GoTHAM

Combined immunotherapy and radiotherapy to treat rare but lethal skin cancer

Merkel cell carcinoma is a rare, highly aggressive neuroendocrine skin cancer that affects around 300 Australians each year. Although Merkel cell carcinoma is rare, Australia has the highest incidence of this cancer in the world and cases are rapidly increasing.

Treatment is often successful for patients diagnosed early, but Merkel cell carcinoma has a high risk of returning with around one-third of patients experiencing recurrence.

Merkel cell carcinoma can very quickly spread to other sites of the body and is the most lethal type of skin cancer. Only around 18% of patients with metastatic Merkel cell carcinoma are expected to survive for five years.

The treatment options for Merkel cell carcinoma vary for different patients and may include a single therapy such as surgery, or a combination of therapies, such as surgery followed by radiotherapy or drug therapy.

Emerging data suggests that radiotherapy combined with immunotherapy is one of the most effective treatment options for treating metastatic Merkel cell carcinoma.  

To determine the effectiveness of this new approach, the GoTHAM Trial is investigating the use of immunotherapy drug Avelumab when combined with either conventional radiotherapy or peptide receptor radionuclide therapy.

The Australia-wide multi-centre, phase Ib / II trial aims to enrol 65 participants with metastatic Merkel cell carcinoma in all capital cities.

Eligibility

To participate in the GoTHAM trial participants must be:

  • Aged over 18
  • Have histologically confirmed metastatic Merkel cell carcinoma
  • Are treatment naïve in the metastatic setting
  • Have an ECOG Performance Status of 0-2
  • Have normal organ function

Further details about inclusion and exclusion criteria can be found here.

What's involved?

All prospective patients undergo a screening process within 28 days of their first dose Avelumab to determine eligibility for the trial.

Screening includes:

  • Medical examination, medical history and medication review
  • Laboratory tests, vital signs and ECG
  • Tumour assessments using PET, CT and MRI imaging

Once determined eligible, patients will be allocated to group based on their PET scan results and will receive either:

  • Avelumab and radiotherapy (EBRT); or
  • Avelumab and PRRT (LuTate).

The study treatment duration is up to 24 months. During this period, the patients will have trial assessments to monitor their safety and treatment progress.

Why should I join GoTHAM?

Although rare, metastatic Merkel cell carcinoma remains the most lethal form of skin cancer in Australia. Better strategies are urgently needed to improve the outcomes for patients with metastatic Merkel cell carcinoma.

The GoTHAM trial aims to develop a well-tolerated and effective immunotherapy combination to further improve disease control and overall survival for patients with metastatic Merkel cell carcinoma.

Trial resources

For healthcare providers and patients

GoTHAM Trial Team

Study Chair
A/Prof Shahneen Sandhu, Peter MacCallum Cancer Centre, VIC

Peter MacCallum Cancer Centre (VIC)
Dr Lavinia Spain (Principal Investigator)
A/Prof Grace Kong (Coordinating Nuclear Medicine Physician)
Dr Margaret Chua (Coordinating Radiation Oncologist)

Royal Brisbane and Women’s Hospital (QLD)
A/Prof David Wyld (Principal Investigator)
A/Prof David Pattison (Nuclear Medicine)
Dr Charles Lin (Radiation Oncology)
A/Prof Benjamin Chua (Radiation Oncology)

Princess Alexandra Hospital (QLD)
Dr Wen Xu (Principal Investigator)
Dr Phillip Law (Nuclear Medicine)
A/Prof Matthew Foote (Radiation Oncology)

 


Royal North Shore Hospital (NSW)
A/Prof Alex Guminski (Principal Investigator)
A/Prof Paul Roach (Nuclear Medicine)
A/Prof George Hruby (Radiation Oncology)

Sir Charles Gairdner Hospital (WA)
Dr Tarek Meniawy (Principal Investigator)
A/Prof Roslyn Francis (Nuclear Medicine)
Dr Joshua Dass (Radiation Oncology)

Royal Adelaide Hospital (SA)
Prof Michael Brown (Principal Investigator)
Dr Ian Kirkwood (Nuclear Medicine)
Dr Peter Gorayski (Radiation Oncology)

Trial sites currently recruiting patients

Victoria

Peter MacCallum Cancer Centre, Melbourne
Dr Lavinia Spain

New South Wales

Royal North Shore Hospital, Sydney
A/Prof Alex Guminski

South Australia

Royal Adelaide Hospital, Adelaide
Prof Michael Brown

Queensland

Royal Brisbane and Women’s Hospital, Brisbane
A/Prof David Wyld

Princess Alexandra Hospital, Brisbane
Dr Wen Xu

Western Australia

Sir Charles Gairdner Hospital, Perth
Dr Tarek Meniawy

Contact and more information

GoTHAM Trial news

To contact the GoTHAM clinical trial email gotham@masc.org.au

GoTHAM clinical trial Registration ID: NCT04261855

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