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Upper Gastrointestinal, Pancreatic & Liver

The following list provides a brief description of upper gastrointestinal, pancreatic and liver 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.

CA224-020

Registered Title	A Phase I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Purpose	The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
Lay Summary	N/A
WA Trial Sites	Ph. 08 6382 5513
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

SKYSCRAPER-07

Scientific Title	This is a Phase III, randomized, double-blind, three-arm, global, multicenter, placebo-controlled study designed to evaluate the safety and efficacy of tiragolumab in combination with atezolizumab compared with placebo in patients with unresectable locally advanced esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and who have completed definitive concurrent chemoradiation therapy.
Purpose	N/A
Lay Summary	N/a
WA Trial Sites	Ph. (08) 6465 9204
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

ORIENT-15

Registered Title	A Multicenter, Double-Blind, Randomized Phase 3 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination With Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)
Purpose	This is a randomized, double-blind multi-center, phase III study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.
Lay Summary	N/A
WA Trial Sites	Ph. (08) 6383 3000 Ph. (08) 6465 9204
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

LEAP-012

Registered Title	A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)
Purpose	The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).
Lay Summary	N/A
WA Trial Sites	Ph. 08 92248055
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

PROOF

Registered Title	A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial
Purpose	Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions/translocations. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.
Lay Summary	N/A
WA Trial Sites	Ph. (08) 6465 9204
Summary	US National Library of Medicine

Acknowledgements: US National Library of Medicine

APOLLO

Registered Title	A Phase 1/2 Dose Escalation and Expansion Study of Combination APL-501 or Nivolumab With APL-101 in Locally Advanced or Metastatic Hepatocellular and Renal Cell Carcinoma
Purpose	This is an open-label Phase 1/2 study to assess the safety and tolerability of combination PD-1 inhibitor (APL-501 or nivolumab) administered concomitantly with c-Met inhibitor (APL-101), to determine the recommended Phase 2 dose of the combination, and to obtain preliminary efficacy in HCC or RCC subjects with advanced or metastatic disease that have not been previously treated with a PD 1 inhibitor or a c-Met inhibitor. HCC subjects will receive the combination APL-501 plus APL-101 while RCC subjects will receive the combination nivolumab plus APL-101.
Lay Summary	N/A
WA Trial Sites	Ph. (08) 9242 7640 Ph. 08 615 26530
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

NAPOLI 3

Registered Title	An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas
Purpose	The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
Lay Summary	N/A
WA Trial Sites	Cancer Centre Clinical Trials Unit Ph. (08) 615 26530 St John of God Subiaco Ph. (08) 6465 9204
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

NuTide:121

Registered Title	A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer
Purpose	NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer.
Lay Summary	N/A
WA Trial Sites	Phone 08 615 26530 Phone (08) 6383 3000
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

IMbrave050

Registered Title		A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
Purpose		This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.
Lay Summary		N/A
WA Trial Sites		Cancer Centre Clinical Trials Unit ph. (08) 615 26530
Links		US National Library of Medicine

Acknowledgements: US National Library of Medicine

KEYNOTE-937

Registered Title	A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (KEYNOTE-937)
Purpose	This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).
Lay Summary	N/A
WA Trial Sites	ph. (08) 92248055
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

COSMIC-312

Registered Title	A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy
Purpose	This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.
Lay Summary	N/A
WA Trial Sites	Medical Oncology Ph. 08 6383 3000. Radiation Oncology Ph. 08 6383 3204
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

DYNAMIC-Pancreas

Registered Title	Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Early Stage Pancreatic Cancer: A Multicentre Randomised Study (DYNAMIC- Pancreas)
Purpose	Pancreatic cancer cells have DNA mutations that are not present in normal cells. For some people, cancer-specific DNA can be found circulating in their bloodstream after they had surgery to remove their pancreatic cancer. This tumour-specific DNA may be evidence that some cancer cells have escaped before the pancreatic cancer was removed. The DYNAMIC-Pancreas study aims to see whether a test called "circulating tumour DNA" can be used to decide the type and duration of post-surgery chemotherapy.
Lay Summary	N/A
WA Trial Sites	Cancer Centre Clinical Trials Unit Ph. (08) 615 26530
Links	Australian New Zealand Clinical Trials Registry

