Melanoma and Skin Cancer

Clinical trials for patients with skin cancer. Including basal cell carcinoma, merkel cell carcinoma and melanoma.

If you would like to be considered for a clinical trial you will require a referral from your current treating team. Visit the Joining a Clinical Trial page for referral information. 

For more information on clinical trials, get in contact with our cancer clinical trials enquiry coordinator.

Clinical Trials Enquiry Coordinator

Business hours, Mon to Friday between 9am - 2pm
Email [email protected]
Phone (03) 8559 7456

Open and Recruiting Clinical Trials

A clinical trial to test the safety and effectiveness of a the treatment Denosumab given together with standard immunotherapy treatments available for patients with melanoma

Cancer type

Melanoma

Status

Open and recruiting

Phase

One/two: A phase one / two clinical trial combines a phase one and two. The phase one tests new treatments sometimes for the first time in humans, usually in a small group of patients. The phase two part tests the new treatment in a larger group of patients with selected cancer types. The aim of a phase one / two test for the new treatment to find the best dose and find effective in these cancer types.

Brief summary

Ipilimumab and Nivolumab are types of treatment called immunotherapy used to treat melanoma. Immunotherapies work with the body’s immune system to help stop cancer cells growing. Denosumab is used to treat other cancer types, but has not been tested in melanoma. Denosumab works by blocking the specific cells which slow the body’s immune response to the cancer. The aim of the clinical trial is to see if the addition of Denosumab to the standard immunotherapies given for melanoma will improve the outcome on the body’s immune system to fight cancer.

Who can participate

Patients who:

  • Have cancer that has spread to other parts of the body
  • Are unable to have surgery to remove the cancer

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial. 

A clinical trial to test the safety and effectiveness of the treatment Palbociclib given with Encorafenib and Binimetinib in patients with melanoma with specific changes in the genes of the cancer (BRAF V600 mutation) that has spread to other parts of the body

Cancer Type

Melanoma with a BRAF V600 mutation

Status

Open and recruiting

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one is to test the safety of the new treatment and find the best dose to give patients.

Brief summary

The aim of this clinical trial is to test the safety and effectiveness of giving Palbociclib with Encorafenib and Binimetinib in patients with melanoma who have BRAF V600 changes in the genes of the cancer. These treatments target the immune system to reduce the cancer in the body. The clinical trial will test if the combined treatment can shrink the cancer or stop the cancer from growing.

Who can participate

Patients who:

  • Have BRAF V600 mutation
  • Are unable to have surgery to remove the cancer
  • Have cancer that has spread to other parts of the body

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test if the treatment NKTR-214 given with Nivolumab is better than Nivolumab given alone in patients with Melanoma that has spread to other parts of the body or cannot be removed through surgery

Cancer type

Melanoma

Status

Open and recruiting

Phase

Three: A phase three clinical trial follows a phase two, in a larger group of patients with specific cancer types. The aim of a phase three is to compare the new treatment to what is available for that cancer type

Brief summary

A clinical trial to test if the treatment NKTR-214 given with Nivolumab is better than Nivolumab given alone in patients with melanoma. The aim of the clinical trial is to test if the treatment NKTR-214 given with Nivolumab can shrink the cancer or stop the cancer from growing better than Nivolumab when given alone. The treatments NKTR-214 and Nivolumab work by targeting the immune system to reduce the cancer size.

Who can participate

Patients who:

  • Have melanoma that has spread to other parts of the body
  • Have not had any treatment for their cancer

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial. 

