Clinical trials

Clinical trials

If you're interested in participating in the molecular screening and therapeutics clinical trials, read through the tabs below. 

For questions about the program, please email: gcmp@garvan.org.au

  • Our staff will get back to you as soon as possible, but as demand is quite high for information about these programs, please allow a day or two  to process your request.
  • HOW IT WORKS
  • MoST CLINICAL TRIALS
  • MoST IMMUNOTHERAPY TRIALS

Eligibility for participation in Molecular Screening and Therapeutics (MoST) clinical trials is independent of where the cancer arises in the body, as MoST personalises experimental treatment based on an individual’s unique personal and cancer genetic profile. In these trials, rather than focusing on a tumour’s location, such as the ovaries, patients with say ovarian cancer, pancreatic cancer, sarcoma and other cancers, but who have a shared harmful variant, are treated with a drug that may target the variant.

Clinical trials are generally used to test a new treatment, with some patients getting the new drug and the others getting an existing drug or a placebo. One third of GCMP patients will have a biomarker matched to a targeted therapy, while those remaining may be directed onto other trials or therapies, including immunotherapies. 

The clinical trial process

Traditionally, clinical trials for new drugs have been conducted in four to five phases, taking around eight to ten years to complete. The financial costs of conducting cancer clinical trials have risen from less than US$10,000 per patient in 1980, to around $US47,000 in 2011. 

Because there are fewer patients with rare cancers, it isn’t possible to follow the usual progression of clinical trials mechanisms for these small groups of patients.

While phase 1, 2 and 3 studies are, and will remain, critical to drug development, they are costly and slow. New trial designs, such as the MoST clinical trials, which sit between a phase 1 toxicity trial and a phase 2 efficacy trial and include genetic testing of cancers, offer opportunities for trialling targeted treatments.

Joining the MoST clinical trial

First, all patients (and their tumours where possible) are genomically screened to see if they're suitable and if there are variants that can guide the treatments. These trials are looking to see if a treatment will work, or work more effectively than another treatment.

After screening, patients are offered either:

  1. MoST clinical trials, including immunotherapies
  2. Clinical trials outside MoST that use molecular eligibility criteria
  3. Other biomarker-guided treatments outside MoST.

All participants, including those with no ‘actionable’ biomarkers are informed of the results of the screening through their own doctors.

MoST has already shown that genomic cancer profiling can identify treatable options for a significant portion of patients who previously had none.

 

Precision Cancer Immunotherapy

The MoST protocol is also conducting clinical studies to test new immunotherapy drugs in patients with high-mortality cancers. The first MoST immunotherapy substudy tests a combination of so-called ‘immune checkpoint inhibitor’ drugs that take the brakes off the anti-tumour immune response, enabling immune cells to attack cancer cells. A second immunotherapy study, for patients with specific genetic abnormalities in their tumour, combines a targeted treatment with a checkpoint inhibitor.

Although immunotherapies are proving to be effective in many cancer types, they do not work in all patients. We're looking to find biomarkers that can predict which patients will benefit from specific treatments targeting the immune system, and to better understand how immunotherapies work to fight cancer. With this knowledge, we aim to develop a more precise approach that tailors treatment with immunotherapy to individual patients based on the characteristics of their immune system and its interactions with tumour cells.

The immunotherapy trials will allow us to understand how these immune biomarkers influence the anti-tumour response, and help develop a precision approach where treatment can be personalised.

Disclaimer

All component studies of the Genomic Cancer Medicine Program have been approved by the St Vincent’s Hospital Sydney Human Research Ethics Committee, which operates under the requirements of the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007), the Australian Code for the Responsible Conduct of Research (2007), and for research specific to NSW, the NSW Supplement to the National Statement (2008).