A study with chemotherapy plus pembrolizumab or placebo after curative surgery for endometrial cancer in women 18 years or older
- Conditions
- MedDRA version: 21.0Level: PTClassification code 10014733Term: Endometrial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-003424-17-NO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 990
Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:
a) Has undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy. Pelvic lymph node sampling, paraaortic lymph node sampling, including sentinel lymph node, and lymph node dissection are optional but strongly encouraged.
b) Is at high risk for recurrence following treatment with curative intent surgery, ie, one of the following:
- FIGO (2009) Surgical Stage I/II with myometrial invasion of nonendometrioid histology including serous adenocarcinoma, clear cell carcinoma, mixed epithelial carcinoma, dedifferentiated/undifferentiated carcinoma or carcinosarcoma.
- FIGO (2009) Surgical Stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation
- FIGO (2009) Surgical Stage III or IVA of any histology
2. Is disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.
3. Has not received any radiation or systemic therapy, including immunotherapy or hormonal therapy or HIPEC, in any setting including the neoadjuvant setting for EC.
4. Is female and at least 18 years of age at the time of providing documented informed consent.
5. Has ECOG performance status of 0 or 1 within 7 days before randomization.
6. The participant (or legally acceptable representative) has provided documented informed consent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
7. Submission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and MMR status by central vendor is required for all participants.
8. Have adequate organ function. Specimens must be collected within 7 days before randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 495
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 495
1. Has recurrent endometrial carcinoma or carcinosarcoma.
2. Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed.
3. Has FIGO (2009) Surgical Stage I/II EC of endometrioid histology without a known aberrant p53 expression or p53 mutation.
4. Is known to have a POLE mutation.
5. Has FIGO Stage IVB disease of any histology even if there is no evidence of disease after surgery.
6. Has residual tumor whether measurable or nonmeasurable after surgery.
7. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
8. 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 (eg, CTLA-4, OX-40, CD137).
9. Has received a live vaccine within 30 days before the first dose of study intervention.
10. Has a known intolerance to study intervention (or any of the excipients).
11. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
12. Has any contraindication to the use of carboplatin or paclitaxel.
13. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
14. Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
15. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement
therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
16. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
17. Has an active infection requiring systemic therapy.
18. Has a known history of HIV infection.
19. Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
20. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
21. Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study.
22. Has had an allogenic tissue/solid organ transplant.
23. Has not recovered adequately from surgery and/or any complications from the surgery.
24. Is breastfeeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method