A clinical trial for patients with melanoma that has spread near to or into the lymph nodes to test if giving treatment combinations before surgery will make surgery easier and improve outcomes after surgery

Cancer type

Melanoma with specific changes in the genes of the cancer (BRAF V600 mutation)

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

The aim of the clinical trial is to test if giving treatment combinations before surgery can shrink the melanoma making the surgery easier and reducing the chance of the melanoma coming back. The clinical trial also includes treatment after surgery, with the aim to further reduce the possibility of the melanoma returning. Patients with specific changes in the genes of the cancer (BRAF V600 mutation) are suitable for this clinical trial. BRAF V600 can increase the growth and spread of cancer cells. Patients on the clinical trial will be randomly selected to receive one of the following treatment combinations:

Arm 1:

  • Before surgery: dabrafenib and trametinib orally for seven days, in combination with two cycles of pembrolizumab (immunotherapy) given through the veins every 3 weeks
  • After surgery: pembrolizumab given through the veins once every three weeks for up to 18 cycles

Arm 2:

  • Before surgery: dabrafenib and trametinib orally for 42 days, in combination with two cycles of pembrolizumab given through the veins every 3 weeks
  • After surgery: pembrolizumab given through the veins once every three weeks for up to 18 cycles

Arm 3:

  • Before surgery: two cycles of pembrolizumab given through the veins once every 3 weeks
  • After surgery: pembrolizumab given through the veins once every three weeks for up to 18 cycles
Who can participate

Patients who:

  • Have cancer that can be completely removed with surgery
  • Have cancer with BRAF V600 mutation

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial. 

A clinical trial to test if Ipilimumab and Nivolumab (immunotherapy) given with or without radiotherapy to brain metastases is best for patients with melanoma that has spread to the brain

Cancer type

Melanoma

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

The aim of this clinical trial is to test the safety and effectiveness of two treatment combinations for patients with melanoma that has spread to the brain. Nivolumab and Ipilimumab are types of treatment called immunotherapy, which works with your immune system to help stop cancer cells growing. The type of radiotherapy given in this clinical trial is called stereotactic radiotherapy or SRS. SRS works by only treating the cancer cells and not healthy areas of the brain.  

Who can participate

Patients who:

  • Have metastatic melanoma that has spread to the brain

  • Have not previously had radiotherapy or immunotherapy to treat the brain metastases

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial. 

A clinical trial to test if the treatment Nivolumab (a type of immunotherapy) given with a personalised cancer vaccine (PCV) is better than Nivolumab alone in patients whose melanoma has been surgically removed

Cancer type

Melanoma

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

The aim of this clinical trial is to test the safety and effectiveness of Nivolumab (immunotherapy) given with a personalised cancer vaccine (PCV) compared to Nivolumab alone in patients whose melanoma has been surgically removed. PCV are made by using the patient’s tumour material to identify specific proteins that may help the immune system recognise the cancer cells as bad. These are then made into a personalised vaccine that is given with Nivolumab to help your immune system recognise and attack the cancer cells.

Who can participate

Patients who:

  • Have melanoma that has been completely removed with surgery

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial. 

A clinical trial to test the safety and effectiveness of RO7198457 (a personalised cancer vaccine) given with Pembrolizumab and to test if this combination is better than Pembrolizumab given alone in patients with metastatic melanoma

Cancer type

Melanoma

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

RO7198457 is a type of treatment called personalised cancer vaccine (PCV). PCV are made by using the patient’s tumour material to identify specific proteins that may help your immune system recognise the cancer cells as bad. These are then made into a personalised RNA vaccine that is given with Pembrolizumab (a type of immunotherapy) to help your immune system recognise and attack the cancer cells.

To test this, patients will be randomly selected to receive either of the following:

Arm 1: RO7198457 given with Pembrolizumab

Arm 2: Pembrolizumab given alone

Who can participate

Patients who:

  • Have cancer that cannot be removed by surgery
  • Have cancer that has spread to other parts of the body
  • Have not previously been treated for cancer that has spread

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial. 

A clinical trial to test the safety and effectiveness of the new treatment RO7293583 for patients with melanoma that has spread to other parts of the body

Cancer type

Melanoma

Status

Open and recruiting

Phase

One: A phase one clinical trial tests new treatments sometimes for the first time in humans, usually in a small group of patients. The aim of a phase one is to test the safety of the new treatment and find the best dose to give patients.

Brief summary

The aim of the clinical trial is to find the best dose of a new treatment RO7293583 and test the safety and effectiveness in patients with melanoma that has spread to other parts of the body. RO7293583 is a type of treatment called an antibody, which carries an immune-activating protein and joins to TYRP1-positive cancer cells. This helps the immune system to target and kill the cancer cells.

