MK-2870 vs TPC in Advanced/Metastatic Gastroesophageal Adenocarcinoma

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Open-label, Randomized Study to Compare the Efficacy and Safety of MK-2870 Versus Treatment of Physician’s Choice in 3L+ Advanced/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma)

• IRAS ID

  1009498

• Contact name

  andrew aungiers

• Contact email

  andrew.aungiers@msd.com

• Clinicaltrials.gov Identifier

  NCT06356311

• Research summary

  Researchers are looking for new ways to treat people with certain types of advanced stomach cancer and a certain type of oesophageal cancer. The oesophagus is the tube that connects the throat to the stomach. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. These types of cancer are often treated with chemotherapy or immunotherapy.

  MK-2870, the trial medicine, is a targeted therapy, which is a treatment that works on specific types of cancer cells to stop them from growing and spreading.

  The main goal of this trial is to learn if people treated with MK-2870 live longer than people treated with chemotherapy.

  About 450 people, aged 18 years and older, will be in this trial and:
  • Have a certain type of advanced cancer that:
  o Is in the stomach and/or oesophagus
  o Got worse after receiving 2 or more previous chemotherapy and/or immunotherapy treatments, and
  o Cannot be removed with surgery
  • Do not have certain types of health problems

  People will be assigned by equal chance to receive either:
  • MK-2870 through a needle into a vein as an intravenous (IV) infusion every 2 weeks
  • Chemotherapy by mouth or IV infusion (chosen by the researcher based on the type of cancer). How often people receive chemotherapy depends on the type of chemotherapy
  People will receive treatment until they cannot tolerate it, the cancer grows or spreads, or the trial ends.

  Both the people in the trial and the researcher will know which trial treatment a person is getting (open-label trial).

  People may give urine, blood, and tumour samples, have imaging tests and physical examinations, and answer questions during the trial.
  A person may be in this trial for up to 4 years.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  24/NW/0039

• Date of REC Opinion

  15 May 2024

• REC opinion

  Further Information Favourable Opinion