Oncology clinical trials at Bunbury

RELATIVITY-1093

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent NSQ NSCLC With PD-L1 1-49%

https://clinicaltrials.gov/study/NCT06561386

PI: A/Prof Kynan Feeney

Sponsor:  Bristol-Myers Squibb

AndroMETa (M25-287, AbbVie)

A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

https://clinicaltrials.gov/study/NCT07005102?term=m25-287&rank=1

PI: Dr Raj Tota

Sponsor:  AbbVie

RAINFOL-05

A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants with Non-Small Cell Lung Cancer

https://clinicaltrials.gov/study/NCT07288177

PI: A/Prof Kynan Feeney

Sponsor:  Genmab

CA052-1000

A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as First-line Treatment for Participants with Locally Advanced or Metastatic, Non-Small Cell Lung Cancer(NSCLC).

PI: A/Prof Kynan Feeney

Sponsor:  Bristol-Myers Squibb

MountainTAP-30

A Study Comparing BMS-986504 in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion.

https://clinicaltrials.gov/study/NCT07076121?term=ca240-0030&rank=1

PI: Dr Kynan Feeney

Sponsor:  Bristol-Myers Squibb

ROSETTA Gastric-204

A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma.

https://clinicaltrials.gov/study/NCT07221149?term=rosetta%20gastric&viewType=Card&rank=1

PI: Dr Kynan Feeney

Sponsor:   Bristol-Myers Squibb

FIERCE-HN

A Multicenter, Randomized, Double Blind, Placebo - Controlled, Phase 3 Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV -Negative Head and Neck Squamous Cell Carcinoma

https://clinicaltrials.gov/study/NCT06064877

PI: Dr Raj Tota

AVEO Pharmaceuticals, Inc

OrigAMI-5

A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition toCarboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

https://clinicaltrials.gov/study/NCT07276399

PI: Dr Raj Tota

Sponsor:  Janssen Cilag

ROSETTA CRC-203

A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer.

https://clinicaltrials.gov/study/NCT07221357?term=rosetta%20crc&rank=1

PI: Dr Kynan Feeney

Sponsor:  Bristol-Myers Squibb

GCT115-08

A Randomized, Open-label, Phase 3 Trial of Petosemtamab in Combination With mFOLFOX6 or FOLFIRI Versus Cetuximab in Combination With mFOLFOX6 or FOLFIRI as First-line Treatment for Participants With RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer.

PI: Dr Kynan Feeney

Sponsor: Genmab

• Cancer is the leading cause of death in Australia, about 1 in 2 Australian men and 1 in 3 Australia women will be diagnosed with cancer by the age of 85.
• Clinical trials play an essential role in discovering new and more effective treatments for cancer.
• Great strides are being made in understanding cancer and we are working every day to achieving better quality and quantity of life for patients.

• Providing exceptional care to patients by offering innovative cancer treatment which may only be available in a clinical trial setting
• Conducting clinical trials for patients having treatment for a range of cancer types including lung, breast, colorectal and upper gastrointestinal cancer
• Continual improvement of clinical trial processes and alignment with contemporary best practice
• Investigator-led research with a focus on enhanced comprehensive care for patients having cancer treatment

• Associate Professor Kynan Feeney - Medical Oncologist
• Associate Professor Daphne Tsoi - Medical Oncologist
• Dr Sanjay Mukhedkar - Medical Oncologist
• Dr Raj Tota – Medical Oncologist
• Dr Tim Slattery - Medical Oncologist
• Dr Adeolu Freeman - Medical Oncologist
• Rebecca Weselman – Clinical Trials Regulatory & Quality Officer
• Sabina Jelinek - Clinical Trials Nurse
• Tijana Coe – Senior Clinical Trial Co-ordinator
• Diane DeVilla – Senior Clinical Trial Co-ordinator
• Uzoamaka Samuel-Oparah - Clinical Trial Co-ordinator
• Mel Hernandez - Clinical Trial Co-ordinator
• Tina Kern – Clinical Trials Support Officer
• Sean Tee - Clinical Trials Pharmacist

