Partnering with cooperative groups such as the AGITG the Gibbs Lab is now managing all aspects of clinical trial management for a number of interventional studies. The collaborative group members are medical oncologists that work across a number of participating institutions who have worked together to design, conduct and analyse clinical studies. The projects required clinical trial infrastructure support such as protocol review, database build and support, drug management, safety reporting. All aspect of this are offered by the Gibbs Lab coordinating centre. This work is being led by Associate Professor Jeanne Tie with clinical support from Dr Shehara Mendis and Dr Wei Hong, project management support from Tina Cavicchiolo and Thy Nguyen. RESOLUTE : Randomised Phase II Trial to Evaluate the Strategy of Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal CancerContact: rmh-resolute@mh.org.auNEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer, NEO-IMPACT. contact neo-impact@mh.org.auhttp://www.anzctr.org.au/https://gicancer.org.au/clinical-trial/status/open/

Prof Peter Gibbs, Lab Head | WEHI Researcher Profile

Q: Blood biomarker studies

A reliable biomarker of minimal residual disease could have a major impact on adjuvant therapy decision making and the development of new adjuvant treatments. Our initial studies in colorectal cancer and pancreatic cancer have shown that circulating tumour DNA (ctDNA) is a powerful prognostic biomarker. Patients with detectable ctDNA after curative intent surgery have been shown to have a markedly elevated risk of recurrence (well in excess of the average for that patient population), whereas patients with no detectable ctDNA have a much lower risk of recurrence (much less that the average for that patient population). Prospective randomized studies are exploring the potential of a ctDNA directed approach to adjuvant therapy whereby patients with detectable ctDNA have treatment intensified and those with undetectable ctDNA have less intense treatment. World first randomized studies have completed recruitment (stage II colon cancer) or are ongoing (stage III colon cancer, locally advanced rectal cancer and pancreatic cancer). An observational study has been completed in ovarian cancer. Contact: DYNAMIC-RECTAL@mh.org.auDYNAMIC-III@mh.org.auDYNAMIC-P@mh.org.auDynamic-Ovarian@mh.org.auhttp://www.anzctr.org.au/Results from the Dynamic II study have been recently published. Recently publlished from the ASCO 2022 https://www.asco.org/about-asco/press-center/news-releases/liquid-biopsy-can-help-identify-need-adjuvant-therapy-stage-ii

Q: Organoids and tissue culture

Organoids are three dimensional models derived from patient tissue taken from tumour resections that mimic the function and structure of the cancer. Using these laboratory models, creating miniature cancers in pancreas, colorectal, head and neck, brain, derived from patient biopsies, we have partnered with other labs in the Personalised Oncology division with expertise in organoid development. The studies of patient derived tumour organoids in these specialities ultimately aims to conduct in vitro sensitivity testing and for this to be being used to guide clinical treatment selection. Each program is led by Professor Peter Gibbs with Lead Clinician assistance with Dr Lucy Gately, Dr Belinda Lee, Dr Iris Tung, Dr Shehara Mendis, Dr Grace Gard with project managment support from Helen Brasier, Catherine McKay, Kelsey Serena and Matt Chapman. All clinicians have appropriate sub-speciality expertise and substantial clinical appointments with other medical oncologists and participating centres around Melbourne and regional Victoria. The ultimate focus being clinical relevance and impact. The Gibbs Lab is partnering with other labs within the Personalised Oncology division at WEHI, such as the Seiber Lab and Putoczki Lab to undertake this work. Assessing Predictive and Prognostic Biomarkers in Pancreatic CancerEstablishing a biobank of colorectal and pancreatic cancer models for the pursuit of personalised therapiesEstablishing a BioBank of Oral Cavity Squamous Cell Carcinoma Organoids for Improving Drug Testing and TreatmentBioBrain: Brain Tumour Organoid and PDX ProjectsContact: organoids@wehi.edu.au http://www.anzctr.org.au/

About

There are five clear areas of focus for the translational research undertaken by the Gibbs Lab.

