Melanoma

he following list provides a brief description of skin cancer trials that are open for recruitment in Western Australia. If you would like more information please follow the links provided, contact one of the trial sites or speak with your doctor.

Please note that this list is based on information provided to the Cancer Council by WA hospitals and may not include all clinical trials that are running in WA.

Where ‘N/A' appears - this means the lacking information has not been provided to date to the Cancer Council.

 

CA209-234

Registered Title Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Purpose This is an observational, multicenter study in patients treated with nivolumab for the
approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the
United States (US). Targeted countries in the EU for study participation include Austria,
Belgium, France, Germany, Italy, Spain, and the United Kingdom (UK). Study objectives are to
assess the safety experience, survival, adverse event management, and outcomes of adverse
events associated with nivolumab in routine oncology care facilities.
Lay Summary  N/A
WA Trial Sites  St John of God Subiaco Ph. (08) 6465 9204
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

LEAP-003

Registered Title A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants With Advanced Melanoma (LEAP-003)
Purpose The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advance melanoma.

The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Lay Summary  N/A
WA Trial Sites  Cancer Centre Clinical Trials Unit
Phone 08 615 26530
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine


MK3475-716

Registered Title Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)
Purpose  This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles. Participants who receive placebo or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1, do not experience disease recurrence within 6 months of completing pembrolizumab in Part 1, and do not stop treatment with pembrolizumab for disease recurrence or intolerability, may be eligible to receive up to 35 additional cycles of pembrolizumab in Part 2 in an open-label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo.
Lay Summary  N/A
WA Trial Sites  Cancer Centre Clinical Trials Unit
Phone 08 615 26530
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

PISCES

Registered Title A Multicenter Phase 2, Open Label Study of Intratumoral Tavo Plus Electroporation in Combination With Intravenous Pembrolizumab in Patients With Stage III/IV Melanoma Who Are Progressing on Either Pembrolizumab or Nivolumab Treatment
Purpose This will be a Phase 2 study of intratumoral tavokinogene telseplasmid (tavo; pIL-12) Electroporation (EP) plus IV Pembrolizumab. Eligible patients will be those with pathological diagnosis of unresectable or metastatic melanoma who are progressing or have progressed on pembrolizumab or nivolumab.
Lay Summary  N/A
WA Trial Sites  St John of God Subiaco Ph. (08) 6465 9204
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

POLARIS

Registered Title A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis
Purpose  This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis.
Lay Summary  N/A
WA Trial Sites  6 Verdun St, Nedlands WA 6009
(08) 6151 1061
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CA045-001 NKTAR

Registered Title A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma
Purpose  The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread
Lay Summary  N/A
WA Trial Sites

Linear Clinical Research 0437 873 044

Links US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

Illuminate-301

Registered Title A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with Anti-PD-1 Refractory Melanoma Ipilimumab versus Ipilimumab Alone in Subjects with Anti-PD-1 Refractory Melanoma
Purpose  A Phase 3 global, multi-center, open-label comparison of ipilimumab with and without intratumoral IMO-2125 in subjects with advanced melanoma who had confirmed disease progression while on nivolumab or pembrolizumab
Lay Summary  N/A
WA Trial Sites

FSH - Cancer Centre Clinical Trials Unit (08) 615 26530

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

Imspire 170

Registered Title

A Phase III, Open-Label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma

Purpose

This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.

Lay Summary

N/A

WA Trial Sites

Fiona Stanley Hospital Logo

Cancer Centre Clinical Trials Unit
Phone 08 615 26530 

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CA224-047

Registered Title A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Metastatic or Unresectable Melanoma 
 
Purpose
 The purpose of this study is to determine whether nivolumab in combination with relatlimab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread

 Lay Summary  N/A
 WA Trial Sites

FSH - Cancer Centre Clinical Trials Unit (08) 615 26530

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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