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RecruitingLast updated: 20 December 2023

ADELE: This phase II study is evaluating the effectiveness of 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

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 sequential adjuvant treatment of pelvic chemoradiation, followed by 4 cycles of tislelizumab and carboplatin plus paclitaxel chemotherapy, followed by tislelizumab alone for another 8 cycles.

In the Active Comparator Arm, participants will receive a sequential adjuvant treatment of pelvic chemoradiation, followed by 4 cycles of carboplatin plus paclitaxel chemotherapy. Pelvic chemoradiation should commence within 4-6 weeks after surgery, but no later than 8 weeks, and prior to chemotherapy +/- immunotherapy. Pelvic chemoradiation will be at a dose of 45Gy in 25 fractions, delivered to the clinical target volume 5 days a week for 5 weeks. Tislelizumab (200mg) will be be administered via intravenous infusion (IV) once every 3 weeks for up to 12 cycles, and carboplatin (AUC 5) and paclitaxel (175mg/m^2) will also be administered via IV once every 3 weeks.

Conditions

This trial is treating patients with high-risk endometrial cancer

Cancer

Female Reproductive System Cancers Gynaecological

Age

People18+

Phase

II

Trial Acronym

ADELE

More information

Trial Identifiers

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Trial sponsor

University of Sydney,Australia New Zealand Gynaecological Oncology Group (ANZGOG)

Scientific Title

The 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

Eligibility

Inclusion

Inclusion Criteria at REGISTRATION:

1) People aged 18 years and older, with a histological diagnosis of high-risk endometrial cancer, defined as: Note: ECs with mixed histology will be accepted.
a) FIGO 2018 stage III or IVA endometrial cancer with endometroid histology; or
b) FIGO 2018 stage II-IVA endometrial cancer with serous, clear cell or carcinosarcoma histology.
2) Completed prior surgical treatment with total hysterectomy and bilateral salpingo-oophorectomy +/- lymph node evaluation (either lymph node sampling or lymphadenectomy) and planned for adjuvant therapy
3) Have not received any prior chemotherapy for endometrial cancer
4) Have not received any prior pelvic radiation therapy
5) Adequate bone marrow function
• Haemoglobin greater or equal to 90 g/L
• Absolute neutrophil count greater or equal to 1.5 x 10^9/L
• Platelets greater or equal to 100 x 10^9/L
6) Adequate renal function
• creatinine clearance greater or equal to 50 ml/min as per Cockcroft-Gault Equation
or
• greater or equal to 50 mL/min as per measured renal nuclear glomerular filtration rate study
7) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
8) Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
9) Signed, written informed consent

Inclusion Criteria at RANDOMISATION:

10) Participants with AEs as a result of pelvic chemoradiation must have recovered to baseline or at least G1 as per CTCAE v5.0. Note patients with the following AEs that are not considered a safety risk by investigator are exempted and may proceed to randomisation: alopecia or isolated laboratory abnormalities that are not clinically significant.
11) Adequate bone marrow function
• Haemoglobin greater or equal to 90 g/L
• Absolute neutrophil count greater or equal to 1.5 x 10^9/L
• Platelets greater or equal to 100 x 10^9/L
12) Adequate liver function
• Alanine transaminase lesser or equal to .5 x upper limit of normal (ULN)
• Aspartate aminotransferase lesser or equal to 2.5 x ULN
• Total bilirubin lesser or equal to 1.5 x ULN (except participants with Gilbert’s syndrome, who are eligible with bilirubin less than or equal to 3 ULN)
13) Adequate renal function
• creatinine clearance greater or equal to 50 ml/min as per Cockcroft-Gault Equation
or
• greater or equal to 50 mL/min as per measured renal nuclear glomerular filtration rate study

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

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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