Trial purpose
Cancer treatment
Tumor type
Gynaecological
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm.
In the Experimental Arm, participants will receive pembrolizumab (400mg) via intravenous infusion (IV) on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years).
In the Active Comparator Arm, participants will receive a combination of paclitaxel (175mg/m^2) on Day 1 of each 3-week cycle and carboplatin (AUC 5 or 6) on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). Participants who experience a severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel (75mg/m^2) in place of paclitaxel on Day 1 Q3W after Sponsor consultation. Participants who experience a severe hypersensitivity reaction to carboplatin or an AE requiring discontinuation of carboplatin may receive cisplatin (75mg/m^2) in place of carboplatin on Day 1 Q3W after Sponsor consultation.
Conditions
This trial is treating people with endometrial cancer
Eligibility
Inclusion
The main inclusion and exclusion criteria include but are not limited to the following:
Exclusion
- Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed.
- Has EC of any histology that is proficient mismatch repair (pMMR).
- Is a candidate for curative-intent surgery or curative-intent radiotherapy.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]).
- Has received prior systemic anticancer therapy including investigational agents for any advanced or metastatic EC. (Note: Prior chemotherapy administered as adjuvant therapy, neoadjuvant therapy, and/or concurrently with radiation is permitted.
- Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has a known intolerance to any study intervention and/or any of its excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection, requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has had an allogenic tissue/solid organ transplant.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Merck, European Network of Gynaecological Oncological Trial Groups (ENGOT)
Scientific 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)
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