Skin cancer

The 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.

 

CheckMate 401 (CA209-401) Study

Registered Title

Clinical Trial of Nivolumab (BMS-936558) Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma CheckMate 401: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 401.

Purpose

The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.

Lay Summary

N/A

WA Trial Sites

St John of God Murdoch Logo

Tamsyn Whitcher
Murdoch Oncology Clinical Trials Unit
Ph. (08) 9428 8539
oncologytrials.murdoch@sjog.org.au

Sir Charles Gairdner Hospital Logo

SCGH Medical Oncology
Ph. (08) 6383 3000

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

MASTERKEY 265 Study

Registered Title

A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265).

Purpose

Phase 1b Subjects will be treated with talimogene laherparepvec until all injectable tumors have disappeared, disease progression per modified Immune-Related Response Criteria (irRC), or intolerance of study treatment, up to a maximum of 24 months of study treatment. Subjects will be treated with MK-3475 (pembrolizumab) until complete response (CR) disease progression per irRC, or intolerance of study treatment, up to a maximum of 24 months of study treatment. In Phase 3, Subjects will be treated with talimogene laherparepvec plus pembrolizumab(arm 1) or placebo plus pembrolizumab (arm 2) until 24 months from the date of the first dose of pembrolizumab or end of treatment due to disappearance of injectable lesions, complete response, disease progression per irRC-RECIST or intolerance of study treatment.

Lay Summary

N/A

WA Trial Sites

Fiona Stanley Hospital Logo

Cancer Centre Clinical Trials Unit
Caroline Stone
Clinical Trials Manager
Phone 08 615 26530 Fax 08 615 20954
caroline.stone@health.wa.gov.au

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

TACTI-mel Study

Registered Title

A Multicentre, Open Label, Dose Escalation, Phase 1 Study in Patients With Unresectable or Metastatic Melanoma Receiving IMP321 (LAG-3Ig Fusion Protein) as an Adjunctive Therapy to Anti-PD-1 Therapy With Pembrolizumab.

Purpose

The purpose of this study is to determine the safety, tolerability and recommended phase 2 dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma.

Lay Summary

N/A

WA Trial Sites

Fiona Stanley Hospital Logo

Cancer Centre Clinical Trials Unit
Caroline Stone
Clinical Trials Manager
Phone 08 615 26530 Fax 08 615 20954
caroline.stone@health.wa.gov.au

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

DV3-MEL-01/Keynote 184

Full Title

A Phase 1b/2, Open-label, Multicenter, Dose escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.

Description

This is open-label, multicenter trial is designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD 101 injections in combination with intravenous pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Phase 2 of this study will consist of 2 expansion cohorts to further evaluate the efficacy and safety of SD-101. The two separate cohorts are those who are anti-programmed death receptor-1/ligand 1 (anti-PD-1/L1) therapy naïve and those who have progressive disease (PD) while receiving anti-PD-1/L1 therapy.

 

Inclusion Criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Provide tissue for PD-L1 biomarker analysis from a newly obtained biopsy obtained within 28 days of enrolment.
  • Histologically or cytologically confirmed recurrent or metastatic HNSCC that could not be treated with curative intent.
  • Have at least 1 measurable site of disease (target lesion per RECIST 1.1, which must be accessible and amenable to multiple intratumoral injections. If superficial, the lesion must measure at least 10 mm in diameter, measured by calipers, and be documented photographically.
  • Recurrent or metastatic HNSCC patients with PD while receiving anti-PD-1/L1 therapy must have documented PD per RECIST 1.1 while receiving anti-PD-1/L1 therapy and must have received anti-PD-1/L1 agent within 6 weeks of study enrolment.

 

Exclusion Criteria
  • Is expected to require any other form of anti-cancer therapy while in the trial.
  • Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
  • History of or current uveal or ocular melanoma.
  • Active infection including cytomegalovirus.
  • Active autoimmune disease requiring systemic treatment in the past 2 years or a disease that requires immunosuppressive medication including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Current pneumonitis or history of (non-infectious) pneumonitis that required steroids.
  • Known active central nervous system metastases or carcinomatous meningitis.
  • Use of any investigational agent within the last 28 days prior to study enrollment.
  • Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
  • Any known additional malignancy that is progressing or requires active treatment (except for melanoma).

 

 

 

Contact

Affinity Oncology Logo

 

 

 

 

Affinity Clinical Research
Monash Ave, Nedlands
(08) 9446 8726

Status

Open to Recruitment

Principal Investigator

Alex Powell
apowell@affinityresearch.com.au

Trial Coordinator

Krys Hiscock
pm1@affinityresearch.com.au

 

 

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