ADELE: Pelvic chemoradiation therapy, followed by chemotherapy (carboplatin and paclitaxel), with or without immunotherapy (tislelizumab), in people with endometrial cancer who have had surgeryThe effect of adjuvant tislelizumab plus chemotherapy on failure free survival after post-operative pelvic chemoradiation in high risk endometrial cancer - ADELE: a randomised phase 2 trial

Exclusion

1) Uterine sarcoma [apart from carcinosarcoma]
2) Active autoimmune disease or history of autoimmune disease that may deteriorate or relapse when receiving an immunostimulatory agent.
[Note: participants with the following conditions are not excluded and may proceed to further screening:
a) Autoimmune skin disease not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)
b) controlled type 1 diabetes mellitus
c) hypothyroidism (managed with hormone replacement therapy only)]
3) Any contraindications to receiving platinum and paclitaxel chemotherapy or pelvic radiation
4) Serious medical or psychiatric conditions that may prevent compliance with the protocol or compromise assessment of key outcomes of the study
5) Participants with other active invasive malignancies, except for non-melanoma skin cancer, or in situ melanoma, or a solid tumour treated with curative intent and no evidence of disease recurrence for more than 3 years.
6) Any condition that required systemic treatment with either corticosteroids (>10mg daily of prednisone or equivalent) or other immunosuppressive medication lesser or equal to 14 days before randomisation
[Note: participants who are currently or have previously been on any of the following steroid regimens are not excluded:
a) Adrenal replacement steroid (dose lesser or equal to 10 mg daily of prednisone or equivalent)
b) Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
c) Short course (lesser or equal to 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen) or as supportive medication for before and after chemotherapy]
7) Active hepatitis B or hepatitis C virus infection
8) A known history of HIV infection
9) Known history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
10) Significant acute or chronic infections including but not limited to:
a) Participants with active tuberculosis (history of exposure or history of positive tuberculosis test; plus presence of clinical symptoms, physical, or radiographic findings).
a) Active bacterial or fungal infection requiring systemic therapy
11) Prior allogeneic stem cell transplantation or organ transplantation
12) Any of the following cardiovascular conditions:
a) Unstable angina
b) Any history of acute myocardial infarction lesser or equal to 6 months before randomisation
c) Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV lesser or equal to 6 months before randomisation
d) Any event of ventricular arrhythmia greater than or equal to Grade 2 in severity lesser than or equal to 6 months before randomisation
e) Any history of cerebrovascular accident lesser or equal to 6 months before randomisation
13) Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
14) Receipt of live attenuated vaccination within 30 days prior to enrolment or within 30 days of receiving tislelizumab