Head and Neck

The following list provides a brief description of head and neck 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.

 

CA209-651 Study

Registered Title

An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).

Purpose

The main purpose of this study is to compare nivolumab and ipilimumab with the Extreme study regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer.

Lay Summary

N/A

WA Trial Sites

Sir Charles Gairdner Hospital Logo

SCGH Medical Oncology
Ph. (08) 6383 3000

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

HPV Oropharynx (TROG 12.01)

Registered Title

HPV Oropharynx: A Randomised Trial of Weekly Cetuximab and Radiation versus Weekly Cisplatin and Radiation in Good Prognosis Locoregionally Advanced HPV-Associated Oropharyngeal Squamous Cell Carcinoma (TROG 12.01).

Purpose

This study aims to compare radiation treatment (RT) combined with either cetuximab or cisplatin in patients with locoregionally advanced HPV positive oropharyngeal squamous cell carcinoma (OPSCC) (located at the base of tongue or tonsil).

The main aim of the study is to compare the severity of symptoms between weekly cisplatin and RT versus weekly cetuximab and RT. 

Lay Summary

A standard treatment for patients with cancer of the base of tongue or tonsil that is associated with HPV is radiation given with a chemotherapy drug called cisplatin. Cisplatin may be given in high doses every 3 weeks or in lower doses weekly during radiation treatment. The high dose and low dose schedules result in a similar total dose of cisplatin being given during the radiation, but it is thought that the weekly schedule results in fewer side effects while maintaining effectiveness and will be used in this trial.

Another approach widely used around the world for patients with head and neck cancer, is to administer the antibody, cetuximab, weekly during radiation. Cetuximab is an antibody which attaches to a receptor on cancer cells. Cetuximab has a very different side effect profile to cisplatin, and has been reported to result in less exacerbation of radiation related side effects. Both cetuximab and cisplatin can reduce the growth of a cancer and increase the effectiveness of radiation. In Australia cetuximab is approved for use in your type of cancer with radiation, though it is only available on the pharmaceutical benefits scheme if you cannot be given cisplatin. All patients being considered for this trial will be deemed to be fit to receive either cisplatin or cetuximab.

Both cisplatin and cetuximab appear to be effective treatments in combination with radiation, but have not been directly compared.  It is anticipated that both approaches will achieve high rates of control of your type of cancer. The purpose of this study is to compare the treatment related side effects (both acute and longer term) between the cisplatin and cetuximab regimens. Both treatments would be given with the same dose of radiation therapy over 7 weeks. The results of this trial will help determine the optimal treatment for patients with your type of cancer. 

This research is being conducted by the Trans-Tasman Radiation Oncology Group (TROG).

WA Trial Sites     

Sir Charles Gairdner Hospital logo                                

SCGH Radiation Oncology
Ph. (08) 6383 3000

Links

TROG Cancer Research trial 12.01

 

REGENERON Study

Registered Title

A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma.

Purpose

To estimate the clinical benefit of REGN2810 monotherapy for patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Group 1) or with unresectable locally advanced CSCC (Group 2), as measured by overall response rate (ORR), according to central review.

Lay Summary

N/A

WA Trial Sites

Sir Charles Gairdner Hospital Logo

SCGH Medical Oncology
Ph. (08) 6383 3000

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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