Active Trials Closed for Recruitment

Melanoma and Skin Cancer Trials brings together health professionals to coordinate clinical trials across our numerous melanoma and skin cancer trial sites located at hospitals and clinics throughout Australia and overseas.

The clinical trials listed below are closed to recruitment and are no longer enrolling patients. However, each trial is still active and participants continue to receive an intervention or are being examined. Click on the links below for further information about our active trials that are closed for recruitment.

Melanoma and Skin Cancer Trials cannot enrol patients into a trial. Learn how to participate in one of our clinical trials here.

Metastatic Melanoma

Melanoma

Neurotropic Melanoma

Lentigo Maligna

Merkel Cell Marcinoma

02.12 RADICAL

03.18 I-MAT

01.12 EAGLE FM

Evaluation of groin lymphadenectomy extent for metastatic melanoma - A randomised phase III trial to evaluate survival, morbidity, and quality of life

Chair

Professor Andrew Spillane

Registration ID

ACTRN12614000721606

Trial Status

Active Trial Closed for Recruitment

Trial Summary

In its advanced stages, melanoma can spread to lymph nodes of the body, such as the inguinal lymph nodes of the groin. To remove the affected inguinal nodes, an inguinal lymphadenectomy (IL) is usually performed. An alternative approach is an Ilio-inguinal lymphadenectomy (I-IL). This is a more surgically extensive option, in which extra lymph nodes are removed.

There is current debate over which of these two surgical interventions are more effective. The EAGLE FM study is investigating which intervention is optimal for patients in terms of quality of life, survival and side effects of the surgery.

This is a phase III randomised-control study, with 101 participants across Australia monitored over a period of 10 years.

MASC Trials Contact

eaglefm@masc.org.au

01.15 CHARLI

A Phase Ib/II Trial of Ipilimumab-Nivolumab-Denosumab and Nivolumab-Denosumab in Patients with Unresectable Stage III and IV Melanoma

Chair

Associate Professor Shahneen Sandhu

Registration ID

ACTRN12617000772347

Trial Status

Active Trial Closed for Recruitment

Trial Summary

Stage III and IV melanoma is associated with a poor prognosis and cannot to be treated with surgical removal alone. One of the remaining treatment options includes immunotherapy, which helps the body’s immune system to fight the cancer.

In Australia, there are currently two approved agents for advanced melanoma – Nivolumab and Ipilimumab. However, recent evidence suggests that adding Denosumab may boost the efficacy of these agents.

The CHARLI trial is investigating whether adding Denosumab to combination immunotherapy is more effective for survival compared to the combination immunotherapy alone in patients with unresectable stage III and IV melanoma. This is a phase Ib/II trial involving 52 participants.

MASC Trials Contact

charli@masc.org.au

02.12 RADICAL

A randomised controlled multicentre trial of imiquimod versus radiotherapy for lentigo maligna when staged surgical excision with 5mm margins is not possible, is refused, or fails

Chair

Associate Professor Pascale Guitera

Registration ID

ACTRN12615000266561

Trial Status

Active Trial Closed for Recruitment

Trial Summary

Lentigo maligna is an early form of melanoma that is confined to the upper layer of the skin. The preferred treatment option is surgical excision of the lesion. However, this may not be possible for all patients or may fail, thus other treatment options need to be explored.

The RADICAL trial is examining how a topical cream, Imiquimod, compares to radiotherapy in successfully treating lentigo maligna when surgical excision is not possible.

This is a multi-centre randomised controlled trial, involving 126 participants across Australia who will be monitored for 24 months.

MASC Trials Contact

radical@masc.org.au

02.19 IMAGE

Melanoma Surveillance Photography to improve early detection of melanoma in very high risk (or high risk) patients

Chair

Associate Professor Victoria Mar

Registration ID

NCT04385732

Trial Status

Active Trial Closed for Recruitment

Trial Summary

Melanoma surveillance photography is a comprehensive surveillance method. To date, there is insufficient evidence that Melanoma Surveillance Photography improves outcomes. Currently, melanoma surveillance photography is not used routinely during skin examinations as part of ‘standard care’. Melanoma Surveillance Photography is not reimbursed by Medicare and is often costly.

This project will test whether people who are monitored with Melanoma Surveillance Photography, have fewer benign lesions removed or sampled, compared to those who do not have Melanoma Surveillance Photography.

The IMAGE clinical trial will help provide the information needed by the Medical Services Advisory Committee (the committee advising the Australian Government on the public funding of new medical services), to decide if Melanoma Surveillance Photography should be covered by Medicare.

MASC Trials Contact

image@masc.org.au

03.12 MelMarT Pilot

A Phase III, multi-centre, multi-national randomised control trial investigating 1cm vs 2cm excision margins for primary cutaneous melanoma

Chair

Professor Michael Henderson and Professor Marc Moncrieff

Registration ID

ACTRN12614000667617

Trial Status

Active Trial Closed for Recruitment

Trial Summary

Current treatment for skin melanoma includes surgical removal of the lesion. This study is investigating whether reducing the amount of skin removed in surgery is just as effective in preventing return of the cancer, whilst improving the patient’s quality of life. In this trial, a surgical margin of 1cm compared to 2cm is being tested.

This is a multi-national, multi-centre randomised controlled trial, with 400 participants from Australia, UK, Canada and Sweden. These participants are monitored over a period of 5 to 10 years.

MASC Trials Contact

melmart@masc.org.au

03.18 I-MAT

A randomised, placebo-controlled, Phase II trial of adjuvant Avelumab in patients with stage I-III Merkel cell carcinoma

Chair

Associate Professor Wen Xu

Registration ID

NCT04291885

Trial Status

Active Trial Closed for Recruitment

Trial Summary

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.

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 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.

This is a phase II multi-centre randomised placebo-controlled study, involving 120 participants across Australia and New Zealand monitored over a period of 5 years.

MASC Trials Contact

imat@masc.org.au

01.09 RTN2

A randomised trial of post-operative radiation therapy following wide excision of neurotropic melanoma of the head and neck

Chair

Associate Professor Matthew Foote

Registration ID

ACTRN12610000478011

Trial Status

Active Trial Closed for Recruitment

Trial Summary

Neurotropic melanoma is a rare form of malignant cutaneous melanoma invading the nerves. Although distant spread of neurotropic melanoma is rare, there is a higher tendency for local return of this cancer compared to conventional melanoma.

Treatment usually involves wide local excision of the lesion, palliative radiotherapy or chemotherapy in advanced cases.

The RTN2 study aims to compare whether surgery alone or surgery plus post-operative radiation therapy for neurotropic melanoma is more effective for reducing the time to local recurrence of the cancer.

This is a phase III Australia-wide randomised control trial, involving 50 participants with neurotropic melanoma who will be monitored over 5 years.

MASC Trials Contact

rtn2@masc.org.au