Who can participate

Patients who:

  • Have cancer that has spread to other parts of the body
  • Have TYRP1-positive cancer

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test the safety and effectiveness of the treatment Avelumab in patients with surgically removed merkel cell carcinoma

Cancer type

Merkel cell carcinoma

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

The aim of this clinical trial is to test if giving the treatment Avelumab after surgery or in combination with radiotherapy can improve outcomes for patients with early stage merkel cell carcinoma that has not spread to other parts of the body. Avelumab has shown to be effective in treating merkel cell carcinoma that has spread to other parts of the body, but has not yet been tested in early stage merkel cell carcinoma. For patients where surgery is the best option, Avelumab will be given after surgery once every 2 weeks for 6 months. For patients where radiotherapy is the best option as well as or instead of surgery, Avelumab will be given in combination with radiotherapy.

Who can participate

Patients who:

  • Do not have cancer that has spread to other parts of the body

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial. 

A clinical trial to test the safety and effectiveness of the treatment Avelumab given with either radiotherapy or Lutate for patients with merkel cell carcinoma that has spread to other parts of the body

Cancer type

Merkel cell carcinoma

Status

Open and recruiting

Phase

One/two: A phase one / two clinical trial combines a phase one and two. The phase one tests new treatments sometimes for the first time in humans, usually in a small group of patients. The phase two part tests the new treatment in a larger group of patients with selected cancer types. The aim of a phase one / two test for the new treatment to find the best dose and find effective in these cancer types.

Brief summary

A clinical trial to test if giving Avelumab in combination with radiotherapy or Lutate is better than giving these treatments alone and can improve outcomes for patients with merkel cell carcinoma. Avelumab is a type of treatment called immunotherapy, which works with the immune system to help stop cancer cells growing. Patients on clinical trial will be assessed by the somatostatin receptor status. If their status is negative, they will be assigned to Arm A. If their status is positive, they will be randomised to either Arm B or C:

Arm 1: (somatostatin receptor negative): avelumab and radiotherapy

Arm 2: (somatostatin receptor positive): avelumab and radiotherapy

Arm 3: (somatostatin receptor positive): avelumab and Lutate

Who can participate

Patients who:

  • Have not received treatment for their cancer
  • Have cancer that has spread to other parts of the body

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial. 

A clinical trial to test the safety and effectiveness of the treatment REGEN2810 (Cemiplimab) in patients with cutaneous squamous cell cancer

Cancer type

Cutaneous squamous cell cancer

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

A clinical trial to test the safety and effectiveness of the treatment Cemiplimab in patients with cutaneous squamous cell cancer. Cemiplimab is a type of treatment called a monoclonal anti-PD-1 antibody that work by stopping specific proteins that stop the body’s natural immune system from attacking cancer cells. Stopping these proteins is expected to help immune cells attack cancer cells.

Who can participate

Patients who:

  • Have had treatment for their cancer but it has gotten worse or has not responded to treatment
  • Are not able to have surgery
  • Are not able to have radiotherapy

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test safety and effectiveness of the treatment REGEN2810 (Cemiplimab) in patients with cutaneous squamous cell cancer and if giving Cemiplimab before surgery has an effect on cancer free survival after surgery

Cancer type

Cutaneous squamous cell cancer

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

The clinical trial will test the treatment Cemiplimab on patients with cutaneous squamous cell cancer who are candidates for surgery. Cemiplimab is a type of treatment called a monoclonal anti-PD-1 antibody that work by stopping specific proteins that stop the body’s natural immune system from attacking cancer cells. Stopping these proteins is expected to help immune cells attack cancer cells. Four treatments of Cemiplimab will be given before surgery.

Who can participate

Patients who:

  • Are eligible for surgery

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test the safety and effectiveness of the treatment REGEN2810 (Cemiplimab) for patients with cutaneous squamous cell carcinoma after standard treatment with surgery and radiation therapy

Cancer type

Cutaneous squamous cell cancer

Status

Open and recruiting

Phase

Three: A phase three clinical trial follows a phase two, in a larger group of patients with specific cancer types. The aim of a phase three is to compare the new treatment to what is available for that cancer type.

