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Phase 3 study of pembrolizumab vs chemotherapy in dMMR advanced or recurrent endometrial carcinoma

  • Research type

    Research Study

  • Full title

    A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)

  • IRAS ID

    1005024

  • Contact name

    - -

  • Contact email

    N/A

  • Sponsor organisation

    Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

  • Eudract number

    2021-003185-12

  • Clinicaltrials.gov Identifier

    NCT05173987

  • Research summary

    Endometrial Carcinoma (EC) is a disease in which malignant (cancer) cells form in the tissue of the endometrium. The endometrium is the lining of the uterus, a hollow, muscular organ in a woman's pelvis. Chemotherapy has been the standard of care (SoC) treatment for women with advanced or recurrent EC. This trial is testing pembrolizumab against chemotherapy in people with Mismatch Repair Deficient (dMMR) advanced or recurrent EC, who have not previously been treated with SoC chemotherapy. About 350 female participants, aged 18 years or older will take part in this trial.
    Pembrolizumab (also called KEYTRUDA®) has been approved to treat many other types of cancers. This trial is comparing the overall survival and progression free survival of pembrolizumab vs chemotherapy. The chemotherapies being used in this trial are standard treatments for people with this type of cancer.
    There is a screening phase to see if patients can join the trial lasting about one month.
    Participants then join 1 of the following 2 treatment arms with a 50/50 chance of being in either group.
    - Arm 1: Pembrolizumab every 6 weeks for 18 cycles with a possibility of an extra 9 cycles if your cancer worsens after the first 18 cycles of treatment ended.
    - Arm 2: Combination of paclitaxel every 3 weeks (Q3W) and carboplatin every Q3W for 6 cycles Docetaxel Q3W or weekly and Cisplatin Q3W may also be considered for participants in the chemotherapy arm.
    As this is a Crossover study if you are in the chemotherapy arm 2 and your cancer worsens you may be able to go on to receive the same amount of pembrolizumab treatment as received in arm 1.
    The Sponsor estimates that the trial will require approximately 50 months from the time the first participant agrees to take part until the last trial related contact.
    The trial is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (MSD).

  • REC name

    North West - Greater Manchester Central Research Ethics Committee

  • REC reference

    22/NW/0076

  • Date of REC Opinion

    22 Apr 2022

  • REC opinion

    Further Information Favourable Opinion