A clinical trial of sac-TMT in people with urothelial cancer

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator’s Choice of Non-platinum Chemotherapy in Participants with Pretreated Locally Advanced/Metastatic Urothelial Carcinoma

• IRAS ID

  1011730

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for other ways to treat locally advanced or metastatic urothelial cancer (UC).
  Current treatments include chemotherapy, immunotherapy, and targeted therapy.
  Sacituzumab tirumotecan (known as sac-TMT or MK-2870), the trial medicine, is an antibody drug conjugate (ADC) that attaches to a specific target on cancer cells and delivers treatment to destroy those cells.
  The goal of this trial is to learn if participants who receive sac-TMT live longer overall than those who receive chemotherapy.
  About 590 participants will be in the trial. Participants will be at least 18 years old and:
  • Have received all of these either alone, together or with other treatments:
  o A certain chemotherapy
  o An immunotherapy that targets a protein found on certain immune system cells (PD-1) or a protein found on some cancer cells (PD-L1) that can help the cancer hide from the body’s immune system
  o Enfortumab vedotin, an ADC
  • Had the cancer get worse during or after their most recent treatment
  • Have not had other certain types of cancer in the past 3 years

  Participants will have an equal chance to receive one of these trial treatments:
  • Sac-TMT, the trial medicine, once every 2 weeks, until the cancer gets worse or they don’t tolerate it
  • Chemotherapy of the researcher’s choice (either docetaxel, paclitaxel, or vinflunine), once every 3 weeks, until the cancer gets worse or they don’t tolerate it
  Both the participants and the researchers will know which trial treatment they are getting (open label trial). During the trial, participants will give urine and blood samples, have tumour and imaging tests and check their heart. Participants will also have physical and eye examinations and answer questions about how they are feeling.
  Participants may be in this trial, including treatment and follow-up, for up to 2 years.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  26/NW/0001

• Date of REC Opinion

  1 Apr 2026

• REC opinion

  Further Information Favourable Opinion