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Brief Title: Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma
Official Title: A Randomised, Placebo-controlled, Phase II Trial of Adjuvant Avelumab in Patients With Stage I-III Merkel Cell Carcinoma
Study ID: NCT04291885
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 carcinoma aiming to explore the efficacy of avelumab as adjuvant immunotherapy.
Detailed Description: The I-MAT trial is a phase II, prospective, randomised, placebo-controlled, multi-institutional trial for patients with stage I-III Merkel cell carcinoma (MCC). Participants on the trial will receive either avelumab or placebo for 6 months. The primary aim of the I-MAT trial is to develop an effective, well-tolerated adjuvant immunotherapy regimen for patients with stage I-III MCC, post a range of definitive loco-regional treatment options.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia
Chris O'Brien Lifehouse, Sydney, New South Wales, Australia
Melanoma Institute Australia, Sydney, New South Wales, Australia
Royal North Shore Hospital, Sydney, New South Wales, Australia
Westmead Hospital, Sydney, New South Wales, Australia
Calvary Mater Hospital, Sydney, New South Wales, Australia
Southern Medical Day Care Centre, Wollongong, New South Wales, Australia
Royal Brisbane and Woman's Hospital, Brisbane, Queensland, Australia
Cancer Care Service, Bundaberg Base Hospital, Bundaberg, Queensland, Australia
Cairns Hospital, Cairns, Queensland, Australia
Cancer Care Service, Hervey Bay Hospital, Hervey Bay, Queensland, Australia
Mackay Hospital and Health Service, Mackay, Queensland, Australia
Townsville Hospital, Townsville, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Icon Cancer Centre Hobart, Hobart, Tasmania, Australia
Alfred Hospital, Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Auckland City Hospital, Auckland, , New Zealand
Name: Wen Xu, MBBS, FRACP
Affiliation: Princess Alexandra Hospital
Role: STUDY_CHAIR