I-MAT

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.

Eligibility

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.

What's involved?

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.

Trial resources

For healthcare providers and patients

  • Video about the I-MAT trial featuring Dr Wen Xu (Study Chair), Prof Gerald Fogarty (Chair of AMIGOs) and Jonathan Pincus (Merkel cell carcinoma patient)
  • Australasian Merkel Cell Carcinoma Interest Group (AMIGOs) website

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

Queensland

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
Email Stephen.Begbie@health.nsw.gov.au

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 victoria.atkinson@health.qld.gov.au | 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    

Cairns Hospital, Cairns
Email Megan.Lyle@health.qld.gov.au | Phone +61 7 4226 7383    
Email Madhavi.Chilkuri@health.qld.gov.au | Phone +61 7 4433 1801    

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   

Victoria

Tasmania

Peter MacCallum Cancer Centre, Melbourne
Email Shahneen.Sandhu@petermac.org | Phone +61 03 8559 5000

Alfred Hospital, Prahran (Melbourne)
Email mark.shackleton@monash.edu | Phone +61 3 9076 3129

Icon Cancer Centre, Hobart
Email hobart.research@icon.team | Phone +61 3 6240 2600    

South Australia

Royal Adelaide Hospital, Adelaide
Email MichaelP.Brown@sa.gov.au | Phone + 61 8 8302 7827    

Contact and more information

I-MAT News

To contact the I-MAT clinical trial email imat@masc.org.au

I-MAT clinical trial Registration ID: NCT04291885

For information on how to participate in a clinical trial, click here