Head and Neck Cancer

Clinical trials for patients with cancer of the mouth, nose, throat, tonsils, voice box or thyroid. This also includes cutaneous squamous cell carcinoma.

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 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

On hold

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 safety and effectiveness of the treatment REGEN2810 (Cemiplimab) in patients with cutaneous squamous cell cancer

Cancer type

Cutaneous squamous 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

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 Selpercatinib in patients with thyroid cancer that have specific changes in the genes of the cancer (RET activation)

Cancer type

Thyroid cancer with specific changes in the genes of the cancer (RET activation)

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 is to find the best dose of the new treatment and see if it works against the cancer.

Brief summary

A clinical trial to test the safety and effectiveness of the new treatment Selpercatinib and the best dose of the treatment for patients with thyroid cancer that have specific changes in the genes of the cancer called ‘Rearranged During Transfection’ or RET activation. RET is a gene that is involved in the normal development of cells. If the RET gene changes it can change the way normal cells develop which can lead to cancer. The treatment Selpercatinibis aims to stop the RET gene from working, which may stop, slow, or reverse the growth of the cancer.The clinical trial will test if the treatment can shrink the cancer or stop the cancer from growing.

Who can participate

Patients who:

  • Have cancer with specific changes in the genes of the cancer (RET fusion)
  • Have cancer that has spread to other parts of the body
  • Have had treatment for their cancer but it has gotten worse or have not responded to treatment given 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.

An expanded access program which allows patients with solid cancers (cancer in the ‘solid’ organs such as breast or lung) to access the treatment Selpercatinib

Cancer type

Solid cancer with specific changes in the genes of the cancer (RET activation)

Status

Open and recruiting

Phase

Expanded access (also called 'compassionate use'), allows patients to access new treatments and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions that would not normally be available to them.

Brief summary

The expanded access program gives access for patients to the treatment Selpercatinib which is not yet accessible in Australia outside of a clinical trial. Patients with solid cancers who have specific changes in the genes of the cancer called ‘Rearranged During Transfection’ or RET activation are suitable. RET is a gene that is involved in the normal development of cells. If the RET gene changes it can change the way normal cells develop which can lead to cancer. The treatment Selpercatinibis aims to stop the RET gene from working, which may stop, slow, or reverse the growth of the cancer.

Who can participate

Patients who:

  • Have RET activation
  • Have cancer that has grown outside the body part it started in but has not yet spread to other parts of the body, or have cancer that has spread to other parts of the body
  • Are not able to access Selpercatinib through a clinical trial

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.

A clinical trial to test if the treatment Selpercatinib is better than Cabozantinib or Vandetanib in patients with Medullary Thyroid Cancer, with specific changes in the genes in the cancer

Cancer type

Medullary thyroid cancer

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 clinical trial will test the safety and effectiveness new treatment Selpercatinib to treatments Cabozantinib or Vandetanib. The aim of the clinical trial is to test if Selpercatinib is better than these available treatments. Patient with medullary thyroid cancer who have specific changes in the genes of the cancer called ‘Rearranged During Transfection’ or RET activation are suitable. RET is a gene that is involved in the normal development of cells. If the RET gene changes it can change the way normal cells develop which can lead to cancer. The treatment Selpercatinibis works to stop the RET gene from working, which may stop, slow, or reverse the growth of the cancer.

Who can participate

Patients who:

  • Have RET activation
  • Have not been treated this type of treatment before

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 the new treatment DB-020 for patients receiving high dose cisplatin

Cancer type

Patients receiving high dose cisplatin

Status

Open to recruitment

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 test if the treatment DB-020 is effective in reducing any possible hearing loss side effects that the chemotherapy treatment Cisplatin may have in treating patients with cancer. Patients will be closely monitored by a team of oncologists and hearing experts. The treatment DB-020 will be given for at least 3 cycles.

Who can participate

Patients who:

  • Have cancer
  • Treatment plan consists of Cisplatin

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 articipate

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.