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Proposed Trials

ANZMTG Trials in Development

-- Proposed Trial -- ANZMTG 01.17 STOP GAP Trial - Canadian Collaborative Group Protocol: STOP-GAP - A randomised phase III study of duration of anti-PD1 therapy in metastatic melanoma; this proposal is for a parallel sister protocol running in ANZ

The advent of breakthroughs in immunotherapy is changing the historically poor survival rates of patients with advanced melanoma. Both PD 1 inhibitors nivolumab and pembrolizumab have demonstrated significant efficacy against metastatic melanoma. As physicians do not know what the “best” anti-PD-1 treatment duration for melanoma patients is, genuine uncertainty (“clinical equipoise”) exists. 

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-- Proposed Trial -- ANZMTG 03.17 Can patient-led surveillance detect more early stage recurrent or new primary melanoma than clinician-led surveillance?

An increasing number of patients in Australia require lifelong follow-up after treatment for localised melanoma, and dermatology and skin cancer clinics are struggling with this demand. An alternative model of  to the traditional 'clinician-led' surveillance is 'patient-led' surveillance: combination of smartphone supported self-examination, teledermatology and patient initiated clinic visits when needed.

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-- Proposed Trial -- ANZMTG 04.17

Improving skin cancer prevention: motivating preventive behaviours using knowledge of personalised genomic risk of melanoma

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-- Proposed Trial -- ANZMTG 03.14 PRISM Prospective multisite evaluation of the roles of18F-FDG PET and Sentinel lymph node mapping and biopsy in the diagnostic workup of Merkel Cell carcinoma

Merkel cell carcinoma (MCC) is an uncommon, highly aggressive neuroendocrine skin malignancy with a generally poor prognosis and propensity to recur loco-regionally and at distant sites. Its optimal work-up and treatment are uncertain and there is generally a lack of prospective trials.

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-- ON HOLD - ANZMTG 04.12 REFORM - Radiotherapy followed by selective nodal dissection for high volume regional melanoma: A phase II trial

Currently there is no standard treatment approach for patients with high volume nodal melanoma. Most patients receive up front surgery and generally receive adjuvant radiotherapy. Irrespective of the approach both radiotherapy and surgery are commonly used but the order of these two modalities is at the treating clinicians’ discretion. This is a phase II trial of radiotherapy followed by selective nodal dissection in patients presenting with high volume regional nodal melanoma. The primary objective of this study is to investigate the1-year major complication free nodal control rate

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-- ON HOLD -- ANZMTG 02.13 A randomised phase II study of immunotherapy with DPCP treated autologous melanoma vaccines

Previous studies have suggested that immunotherapy with chemically coated (haptenized) autologous melanoma cells may be associated with regression of metastases and increased relapse free survival (RFS) in patients with AJCC stage IV and inoperable stage III melanoma. This study aims to further explore the possible efficacy of this approach in patients with melanoma with minimal disease following surgery or treatment with selective BRAF inhibitors.

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-- ON HOLD -- ANZMTG 03.13 A randomized controlled trial in T1N0 Merkel Cell Carcinoma of either radiotherapy to the primary site or wide local excision following diagnostic biopsy

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