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.
CHARLI
| Registered Title | A Phase Ib/II Trial of Ipilimumab-Nivolumab-Denosumab and Nivolumab-Denosumab in Patients With Unresectable Stage III and IV Melanoma |
| Purpose | The purpose of this project is to test the addition of a new treatment called denosumab to standard immunotherapies for patients with metastatic melanoma. Denosumab has been used for many years to help treat cancers such as prostate cancer and breast cancer, but it is not currently used in melanoma. We hope the addition of denosumab to current melanoma therapies will make these treatments work better without adding to the side effects.
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| Lay Summary | Study details: Nivolumab and ipilimumab are approved treatments for advanced melanoma in Australia and overseas. Patients with metastatic melanoma, who are not enrolled in a study, are commonly prescribed nivolumab alone or the combination of nivolumab and ipilimumab as standard care. However, there is limited information on the effectiveness and safety of these treatments in combination with denosumab. Recent melanoma research in animal models has shown that denosumab can make immunotherapies such as ipilimumab and nivolumab work better. Because denosumab has been used in patients with breast and prostate cancer for a long time and is safe, we now want to test the benefits and safety of adding denosumab to immunotherapies in this study. |
| WA Trial Summary |  Medical Oncology Ph. (08) 6383 3000 |
| Links | US National Library of Medicine |
Acknowledgements: US National Library of Medicine
CA045-001
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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 |  Ph. 08 6382 5513
|
| Links | US National Library of Medicine |
Acknowledgements: US National Library of Medicine
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 |
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 |
| 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 |
| Lay Summary | N/A |
| WA Trial SItes | Cancer Centre Clinical Trials Unit Ph. 08 615 26530 |
| Links | 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 |
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| 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
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 |
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| Links | US National Library of Medicine |
Acknowledgements: US National Library of Medicine
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