*Substudy 01A of MK-5684-based Investigational Treatments in mCRPC

• Research type

  Research Study

• Full title

  MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

• IRAS ID

  1009170

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06353386

• Research summary

  This trial is testing MK-5684 in people with 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.

  Current treatments for mCRPC are targeted therapy and chemotherapy.

  Researchers want to know if MK-5684 (the trial medicine) when taken alone or given with different treatments can help treat mCRPC. MK-5684 is experimental and not approved to treat any type of cancer. MK-5684 blocks the body from making steroid hormones. Researchers will give MK-5684 with hormone replacement therapy (HRT).

  Up to 220 people with mCRPC will take part. They will be at least 18 years old and:
  • Have been treated with 1 or 2 next-generation hormonal agent’s (NHA).
  • Had the cancer get worse during or after the most recent NHA treatment
  • Had the cancer get worse during or after treatment
  • Do not have certain heart problems
  • Been treated with at least 2 lines of standard of care regimens

  The trial involves 4 arms, but UK participants are not eligible for Arm 3.
  Arm 1 – MK-5684 alone
  Arm 2 – MK-5684 and olaparib – a targeted therapy
  Arm 4 – MK-5684 and cabazitaxel – a chemotherapy

  MK-5684 and olaparib are taken twice a day by mouth as a tablet. People will receive chemotherapy once every 3 weeks through a needle into a vein as an intravenous (IV) infusion for up to 10 infusions. People will continue their treatment until the cancer gets worse or the person doesn’t tolerate it.

  Both the people in the trial and the researcher will know which trial treatment a person is getting. During the trial, people will give urine, blood, and tumour samples, have imaging tests, physical examinations, and answer questions about how they feel.

  A person may be in this trial for about 4 years.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  24/NW/0103

• Date of REC Opinion

  29 May 2024

• REC opinion

  Further Information Favourable Opinion