternative NHA in mCRPC

• Research type

  Research Study

• Full title

  MK-5684-003: A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)

• IRAS ID

  1008710

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06136624

• Research summary

  Researchers are looking for other ways to treat people with a type of prostate cancer called metastatic castration-resistant prostate cancer (mCRPC). In mCRPC, the cancer has spread to other parts of the body and got worse or came back after standard hormone therapy. Standard hormone therapy is treatment to lower the level of certain hormones in the body to slow the growth and spread of cancer cells. Newer types of hormone therapy to treat mCRPC are called next-generation hormonal agents (NHA).

  MK-5684 is a trial medicine designed to treat mCRPC by blocking the body from making steroid hormones. Researchers will give MK-5684 with hormone replacement therapy (HRT) because the body needs certain steroid hormones to control body functions.

  The goal of this trial is to learn if people who take MK-5684 live longer overall and without the cancer getting worse compared to people who take NHA.

  About 1,200 participants with mCRPC will be in this trial. They will be at least 18 years old and:
  • Have had the cancer get worse during or after treatment with one NHA
  • Have had the cancer get worse during or after treatment with one previous chemotherapy for mCRPC.
  • Do not have other certain health conditions

  Participants will have an equal chance of taking one of these treatments by mouth as tablets:
  • MK-5684 with HRT (dexamethasone and fludrocortisone)
  • NHA, either:
  o Abiraterone acetate and prednisone
  o Enzalutamide

  Participants may take MK-5684 or prednisone twice a day. All other treatments will be taken once a day. Participants will continue their treatment until the cancer gets worse or the participant cannot tolerate treatment.

  During the trial, participants will give urine and blood samples, have imaging tests, physical examinations and answer questions about how they are feeling and their ability to carry out daily tasks.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  23/LO/0946

• Date of REC Opinion

  7 Feb 2024

• REC opinion

  Further Information Favourable Opinion