MK-2870 in Second-line Recurrent or Metastatic Cervical Cancer
Research type
Research Study
Full title
A Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice as Second-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20)
IRAS ID
1009852
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Research summary
Researchers are looking for new ways to treat recurrent or metastatic cervical cancer. Recurrent means the cancer came back after treatment. Metastatic means the cancer has spread to other parts of the body.
Researchers want to know if MK-2870, the trial medicine, can treat recurrent or metastatic cervical cancer. MK-2870 is an antibody drug conjugate (ADC), which attaches to specific targets on cancer cells and delivers treatment to destroy those cells.
About 686 women aged 18 years and older with cervical cancer will be in this trial and:
• Had cervical cancer come back after previous treatment with chemotherapy and immunotherapy
• Do not have weakness, numbness, or pain in their hands and feet (called peripheral neuropathy)People will receive either:
• MK-2870 given once every 2 weeks,
• Researcher’s choice of treatment given one or more times every 3 or 6 weeks. The researcher will choose:
o An ADC similar to MK-2870 (for the UK, this treatment will not be in the trial)
o 1 of 5 types of chemotherapyPeople will receive the treatments through a needle into a vein as an intravenous (IV) infusion. People will receive treatment until the cancer gets worse or the person does not tolerate treatment.
The trial will have 2 parts:
Part 1: Researchers will test only MK-2870 for safety and to measure how cancer responds in a small group of people. They will check for safety concerns before giving MK-2870 in Part 2.
Part 2: Researchers will test MK-2870 and the other treatments to learn how cancer responds to the treatments in a larger group of people.People will give urine and blood samples, have tests to check their heart, have tumour and imaging tests, have physical examinations and will answer sets of questions. A person may be in this trial for about 4 years.
REC name
London - London Bridge Research Ethics Committee
REC reference
24/LO/0502
Date of REC Opinion
6 Aug 2024
REC opinion
Further Information Favourable Opinion