• Janjigian Y, Shitara K, Ajani JA, Shen L, Garrido M, Gallardo C, Wyrwicz L, Feeney K et al. (2026) Nivolumab plus chemotherapy as first-line treatment for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: 5-year follow-up results from CheckMate 649. Annal of Oncology. 37: 787-797. DOI: 10.1016/j.annonc.2026.02.003
• Babiker HM, Picozzi V, Chandana SR, Melichar B, Kasi A, Gang J, Gallego J, Bullock A, Chunyi H, Wyrwicz L, Hitre E, Osipov A, de la Fouchardiere C, Ales I, Dragovich T, Lee W, Feeney K, et al. (2025) Tumor Treating Fields With Gemcitabine and Nab Paclitaxel  for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study. Journal of Clinical Oncology. 43:2350-2360. DOI: 10.1200/JCO-25-00746
• Yap N, Wong V, Morton C, de Boer R, Baron-Hay S, Tsoi D, et al. (2024) Medicine Access Programmes: what do patients think – a patient‐reported outcome study on ribociclib in metastatic breast cancer in Australia. Internal Medicine Journal 54 DOI: 10.1111/imj.16536
• Hegewisch-Becker S, Mendez G, Chao J, Nemecek R, Feeney K et al. (2024) First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study. Journal of Clinical Oncology 42 DOI: 10.1200/JCO.23.01636
• Cho BC, Lu S, Felip E, Spira AI, Girard N, Mukhedkar S et al (2024) Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC. New England Journal of Medicine 391:1486-1498. DOI:10.1056/NEJMoa2403614
• Janjigian YY, Ajani JA, Moehler M, Shen L, Garrido M, Gallardo C, Feeney K et al (2024) First-line Nivolumab Plus chemotherapy for advanced Gastric, Gastroesophageal Junction, and esophageal adenocarcinoma: 3-year follow-up of the phase III CheckMate 649 trial. Journal of Clinical Oncology 42 DOI: 10.1200/JCO.23.01601
• Shitara K, Ajani JA, Moehler M, Garrido M, Gallardo C, Shen L, Yamaguchi K, Wyrwicz L, Skoczylas T, Bragagnoli AC, Liu T, Tehfe M, Elimova E, Bruges R, Zander T, de Azevedo S, Kowalyszyn R, Pazo-Cid R, Schenker M, Cleary JM, Yanez P, Feeney K, et al. (2022) Nivolumab plus chemotherapy or ipilimumab in gastro-oesophageal cancer. Nature. Mar 23. DOI: 10.1038/s41586-022-04508-4.
• Paz-Ares LG, Ciuleanu TE, Cobo-Dols M, Bennouna J, Cheng Y, Mizutani H, Lingua A, Reyes F, Reinmuth N, De Menezes JJ, Jassem J, Protsenko S, Feeney K, et al. (2022) First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) + 2 cycles of chemotherapy (chemo) versus chemo alone (4 cycles) in patients (pts) with metastatic non–small cell lung cancer (NSCLC): 3-year update from CheckMate 9LA. Journal of Clinical Oncology 40 Suppl 17. DOI:10.1200/JCO.2022.40.17_suppl.LBA9026.
• Chan A, Lomma C, Chih H, Blackely E, Woodward N, Tsoi D, et al. (2021) Incorporation of eribulin in the systemic treatment of metastatic breast cancer patients in Australia. Asia-Pacific Journal of Clinical Oncology 18: 201-208. DOI: 10.1111/ajco.13576
• Wong V, de Boer R, Baron-Hay S, Blum R, Boyle F, Chua S, Clarke K, Cuff K, Green M, Lim E, Mok K, Nott L, Nottage M, Tafreshi A, Tsoi D, et al (2022) Real-world outcomes of Ribociclib and Aromatase inhibitor use in first line hormone receptor positive , HER2-negative metastatic breast cancer. Clinical Breast Cancer 22, 792-800. DOI: 10.1016/j.clbc.2022.08.011
• Paz-Ares LG, Ramalingam SS, Ciuleanu TE, Lee JS, Urban L, Caro RB, Park K, Sakai H, Ohe Y, Nishio M, Audigier-Valette C, Burgers JA, Pluzanski A, Sangha R, Gallardo C, Takeda M, Linardou H, Lupinacci L, Lee KH, Caserta C, Provencio M, Carcereny E, Otterson GA, Schenker M, Zurawski B, Alexandru A, Vergnenegre A, Raimbourg J, Feeney K, et al. (2022) First-line Nivolumab plus Ipilimumab in advanced NSCLC: 4-year outcomes from the randomized, open-label, Phase 3 CheckMate 227 Part 1 trial. Journal of Thoracic Oncology 17, 289-308. DOI: 10.1016/j.jtho.2021.09.010.
• Nowak AK, Newton RU, Cruickshank T, Cormie P, Halkett GK, Tsoi D, Galvao DA. (2023) A feasibility, safety, and efficacy evaluation of supervised aerobic and resistance exercise for patients with glioblastoma undertaking adjuvant chemoradiotherapy. Neuro-Oncology Practice 10 (Suppl. 3). DOI: 10.1093/nop/npad006
• Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Wyrwicz L, Yamaguchi K, Skoczylas T, Bragagnoli AC, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, et al. (2023) A plain language summary of the CheckMate 649 study: nivolumab in combination with chemotherapy compared to chemotherapy alone for untreated advanced or metastatic cancer of the stomach or esophagus. Future Oncology 19: 739-752. DOI: 10.2217/fon-2022-1149.
• Tripathy D, Tolaney SM Seidman AD et al (2022) Treatment with Etirinotecan Pegol for patients with metastatic breast cancer and brain metastases. JAMA Oncology 8: 1047-1052. DOI:10.1001/jamaoncol.2022.0514 (A/Prof D Tsoi contributing investigator)