Brief Summary
The I-MAT trial is a randomised, placebo-controlled, phase II trial of adjuvant Avelumab in patients with stage I-III Merkel cell carcinomacancer arising from tissues that line organs aiming to explore the efficacy of avelumab as adjuvant immunotherapya treatment that uses a person's immune system to fight cancer.
Intervention / Treatment
- Drug: Avelumab
- Drug: Placebo
Inclusion Criteria
- Histologically confirmed Merkel cell carcinoma (MCC) which is either:
- clinical stage I;
- pathological stage I with positive LVSI only;
- clinical or pathological stage II (including IIA and IIB);
- clinical or pathological stage III (including IIIA and IIIB).
- Absence of distant metastatic disease on baseline 18-Fludeoxyglucose (18FDG) – Positron Emission Tomography (PET) / Computed Tomography (CT) scan.
- 18 years of age or older.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) of 0 – 2.
- Willing and able to provide written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. and comply with all study requirements.
- Adequate haematological, liver and renal function as determined by the screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening laboratory values outlined in the protocol obtained within 14 days prior to randomisation.
- Agreeable to collection of archival tumoura tissue mass that forms from groups of unhealthy cells material. Where possible, the most recently acquired tumour specimena sample for investigating (e.g. blood, stools, urine, sputum etc.) should be provided.
- Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to the start of treatment.