Immunotherapy drug trial for early-stage Merkel cell carcinoma patients
Merkel cell carcinoma is a rare, highly aggressive neuroendocrine skin cancer that affects around 300 Australians each year. Australia has the highest incidence of this cancer in the world and cases are rapidly increasing.
Even when diagnosed early, Merkel cell carcinoma has a high risk of returning, with around one-third to one-half of patients experiencing recurrence within two years.
Merkel cell carcinoma can very quickly spread to other sites of the body and is the most lethal type of skin cancer. Only around 14% of patients who develop advanced metastatic Merkel cell carcinoma are expected to survive for five years.
Treatment strategies to complement surgery and / or radiotherapy are urgently needed to prevent the cancer from metastasising and improving the survival rates for Merkel cell carcinoma patients.
The I-MAT trial, led by Melanoma and Skin Cancer Trials Ltd. (MASC Trials), is investigating the use of an immunotherapy drug after patients with early-stage Merkel cell carcinoma have had initial surgery and / or radiotherapy treatment for the cancer.
I-MAT will determine if a six-month treatment regime of Avelumab is well-tolerated and can eliminate residual microscopic cancer cells, thus reducing the risk of the cancer reoccurring and improving the overall outcomes for patients with early-stage Merkel cell carcinoma.
The trial aims to enrol 132 participants with stage I-III Merkel cell carcinoma throughout Australia, including capital cities and many regional towns.
Participants in the phase II, prospective, randomised, placebo-controlled, multi-institutional trial will receive either Avelumab or a placebo for six months, and have follow-up assessments for five years.
Participants in the I-MAT trial must be 18 years or older, present with an ECOG of 0-2 and have been diagnosed with stage I-III Markel cell carcinoma.
Further details about inclusion and exclusion criteria can be found here.
Once determined eligible, participants will be randomised into a group that receives either a six-month treatment of Avelumab or a placebo.
Participation in the I-MAT trial runs for five years. During this time, follow-up assessments will occur for:
- Year 1 – every three months
- Year 2 – every four months
- Years 3 to 5 – every six months.
Why should I join I-MAT?
Better treatment strategies are urgently needed to improve the outcomes for patients with Merkel cell carcinoma.
Immunotherapy drugs have really made a big difference in vastly improving the treatment of advanced Merkel cell carcinoma, but as yet there is no evidence to support their use as an adjuvant treatment for early-stage Merkel cell carcinoma.
The I-MAT trial aims to demonstrate that for early-stage Merkel cell carcinoma patients, Avelumab when used after surgery and / or radiotherapy can increase cure rates, is well-tolerated, and improves the quality for life for patients with this cancer.
The outcomes of the I-MAT trial may influence future treatment strategies world-wide for patients with this rare, but often lethal cancer.
For healthcare providers and patients
I-MAT Trial Team
- Dr Wen Xu (Study Chair)
- Dr Stephen Begbie
- Prof Michael Veness
- Prof Georgina Long
- Dr Ina Nordman
- A/Prof Alexander Guminski
- Dr Jenny Lee
- Dr Melissa Eastgate
- Dr Craig Mulhall
- Dr Joanne Tan
- Dr Megan Lyle
- Dr Madhavi Chilkuri
- Dr Hayden Christie
- Dr Soe Yu Aung
- Dr Zia Ansari
- A/Prof Victoria Atkinson
- Prof Michael Brown
- Dr Christina Moldovan
- A/Prof Shahneen Sandhu
- Prof Mark Shackleton
Trial sites currently recruiting patients
New South Wales
Westmead Hospital, Sydney
Email Michael.Veness@health.nsw.gov.au | Phone +61 2 8890 5200
Melanoma Institute Australia, Sydney
Email Georgina.Long@sydney.edu.au | Phone: +61 2 9911 7336
Calvary Mater Hospital, Sydney
Email Ina.Nordman@calvarymater.org.au | Phone +61 2 4014 3190
Royal North Shore Hospital, Sydney
Email Alexander.Guminski@health.nsw.gov.au | Phone +61 2 9926 5020
Chris O’Brien Lifehouse, Sydney
Email Jenny.Lee@lh.org.au | Phone +61 2 9383 1014
Port Macquarie Base Hospital, Port Macquarie
Royal Brisbane and Women’s Hospital, Brisbane
Email Melissa.Eastgate@health.qld.gov.au | Phone +61 7 3646 9917
Princess Alexandra Hospital, Woolloongabba (Brisbane)
Email firstname.lastname@example.org | Phone +61 7 3176 2111
Cancer Care Service, Bundaberg Base Hospital, Bundaberg
Email WBHHS-Cancer-Care-Research@health.qld.gov.au | Phone +61 7 4154 9900
Cancer Care Service, Hervey Bay Hospital, Hervey Bay
Email WBHHS-Cancer-Care-Research@health.qld.gov.au | Phone +61 7 4325 6110
Mackay Hospital and Health Service, Mackay
Email Zia.Ansari@health.qld.gov.au | Phone +61 7 4885 7952
Townsville Hospital, Townsville
Email Madhavi.Chilkuri@health.qld.gov.au |Phone +61 7 4433 1801
Contact and more information
17 November 2020
I-MAT clinical trial – improving MCC management
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