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Avelumab

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Antineoplastic Agents, Immunological

6 months of Avelumab at a dose of 800mg as a 60-minute intravenous (IV) infusion once every 2 weeks (13 doses)

6 months of Placebo as a 60-minute intravenous (IV) infusion once every 2 weeks (13 doses)

Placebo

Melanoma and Skin Cancer Trials Ltd Project officer

Dr Stephen Begbie

Dr Jenny Lee

Prof Georgina Long

A/Prof Alexander Guminski

Prof Michael Veness

Dr Ina Nordman

Dr Jonathon Hill

Dr Melissa Eastgate

Dr Craig Mulhall

Dr Joanne Tan

Dr Megan Lyle

Dr Hayden Christie

Dr Soe Yu Aung

Dr Zia Ansari

Dr Daniel

Dr Daniel Xing

A/Prof Victoria Atkinson

Dr Wen Xu

A/Professor Victoria Atkinson

Prof Michael Brown

Dr Christina Moldovan

Prof Mark Shackleton

A/Prof Shahneen Sandhu

Dr Gareth Rivalland

Wen Xu, MBBS, FRACP

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.

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.

Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma

A Randomised, Placebo-controlled, Phase II Trial of Adjuvant Avelumab in Patients With Stage I-III Merkel Cell Carcinoma

To identify Merkel cell polyomavirus MCPyV virus status. To correlate viral aetiology-rate of Merkel cell polyomavirus (MCPyV) positivity in pathology specimens in stage I-III Merkel cell carcinoma with outcome from adjuvant treatment.

To evaluate the relationship between somatic mutations in cancer genes or the total mutation burden of the cancer with immunotherapy response and outcome following adjuvant therapy.

To address whether immune infiltrates and PD-L1 expression are associated with survival.

To identify predictive biomarkers for response and resistance to immunotherapy in patients with stage I-III MCC using archival tissue and peripheral blood.

Recurrence-free survival (RFS) as the primary endpoint, is anticipated to be analysed over an average planned follow-up of 3.5 years. An analysis of RFS at the 24 month time point of follow-up will also be conducted as it is anticipated that the minimum follow-up for participants will be 24 months and the sample size rationale utilises RFS rates at 24 months in historical controls. RFS is defined as the time from treatment initiation until the first date of any signs or symptoms of recurrence of tumour.

Overall survival rates at 12 and 24 months. Overall survival is defined as the time from treatment initiation to the date of death due to any cause.

Disease-specific survival at 24 months from treatment initiation. Disease-specific survival is the percentage of participants who have not died from Merkel Cell Carcinoma

Rate of loco-regional failure free survival (LRFFS) is defined as the time from treatment initiation to the first recurrence of the loco-regional tumour.

DMFS is defined as the time from treatment initiation to the first evidence of distant metastatic disease.

Rate of treatment-related adverse events (AEs). Safety will be measured by serious adverse events (SAEs) and AEs assessed as per NCI CTCAE v5.0, including immune-related adverse events.

FACT-M form (version 4) will be utilised. This will include patient-reported questions relating to physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing and additional patient concerns which are measured from 0-4 (Not at all - Very Much).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma	NCT04291885	Merkel Cell Car... Merkel Cell Car... Merkel Cell Car... Merkel Cell Car... Neuroendocrine ... Carcinoma Neuro...	Avelumab Placebo	18 Years -	Melanoma and Skin Cancer Trials Limited
Immunotherapy Adjuvant Trial in Patients With Stage I-III Merkel Cell Carcinoma	NCT04291885	Merkel Cell Car... Merkel Cell Car... Merkel Cell Car... Merkel Cell Car... Neuroendocrine ... Carcinoma Neuro...	Avelumab Placebo	18 Years -	Melanoma and Skin Cancer Trials Limited

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