Brief summary

The clinical trial will test the treatment Cemiplimab is better than the standard treatment given after surgery and radiotherapy. Cemiplimab is a type of treatment called a monoclonal anti-PD-1 antibody that work by stopping specific proteins that stop the body’s natural immune system from attacking cancer cells. Stopping these proteins is expected to help immune cells attack cancer cells.

Who can participate

Patients who:

  • Have not had been treated with immunotherapy before
  • Have had surgery followed by radiotherapy for their cancer

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test the safety and effectiveness of the new treatment GSK3359609 (Feladilimab) in patients with head and neck cancer

Cancer type

Head and neck squamous cell carcinoma

Status

Open and recruiting

Phase

One: A phase one clinical trial test new treatments, sometimes for the first time in humans, usually in a small group of patients. The aim is to test the safety of the new treatment and find the best dose to give patients.

Brief summary

A clinical trial to find the best dose of the new treatment Feladilimab, a type of treatment called immunotherapy in patients who have had treatment for their head and neck cancer but it has gotten worse or not responded to previous treatment given. Immunotherapy treatments work with your immune system to help stop cancer cells growing. This trial has two treatment groups. Different amounts of Feladilimab are given in each group. You will be selected for only one group. Both groups will also be given the treatment Pembrolizumab.

Who can participate

Patients who:

  • Have had treatment for their cancer but it has gotten worse or have not responded to treatment given
  • Cancer that has spread to other parts of the body after receiving standard treatment

Clinical trials can have very strict rules of who can and can’t take part. Talk to your doctor if you are interested in this clinical trial.

A clinical trial to test if the new treatment, GSK3359609 (Feladilimab) given with Pembrolizumab is better than the standard treatment available as first treatment for patients with head and neck squamous cell cancer that has returned or spread to other parts of the body

Cancer type

Head and Neck Squamous Cell Cancer

Status

Open and recruiting

Phase

Two/three: A phase two and three clinical trials follow a phase one/two, in a larger group of patients with specific cancer types. The aim of a phase two/three is to compare the new treatment to what is available for that cancer type and closely monitor patients to make sure the treatment is safe and effective in that cancer type.

Brief summary

A clinical trial to test the safety and effectiveness of the treatment Feladilimab given with Pembrolizumab compared to Pembrolizumab given with placebo (a pill or liquid that contains no treatment) in patients with head and neck squamous cell cancer that has that has returned or spread to other parts of the body. Treatment will be given for up to 2 years. The clinical trial will look at how symptoms from cancer affect patients’ health and quality of life.

Patients on clinical trial will receive either of the following:

Arm 1: Feladilimab given with Pembrolizumab

Arm 2: Placebo given with Pembrolizumab

Who can participate

Patients who:

  • Have cancer that has spread to other parts of the body
  • Have cancer that is positive for a specific protein (PD-L1)

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test if new treatment, GSK3359609 (Feladilimab) given with Pembrolizumab and standard chemotherapy is better than Pembrolizumab given with standard chemotherapy for patients with head and neck squamous cell cancer that has returned or spread to other parts of the body

Cancer type

Head and neck squamous cell cancer

Status

Open to recruitment

Phase

Two/three: A phase two and three clinical trials follow a phase one/two, in a larger group of patients with specific cancer types. The aim of a phase two/three is to compare the new treatment to what is available for that cancer type and closely monitor patients to make sure the treatment is safe and effective in that cancer type.

Brief summary

The aim of this clinical trial is to test if the standard treatment combination of Pembrolizumab and standard chemotherapy is more effective when given with the new treatment Feladilimab. Patients will be randomly selected to receive one of the following:

Arm 1: Feladilimab given with Pembrolizumab and standard chemotherapy

Arm 2: Placebo (a pill or liquid that contains no treatment) given with Pembrolizumab and standard chemotherapy

Treatment will be given for up to 2 years. The clinical trial will look at how symptoms from cancer affect patients’ health and quality of life.

