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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
122
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
Cancer Care Wollongong
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
...and 10 more locations
Recurrence-free survival (RFS)
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.
Time frame: 24 Months
Overall survival (OS)
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.
Time frame: 24 Months
Disease-specific survival (DSS)
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
Time frame: 24 Months
Rate of loco-regional failure free survival (LRFFS)
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.
Time frame: 24 Months
Distant metastasis-free survival (DMFS)
DMFS is defined as the time from treatment initiation to the first evidence of distant metastatic disease.
Time frame: 24 Months
Treatment toxicity and tolerability as assessed by NCI CTCAE v5.0
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.
Time frame: 24 Months
Patient-reported quality of life (QoL) as assessed by FACT-M questionnaire
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).
Time frame: 24 Months
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