Acknowledgement: Australian New Zealand Clinical Trials Registry

COMPETE

Registered Title	A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)
Purpose	The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
Lay Summary	Lay Summary
WA Trial Sites	Cancer Centre Clinical Trials Unit Ph. (08) 615 26530
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

EMERALD - 2

Registered Title	A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Purpose	A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.
Lay Summary	N/A
WA Trial Sites	ph. (08) 6151 1061
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

ACTICCA-1 Gallbladder Carcinoma Study

Registered Title	Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Observation After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma (ACTICCA-1 Trial)
Purpose	This is a multicentre, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. observation alone in patients after curative intent resection of cholangiocarcinoma and muscle invasive gall bladder carcinoma.
Lay Summary	N/A
WA Trial Sites	Medical Oncology Ph. (08) 6383 3000
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

INTEGRATE II Gastro-Oesophageal Cancer Study

Registered Title	A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC).
Purpose	Advanced Gastro-oesophageal Carcinoma (AGOC) has a poor prognosis, and there is no established standard treatment following failure of first and second line chemotherapy. Regorafenib (BAY 73-4506) is an investigational oral multi-targeted tyrosine kinase inhibitor (TKI) which targets angiogenic (VEGF, TIE-2), stromal (PDGF-β), and oncogenic (RAF, RET and KIT) receptor tyrosine kinases, and has shown activity in other solid tumours. Regorafenib was shown to prolong PFS across all regions/subgroups in INTEGRATE I The general aim of this study is to determine if regorafenib improves overall survival in refractory AGOC.
Lay Summary	N/A
WA Trial Sites	St John of God Ph. (08) 6465 9204 Medical Oncology Ph. (08) 6383 3000
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

NABNEC AG0215NET

Registered Title	A Feasibility Study Of NAB-Paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas
Purpose	Gastrointestinal Neuroendocrine Tumours (NETs) are gaining increasing recognition as a highly prevalent disease, responsive to a number of therapies, some of which are proven in modern randomised controlled trials, but many of which still require high quality clinical trial evidence to confirm their effectiveness and guide their use in practice. This study is the first prospective trial to evaluate modern combination chemotherapy. for comp.
Lay Summary	N/A
Wa Trial Sites	Cancer Centre Clinical Trials Unit Ph. (08) 615 26530
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

TOPGEAR (TROG 08.08)

Registered Title	A randomised phase II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer.
Purpose	The primary objective is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving pathological complete response (pCR) rates in the first instance, and subsequently overall survival, in patients undergoing adequate surgery (D1 dissection) for resectable gastric cancer.
Lay Summary	The optimal management of patients with resectable gastric cancer continues to evolve. Chemotherapy regimes are better, radiation techniques have improved and there is an increasing interest in the use of chemoradiotherapy prior to surgery for gastric cancer. The important question addressed in this trial is whether chemoradiation is better than chemotherapy alone in the treatment of resectable gastric cancer.
WA Trial Sites	Medical Oncology Ph. (08) 6383 3000
Links	Trans-Tasman Radiation Oncology Group Australian New Zealand Clinical Trials Registry

CEND1

Registered Title	A Phase 1 Clinical Trial of CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Exocrine Pancreatic Cancer
Purpose	This is an open-label, multicenter, dose-escalation, safety, pharmacodynamic, pharmacokinetic study of CEND-1 in combination with nabpaclitaxel and gemcitabine administered weekly for three weeks followed by one week off over 28 days. This protocol is designed to evaluate the safety, tolerability, and biologic activity of CEND-1 in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who are undergoing combination therapy with nabpaclitaxel and gemcitabine. CEND-1 is a tumor-penetrating peptide (scientifically also known as iRGD) that activates a drug transport mechanism specifically in tumors. Study involves an initial dose escalation phase with three different CEND-1 dose levels, first as a monotherapy (during 1-week run-in), followed by combination therapy with nabpaclitaxel and gemcitabine (one 28-day treatment cycle). A subsequent expansion phase with approximately 28 subjects will assess the safety, tolerability and preliminary efficacy of the combination treatment using two different CEND-1 dose levels.
Lay Summary	N/A
WA Trial Sites	ph. (08) 6465 9204
Links	US National Library of Medicine

Acknowledgements: US National Library of Medicine

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