MK-2870 Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery

• IRAS ID

  1009532

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06393374

• Research summary

  Researchers are looking for other ways to treat triple-negative breast cancer (TNBC). MK-2870 and pembrolizumab are the trial medicines. MK-2870 is a type of targeted therapy which is a treatment that works to control how specific types of cancer cells grow and spread. Researchers want to know if giving MK-2870 and pembrolizumab after surgery can treat people with TNBC that didn’t respond to neoadjuvant treatment.

  About 1,530 people with TNBC, aged 18+ years will participate and:
  • Had at least 5 treatments of pembrolizumab and chemotherapy as neoadjuvant treatment
  • Had surgery to remove the TNBC
  • Had signs of cancer cells in tissues removed during surgery, meaning they didn’t respond to neoadjuvant treatment
  • Don’t have heart disease or disease of blood vessels in the brain

  People will have an equal chance to be assigned to 1 of 2 groups:
  • Group A: MK-2870 and pembrolizumab
  • Group B: the researcher’s choice of either:
  • Pembrolizumab alone
  • Pembrolizumab with chemotherapy

  People will receive:
  • MK-2870, given through a needle into a vein as an intravenous (IV) infusion every 2 weeks
  • Pembrolizumab, given as an IV infusion every 6 weeks
  • Chemotherapy, taken by mouth as a tablet twice a day for 2 out of every 3 weeks

  People will continue treatment for about 6 months unless the cancer gets worse or the person doesn’t tolerate treatment. Both the people in the trial and the researcher will know which treatment a person is getting (open-label trial). During the trial, people will give urine and blood samples, have tumour and imaging tests, physical examinations, and a test to measure the heart’s electrical activity, and answer questions about how they are feeling and their ability to carry out daily tasks.
  A person may be in this trial and followed for up to 10 years.

• REC name

  Wales REC 1

• REC reference

  24/WA/0129

• Date of REC Opinion

  8 Jul 2024

• REC opinion

  Further Information Favourable Opinion