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.

 

CLXH254C12201

Registered Title   A Randomized, Open-label, Multi-arm, Two-part, Phase II Study to Assess Efficacy and Safety of Multiple LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic BRAFV600 or NRAS Mutant Melanoma
 Purpose  The primary purpose of this study is to evaluate the efficacy of LXH254 combinations in
previously treated unresectable or metastatic melanoma
 Lay Summary  N/A
 WA Trial Sites    Oncology  Ph. (08) 6465 9204
 Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

GO42273

Registered Title   A Phase Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Atezolizumab in Patients With NRAS-Mutant Advanced Melanoma Who Have Received Anti-PD-1/PD-L1 Therapy
 Purpose  This study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a
single agent and in combination with either cobimetinib or cobimetinib plus atezolizumab in
patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.
 Lay Summary  N/A
 WA Trial Sites   Ph. 08 6382 5513
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

HBI-8000-313

Registered Title   A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined With Nivolumab Versus Placebo With Nivolumab in Patients With Unresectable or Metastatic Melanoma Not Previously Treated With PD-1 or PD-L1 Inhibitors
 Purpose  This is a phase 3 study to compare the efficacy and safety of HBI-8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma and eligible patients who are not adolescents or patients with new, progressive brain metastasis will be stratified by
PD-L1 expression and LDH level.
 Lay Summary  N/A
 WA Trial Sites   Ph. (08) 9242 7640
 Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

EVX-02-001

Registered Title A Phase 1/2, Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1 After Complete Resection of Stage IIIB/IIIC/IIID or Stage IV Melanoma in Patients at High Risk for Recurrence
Purpose  This is a Phase 1/2, open label, multi-centre study to assess the safety, tolerability, PD,
and efficacy of adjuvant immunotherapy EVX-02 vaccine and anti-PD-1 (Nivolumab) in patients
who have had a complete resection of a Stage IIIB/IIIC/IIID or Stage IV melanoma who are at
high risk of recurrence.
Lay Summary  N/A
WA Trial Sites  ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

EMBRACE

Registered Title Phase II clinical trial of the PARP inhibitor, olaparib, in HR-deficient metastatic breast and relapsed ovarian cancer in patients without germline mutations in BRCA1 and BRCA2: The EMBRACE study 
Purpose This study is testing olaparib, in Homologous recombination (HR) deficient metastatic breast and relapsed ovarian cancer in patients who do not have hereditary mutations in BReast CAncer susceptibility gene 1 and gene 2 (BRCA1 and BRCA2).
Lay Summary  N/A
WA Trial Sites   Oncology Ph. 08 615 26530
Links  Australian New Zealand Clinical Trial Registry

Acknowledgments: Australian New Zealand Clinical Trial Registry

 

PIVOT-12

Registered Title  A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)
Purpose  The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.
Lay Summary  N/A
WA Trial Sites  (08) 9242 7640
Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

MK3475-U02B-00

Registered Title  A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma: Substudy 02B
Purpose Substudy 02B is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy.

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

 

MK-3475-02C

Registered Title A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma: Substudy 02C
Purpose Substudy 02C is part of a larger research study that is testing experimental treatments for
melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02C is to evaluate the safety and efficacy of investigational treatment
arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to
identify the investigational agent(s) that, when used in combination, are superior to the
current treatment options/historical control available.

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

Acknowledgements: US National Library of Medicine

 

MK-3475-02A

Registered Title  A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma: Substudy 02A
Purpose Substudy 02A is part of a larger research study that is testing experimental treatments for
melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment
arms in participants with PD-1 refractory melanoma to identify the investigational agent(s)
that, when used in combination, are superior to the current treatment options/historical
control available.

Lay Summary  N/A
WA Trial SItes  Cancer Centre Clinical Trials Unit Ph. 08 615 26530
Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

V937-011

Registered Title A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma
Purpose  This is a Phase 2 study to assess the efficacy, safety, and tolerability of V937 administered
both intratumorally (IT) and intravenously (IV) as combination therapy with pembrolizumab
(MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1
(anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma.
Lay Summary  N/A
WA Trial Site  Cancer Centre Clinical Trials Unit Ph. 08 615 26530
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

KEYNOTE-942

Registered Title A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma (KEYNOTE- 942)
Purpose  The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157
and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in
patients with complete resection of cutaneous melanoma and a high risk of recurrence.
Lay Summary  N/A
WA Trial Sites  Ph. (08) 6465 9204
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CheckMate-76K / CA209-76K

Registered Title A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
Purpose  The purpose of this study is to determine the effectiveness of nivolumab adjuvant
immunotherapy compared to placebo in adults and pediatric participants after complete
resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for
recurrence.
Lay Summary  N/A
WA Trial SItes  Medical Oncology Ph. (08) 6383 3000
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

GO40558

Registered Title A Phase II, Open-Label, Multicenter, Randomized Study Of The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab In Patients With Previously Untreated Advanced Melanoma
Purpose  This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported
outcomes (PROs) of RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients
with previously untreated advanced melanoma.
Lay Summary  N/A
WA Trial Sites  Ph. (08) 6465 9204
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CA224-020

Registered Title A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Purpose The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

BGB-900-103

Registered Title A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Purpose  This is an open-label, multicenter, non-randomized Phase 1b clinical trial for patients with histologically or cytologically confirmed locally advanced or metastatic tumors including non- squamous NSCLC, RCC, or OC.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CA224-048

Registered Title A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
Purpose  The purpose of this study is to investigate safety and anti-tumor activity of relatlimab combination therapy in solid cancers that are advanced or have spread
Lay Summary  N/A
WA Trial Sites

 Linear Clinical Research ph. 08 6382 5513

Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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  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  Ph. 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  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  ph. (08) 6151 1061
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

 Cancer Centre Clinical Trials Unit  Ph. (08) 615 26530

 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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