Who can participate

Patients who:

  • Have head neck squamous cell cancer of the mouth and/or throat
  • Have cancer that has come back and/or spread to other parts of the body

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test the treatment Cemiplimab given with or without RP1 for patients with cutaneous squamous cell cancer who have had treatment for their cancer but it has gotten worse or have not responded to treatment given

Cancer type

Cutaneous squamous cell cancer

Status

Open to recruitment

Phase

Phase Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

A clinical trial to compare the safety and effectiveness of the treatment Cemiplimab given with or without RP1. Cemiplimab is a type of treatment called a monoclonal anti-PD-1 antibody that work by stopping specific proteins that stop the body’s natural immune system from attacking cancer cells. Stopping these proteins is expected to help immune cells attack cancer cells. RP1 is a type of anti-cancer virus given by injection. Patients on clinical trial will receive either of the following:

Arm 1: Cemiplimab

Arm 2: Cemiplimab given with RPI

Who can participate

Patients who:

  • Have had treatment for their cancer but it has gotten worse or have not responded to treatment given

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test the safety and effectiveness of new treatment Monallizumab given with Cetuximab for patients with squamous cell carcinoma of the head and neck that has come back or spread to other parts of the body

Cancer type

Squamous cell carcinoma of the head and neck

Status

Opening and recruiting

Phase

Three: A phase three clinical trial follows a phase two, in a larger group of patients with specific cancer types. The aim of a phase three is to compare the new treatment to what is available for that cancer type

Brief summary

This clinical trial will test if the treatment Monolizumab when given with Cetuximab is better at slowing the growth of head and neck cancer than Cetuximab given on its own in. Patients on clinical trial will receive either of the following:

Arm 1: Monolizumab given with Cetuximab

Arm 2: Placebo (pill or liquid that contains no treatment) given with Cetuximab

Who can participate

Patients who:

  • Have been treated with chemotherapy and immunotherapy (a type of treatment which works with your immune system to help stop cancer cells growing)
  • Have had treatment for their cancer but it has gotten worse or not responded to treatment given
  • Have cancer that has spread to other parts of the body

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test the safety and effectiveness of the treatment DEBIO1143 given with chemotherapy and radiotherapy in patients with squamous cell carcinoma of the head and neck

Cancer type

Squamous cell carcinoma of the head and neck

Status

Opening Soon

Phase

Three: A phase three clinical trial follows a phase two, in a larger group of patients with specific cancer types. The aim of a phase three is to compare the new treatment to what is available for that cancer type

Brief summary

The aim of the clinical trial is to test if the treatment DEBIO1143 given with chemotherapy and radiotherapy is better and can stop the cancer from returning for longer period of time than chemotherapy and radiotherapy given alone. Patients on clinical trial will receive either of the following:

Arm 1: DEBIO1143 given with radiotherapy and chemo

Arm 2: Placebo (pill or liquid that contains no treatment) given with radiotherapy and chemo

Who can participate

Patients who:

  • Have not been previously treated for their cancer
  • Patients who are suitable for treatment with chemotherapy and radiotherapy
  • Have cancer that has grown outside the body part it started in but has not yet spread to other parts of the body

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.

A clinical trial to test the safety and effectiveness of the treatment Tipifarnib for patients with squamous cell carcinoma of the head and neck with specific changes in the genes of the cancer (HRAS mutations)

Cancer type

Squamous cell carcinoma of the head and neck

Status

Open and recruiting

Phase

Two: A phase two clinical trial follows a phase one, in a large group of patients with selected cancer types. The aim of a phase two is to find out if the new treatment is effective in these cancer types.

Brief summary

The clinical trial is testing the new treatment, Tipifarnib for squamous cell carcinoma of the head and neck with specific changes in the genes of the cancer called HRAS mutations. In HRAS mutant cancers, the HRAS proteins can cause normal cells in the body to grow uncontrollably and become cancer cells. Tipifarnib aims to turn off the HRAS mutant protein and stop the growth of cancer cells.

Who can participate

Patients who:

  • Have changes in the genes of the cancer (HRAS mutation)

Clinical trials can have restrictive criteria of who can and can’t participate, talk to your doctor if you are interested in this clinical trial.