* We lead national and international cancer registries that capture comprehensive patient, tumour, treatment and outcome data for all major solid cancers. This data is used to enable audit and research, including supporting the novel concept of registry based clinical trials in oncology collection and translational research by combining data and tissue based research.

* More recently the Gibbs Lab have partnered with the Victorian Comprehensive Cancer Centre (VCCC) to undertake a number of registry-based trials. This work is ongoing with a number of new trial designs under review for inclusion as we expand the portfolio to different modalities of treatment of patients with cancer

* We lead multiple international randomised trials to define the potential of ctDNA as a marker of minimal residual disease to determine recurrence risk and to optimise adjuvant therapy.

* We have initiated studies of patient derived tumour organoids, with the ultimate aim of in vitro sensitivity testing being used to guide clinical treatment selection.

* Clinical Trials working with cooperative groups such as the AGITG and others to provide all aspects of clinical trial start up, initiation, study management to data analysis and close out.

Each program is led by a medical oncologist with appropriate sub-speciality expertise and substantial clinical appointments, with the ultimate focus being clinical relevance and impact.

Education

Joint appointments

Grants and funding

Publications

Selected publications from Prof Peter Gibbs

Drosdowsky A, Lamb KE, Marvelde LT, Gibbs P, Dunn C, Faragher I, Jones I, IJzerman MJ, Emery JD. Factors associated with diagnostic and treatment intervals in colorectal cancer: A linked data study. International Journal of Cancer. 2025;157(4):10.1002/ijc.35414

Zaman FY, Orchard SG, Polekhina G, Gibbs P, Bernstein WB, Macrae F, Tie J, Millar J, Gately L, Rodríguez LM, van Londen GJ, Mar V, Hiscutt E, Adler N, Kent A, Ong WL, Haydon A, Warner E, Chan AT, Zalcberg J. Association of non-steroidal anti-inflammatory medications and aspirin with colorectal cancer incidence in older adults. Journal of the National Cancer Institute. 2025;:10.1093/jnci/djaf145

Williams C, Inderjeeth A-J, Hong W, McKenzie J, Anton A, Weickhardt A, Wong S, Shapiro J, Parente P, Goh J, Torres J, Smith A, Joshua A, Brown S, Steer C, Johns J, Gibbs P, Tran B, Azad AA. Treatment patterns and outcomes for younger patients with metastatic castration-resistant prostate cancer (mCRPC); An Australian prospective registry study. Clinical Genitourinary Cancer. 2025;23(3):10.1016/j.clgc.2025.102345

Farbotko S, Owen A, Orchard SG, Woods RL, Nelson M, Stocks NP, Tonkin A, Wolfe R, McNeil J, Gibbs P, Zalcberg J, Ryan J. Incidence of major health events across metropolitan and regional areas: A 10+ year prospective study of 16,697 older Australians. Australasian Journal on Ageing. 2025;44(2):10.1111/ajag.70036

McLachlan S-A, Mostafa R, Sharpe L, Burge ME, Day F, Blum RH, Campbell R, Lynam JF, Lee B, Singh MS, Lee M, Chantrill LA, Lundy J, Wong ZW, Wong R, Joshi S, Saqib A, Karikios DJ, Gibbs P, Tie J. Circulating tumor DNA (ctDNA) analysis guiding adjuvant therapy in patients (pts) with colorectal cancer (CRC): Impact on fear of cancer recurrence (FCR).Journal of Clinical Oncology. 2025;43(16_suppl):10.1200/jco.2025.43.16_suppl.11125

Hecht JR, Elez E, Eng C, Gibbs P, Seligmann JF, Xu R-H, Yamaguchi K, Wang C-Y, Teng HW, Trani L, Wortman-Vayn H, Jiang Z, Diorio B, Lorenzini PA, Baudelet C, Sethi SN, Baig M, Cremolini C. OrigAMI-3: A randomized, phase 3 study of amivantamab plus FOLFIRI vs cetuximab or bevacizumab plus FOLFIRI in participants with recurrent, unresectable, or metastatic RAS/BRAF wild-type colorectal cancer.Journal of Clinical Oncology. 2025;43(16_suppl):10.1200/jco.2025.43.16_suppl.tps3638

