Research

AMIGOs facilitate enrolment in and support the completion of high quality clinical trials to enable access to better care for patients with Merkel Cell Carcinoma.

What is a clinical trial?

 

Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new intervention (eg. drugs/treatments) and what side effects might occur. This helps to determine if a new intervention works, if it is safe, and if it is better than the interventions that are already available.

AMIGOs mission is to facilitate the enrolment in clinical trials and support the completion of high quality trials, as the information provided from these trials will inform the Pharmaceutical Benefits Advisory Committee about the most appropriate treatments to provide for patients with MCC and will influence the cost of drug therapy in future.

  • Types of clinical trials
  • Phases of clinical trials
  • Who can take part in a clinical trial
  • Advantages and disadvantages
  • What clinical trial results mean and how they are used

Why participate in a clinical trial?

Australian clinical researchers conduct internationally recognised high-quality clinical trials. They have a wealth of knowledge and expertise that is helping to improve health care both in Australia and around the world. Clinical research also improves our health care service by improving patient care practices.

Participating in clinical trials may contribute to better understanding of, or better treatment or a potential cure for their disease or condition. In some cases, clinical trials can provide access to new interventions (eg. drugs/treatments) before they are widely available.

Trials also offer the hope of developing better interventions or tests for a particular disease or condition, so that even if a trial does not provide a benefit for an individual, it may provide benefits for others with the disease in the future.

As a patient participant, even when you receive the highest quality care, you may also benefit from additional support and attention provided by clinical trial staff who understand your disease or condition.

How do I find a clinical trial?

 

Clinical trials can be difficult to find as a patient, you may also have difficulty understanding whether or not the trial is suitable for your situation. The following resources may help you identify available clinical trials. If you have any questions about your eligibility for a trial, make sure to take note of the name or registration ID of the trial so that you can consult with your medical professional regarding your potential eligibility.

You may visit the Melanoma and Skin Cancer Trials (MASC) Limited app to find a trial that may be suitable for you. The registry will provide you with details about where the trials are available and who is the best contact person.

Upcoming Merkel Cell Carcinoma Trials

 

 

Clinical Trial Title:

A randomised, double-blind, placebo-controlled, multi-institutional phase II study of adjuvant anti-PD-1 in patients with stage I-III Merkel cell carcinoma [03.18 I-MAT Study]

Lead Clinician:

Dr Wen Xu (Princess Alexandra Hospital, QLD)

Summary:

Merkel cell carcinoma (MCC) is a rare but highly aggressive type of skin cancer with a higher incidence in Australia than anywhere else in the world. MCC mainly affects the elderly and those with weak immune systems and extensive sun exposure. The majority of patients present with early stage MCC, which is usually treated with surgery +/- radiotherapy. This study would like to investigate whether the use of immunotherapy, which has proven to be effective in advanced MCC, can prevent the cancer coming back following surgery, when given together with radiotherapy. Current participating sites include:
Princess Alexandra Hospital (QLD)
Townsville Hospital (QLD)
Royal Brisbane and Women’s Hospital (QLD)
Melanoma Institute Australia (NSW)
Chris O’Brien Lifehouse (NSW)
Westmead Hospital (NSW)
Calvary Mater Hospital (NSW)
Royal North Shore Hospital (NSW)
Peter MacCallum Cancer Centre (VIC)
Alfred Hospital (VIC)
Royal Adelaide Hospital (SA)
Affinity Oncology (WA)

The I-MAT trial has been registered on clinicaltrials.gov and the trial registration number is NCT04291885. The project can be viewed here – https://clinicaltrials.gov/ct2/show/NCT04291885.

 

 

Clinical Trial Title:

Combination of Avelumab with Peptide Receptor Radionuclide Therapy or Conventional Fractionated Radiotherapy in Metastatic Merkel Cell Carcinoma [10.17 GoTHAM study]

Lead Clinician:

A/Prof Shahneen Sandhu (Peter MacCallum Cancer Centre, VIC)

Summary:

Merkel cell carcinoma is a rare and highly lethal skin cancer, mostly affecting the elderly and those with weak immune systems. Only 18% of patients with metastatic Merkel cell carcinoma (mMCC) are currently expected to survive for 5 years. Although new immunotherapy is very promising, many patients still don’t respond. Radiation can make these immunotherapy drugs work better. Therefore, two types of radiation will be combined with the immunotherapy in this trial to improve responses for patients with mMCC. Current participating sites include: 
Peter MacCallum Cancer Centre (VIC)
Princess Alexandra Hospital (QLD)
Royal Brisbane and Women’s Hospital (QLD)
Royal North Shore Hospital (NSW)
Royal Adelaide Hospital (SA)
Sir Charles Gairdner Hospital (WA)

The GoTHAM trial has been registered on clinicaltrials.gov and the trial registration number is NCT04261855. The project can be viewed here https://clinicaltrials.gov/ct2/show/NCT04261855.