MK2870±Pembro vs TPC in 1L unresectable/metastatic TNBC (PD-L1 CPS<10)

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT, MK-2870) as a Monotherapy and in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less than 10 (TroFuse-011)

• IRAS ID

  1010956

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for new ways to treat PD-L1 negative triple negative breast cancer (TNBC). PD-L1 (a protein) found on cancer cells can help the cancer hide from the immune system. PD-L1 negative means the cancer has very little or no PD-L1 protein. TNBC (a breast cancer type) grows fast and is hard to treat. It is called triple negative because the cancer cells do not have receptors (proteins) for oestrogen, progesterone, or human epidermal growth factor 2 (HER2).
  Standard treatment for PD-L1 negative TNBC uses chemotherapy (medicine) to destroy cancer cells or stop them growing. However, the cancer may not respond (get smaller or go away).

  Sacituzumab tirumotecan (sac-TMT or MK-2870) and pembrolizumab are trial medicines. Sac-TMT is an antibody-drug conjugate (ADC) which attaches to a protein on cancer cells and delivers treatment to destroy those cells. Pembrolizumab (an immunotherapy) helps the immune system fight cancer.
  The main trial goal is to learn if people treated with sac-TMT alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to chemotherapy.

  About 1,000 participants at least 18 years old with PD-L1 negative TNBC will be in this trial. They will have cancer that has come back after treatment and cannot be removed by surgery, or cancer that has spread to other parts of the body and will have not received certain other treatments.

  Participants may receive pembrolizumab (up to 2 years), sac-TMT or chemotherapy into a vein as an intravenous (IV) infusion until their cancer grows or spreads, they or researcher decide to stop, they do not tolerate it, or trial ends.
  
  Participants will be randomly assigned to 1 of these treatment groups:
  • Group A: sac-TMT alone
  • Group B: sac-TMT with pembrolizumab
  • Group C: chemotherapy

  Participants may be in this trial for 5.5 years.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  25/SC/0039

• Date of REC Opinion

  13 Mar 2025

• REC opinion

  Further Information Favourable Opinion