Sanderson E, Gibbs P, Tie J. The emerging clinical utility of ctDNA to guide adjuvant treatment in cancer. The Lancet Regional Health – Western Pacific. 2025;59:10.1016/j.lanwpc.2025.101595

Tie J, Wang Y, Loree JM, Cohen JD, Espinosa D, Wong R, Price TJ, Tebbutt NC, Lee M, Burge ME, Harris SJ, Lee B, Lynam JF, O’Callaghan CJ, Breadner DA, Bettegowda C, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. ctDNA-guided adjuvant chemotherapy escalation in stage III colon cancer: Primary analysis of the ctDNA-positive cohort from the randomized AGITG dynamic-III trial (intergroup study of AGITG and CCTG).Journal of Clinical Oncology. 2025;43(16_suppl):10.1200/jco.2025.43.16_suppl.3503

Tie J, Wang Y, Lo SN, Lahouel K, Cohen JD, Wong R, Shapiro JD, Harris SJ, Khattak A, Burge ME, Lee M, Harris M, McLachlan S-A, Horvath L, Karapetis C, Shannon J, Singh M, Yip D, Ananda S, Underhill C, Ptak J, Silliman N, Dobbyn L, Popoli M, Papadopoulos N, Tomasetti C, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: 5-year outcomes of the randomized DYNAMIC trial. Nature Medicine. 2025;31(5):10.1038/s41591-025-03579-w

Kim GY, Tie J, Gibbs P. Letter to the Editor: Are We Asking the Right Question for New Biomarkers – “Ready for Prime Time” Versus Demonstrated Clinical Utility?. Journal of the National Comprehensive Cancer Network. 2025;23(5):10.6004/jnccn.2025.7037

View all publications

Lab research projects

Blood biomarker studies

Registries

Professor Peter Gibbs started work in cancer registries with the colorectal cancer registry in 2009. Over time other disease registries have been developed to collect clinical information for a specific area of interest, and depending on the depth of clinical detail captured, can support a variety of research questions.

Longitudinal follow up within a registry, as well as potential data linkage to other routinely collected data software, eg electronic health records or National Death Index, allows for sound representation of real-world patients.

Real World Data collection in a number of cancers started at the Gibbs Lab in 2000, with colorectal cancer followed by breast, pancreas, gastro-oesophageal, brain, prostate, kidney, bladder, testicular, lung and melanoma.

Most recently head and neck cancers have been added to the collection of real world cancer data being undertaken in the Gibbs Lab.

CRC Accord/TRACC team: Professor Peter Gibbs, clinical support from Doctors Vanessa Wong, Hui-Li Wong, Iris Tung, Matthew Loft and Kate Dunne. project management and study coordination by team led by Michael Harold, Catherine McKay, Sharen Gibbs, Kelsey Serena and team of clinical data officers.

Breast cancer, Tabitha/ARORA HER2+, ER+ breast cancer team: Dr Sheau Wen Lok, clinical support from doctors, Vanessa Wong and Iris Tung. Project management support from Catherine Morton and team of clinical data officers.

Pancreas cancer, PURPLE pancreas cancer team: Dr Belinda Lee, clinical support from Doctor Richard To, Shehara Mendis, project management support from Nadia Ayres, Michael Harold and team of clinical data officers.

Gastro-oesophageal cancer, GATOR team: Dr Margaret Lee clinical support from Dr Grace Gard and project management support from Catherine McKay and team of clinical data officers.

Brain, BRAIN Brain cancer team: Clinical Lead Dr Lucy Gately, project management support from Megan Dumas and team of clinical data officer.

Genito-urinary cancers – prostate (Epad), kidney (KRAB), bladder (BLADDA), testicular (itestis) Clinical Lead Associate Professor Ben Tran with clinical support from Doctors Arsha Anton, Ciara Conduit, Elizabeth Liow and Andrisha-Jade Inderjeeth and project management support from Sophie O’Haire and Kristina Zlatic, Mary Moody and clinical data officers

Lung, INHALE led by Dr Ben Markman with clinical support from Doctor Sam Smith and project management support from Siobhan Gallus and team of clinical data officers.

Melanoma, MASTER lead by Dr Miles Andrews and project management support from Tina Cavicchiolo and team of clinical data officers.

Head and neck, ENHANCE lead by Professor Peter Gibbs with clinical support from Dr Shehara Mendis and project management support from Catherine McKay.

The Gibbs Lab has engaged with over 35 hospitals across Australia, New Zealand and Singapore. More recently we have been engaging with hospitals in South Korea to contribute to the real world data collection of cancer data across the multiple registries. These data registries hold comprehensive de-identified data on thousands of patients that can be shared with our collaborative partners to create large scalable datasets which provides valuable insights into the real-world patient landscape and changing patterns of care across Australia and internationally.

Registry Clinical Trials

Led by Professor Peter Gibbs and supported by Doctors Vanessa Wong, Lucy Gately, Associate Professor Ben Tran and Dr Steven David and project management team of Michael Harold, Catherine Morton, Megan Dumas, Roslynn Murphy, Siobhan Gallus, Kristina Zlatic and Sophie O’Haire.

Registry Clinical Trials combines conventional trial methodology with registry systems to produce real-world clinical evidence.

Registry based trials integrate the high internal validity (elimination of bias) of randomised clinical trials with the high external validity (applicable to a clinical setting) associated with enrolling real-world patients through a registry. These studies are addressing simple but important questions in the routine of common cancers, exploring issues not addressed in conventional clinical trials such as the optimal treatment sequence, combination or duration of available therapies.

Working with partners across the Victorian Comprehensive Cancer Centre (VCCC) alliance and private health services, the first Australian cancer-focused registry trials will investigate and evaluate promising new cancer treatment strategies for bowel cancer and brain tumours.

Registry trials are enabled by the comprehensive clinical data captured in clinical registries at many hospitals, including all VCCC partner hospitals, enabling researchers to compare the impact of different treatment strategies on large numbers of patients in a real-world setting.

Conventional cancer clinical trials typically have strict patient eligibility criteria, limiting patient access. For less common types of cancers, this can restrict researchers’ access to enough patients to draw statistically valid conclusions, high external validity through inclusion of real‐world patients and smaller centres. They can answer simple, pragmatic questions that are otherwise unlikely to ever be explored. There is rapid patient recruitment due to broad eligibility criteria.

Data collection is integrated into routine care and they substantially lower costs than conventional randomised clinical trials.

ALT-TRACC – investigating alternating two cycles of doublet chemotherapy versus standard continuous doublet chemotherapy as a new treatment strategy for newly diagnosed metastatic colorectal cancer

EX-TEM – examining the effectiveness of six months versus 12 months of post-radiation chemotherapy for glioblastoma, an aggressive form of brain cancer

REAL Pro – Registry-based study of Enzalutamide vs Abiraterone assessing cognitive function in elderly patients with metastatic castration-resistant prostate cancer.

AVATAR – Stereotactic Radiotherapy for Oligoprogressive ER-positive Breast Cancer

Email: registrytrials@mh.org.au
http://www.anzctr.org.au/

New trials are currently under development in brain, lung and colorectal cancer.

Reference and further reading
A comparison of conventional clinical trials and registry-based randomised controlled trials in multidisciplinary cancer care:

Foroughi S, Wong HL, Gately L, Lee M, Simons K, Tie J, Burgess AW, Gibbs P. Re-inventing the randomized controlled trial in medical oncology: The registry-based trial. Asia Pac J Clin Oncol. 2018 Jun 26. doi: 10.1111/ajco.12992.

Defining key design elements of registry-based randomised controlled trials: a scoping review

Karanatsios, B., Prang, KH., Verbunt, E, Yeung JM, Kelaher M & Gibbs P. Defining key design elements of registry-based randomised controlled trials: a scoping review. Trials 21, 552 (2020). https://doi.org/10.1186/s13063-020-04459-z

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