Oncology and haematology clinical trials

Breast: MK3475 KEYNOTE-756

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination with Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer

This study is currently recruiting participants.

Primary Objective: The purpose of this randomized, double-blind, phase III study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.

Principal Investigator: Sarah Barton

Research Coordinator: Judy Murray

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03725059

Breast: PantoCIN

Pantoprazole Prophylaxis Against Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) for Patients Receiving Breast Cancer Chemotherapy

This study is currently recruiting participants.

Primary Objective: This phase II, randomised double-blind, placebo controlled, crossover study explores whether a commonly used medication called Pantoprazole can help prevent delayed nausea and vomiting from chemotherapy for early breast cancer. Delayed nausea, and occasionally vomiting, can occur after breast cancer chemotherapy, affecting quality of life. A potential cause of these delayed side effects is that the chemotherapy may cause stomach irritation. Pantoprazole is commonly used to treat stomach irritation by reducing stomach acid, which may in turn improve nausea and/or vomiting.

Principal Investigator: Sarah Barton

Research Coordinators: Judy Murray, Maureen Blakemore

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03948477

Lung: CHECKPOINT-101

Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors

This study is currently recruiting participants.

Primary Objective: CK-101 is a novel, potent, small molecule tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral CK-101; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral CK-101; to assess the safety and efficacy of CK-101 in previously treated NSCLC patients known to have the T790M EGFR mutation.

Principal Investigator: Brendan Luey

Research Coordinators: Judy Murray, Rosie Whitmore

Trial Website: https://clinicaltrials.gov/ct2/show/NCT02926768

Melanoma: MK3475 KEYNOTE-587

Long-term Safety and Efficacy Extension Study for Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab

This study is currently recruiting participants.

Primary Objective: A Multicenter, Open label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial

Principal Investigator: Catherine Barrow

Research Coordinator: Susan Millmow

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03486873

Pancreas: PURPLE Registry

Understanding Routine Practice and Lifting End results (PURPLE): A Prospective Pancreatic Cancer clinical registry

Primary Objective: This project is non-interventional registry of the treatment and outcomes of patients with pancreatic cancer. This registry will capture data on presentation and the disease course of pancreatic cancer, surgical interventions for primary and metastatic disease, prescription of systemic therapies, and information regarding multi-disciplinary management and outcomes of this disease in the routine clinical practice setting.

This registry is currently enrolling participants.

Principal Investigator: Kate Clark

Research Coordinator: Tali Cocker

Registry Website: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617001474347

Renal: Phase I/II BMS Subcut Nivo Study

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

This study is currently recruiting participants.

Primary Objective: The purpose of this phase I/II pharmacokinetic multi-tumor study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20.

Principal Investigator: Anne O'Donnell

Research Coordinators: Rachael Cahir, Rosie Whitmore, Maureen Blakemore

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03656718

Urothelial: Phase I BGB-A317 &290

The Safety, Pharmacokinetics and Antitumor Activity of BGB-A317 in Combination with BGB-290 in Subjects With Advanced Solid Tumors

This study is currently on hold.

Primary Objective: The purpose of this phase 1/1b, open label, multiple dose, dose escalation and expansion study is to investigate is to assess the safety, pharmacokinetics and antitumor activity of the anti-PD-1 monoclonal antibody BGB-A317 in combination with the PARP Inhibitor BGB-290 in subjects with advanced solid tumors.

Principal Investigator: Anne O'Donnell

Research Coordinators: Rachael Cahir, Maureen Blakemore

Trial Website: https://clinicaltrials.gov/ct2/show/NCT02660034

Breast: EXPERT ANZBCTG

EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer

This study is currently recruiting participants.

Primary Objective: This is a randomised, phase III, non-inferiority trial evaluating radiation therapy versus observation following breast conserving surgery and planned endocrine therapy in patients with stage I breast cancer of luminal A subtype defined using the Prosigna (PAM50) Assay.

Principal Investigator: Anna Nicholson

Research Coordinators: Judy Murray, Debra Morriss

Trial Website: https://clinicaltrials.gov/ct2/show/NCT02889874

AML: MORPHOS Astellas 2215-CL-0304 AML

A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)

This study is currently recruiting participants.

Primary Objective: The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.

Principal Investigator: Travis Perera

Research Coordinator: Maureen Blakemore

Trial Website: https://clinicaltrials.gov/ct2/show/NCT02997202

CLL: ALPINE

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia

This study is currently recruiting participants.

Primary Objective: This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in approximately 400 patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Principle Investigator: Robert Weinkove

Research Coordinator: Debra Morriss

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03734016

CML: KISS

Kinase Inhibition with Sprycel Start up

This study is currently recruiting participants.

Primary Objective: This phase II study will investigate the efficacy and safety of a treatment plan for patients with newly diagnosed CML-CP, where dasatinib will be used to more rapidly induce a molecular response (MR3.0) within 12 months, after which imatinib will be used to maintain the CML in that remission. It is hypothesised that imatinib is safe and effective in maintaining MR3.0 in patients with CML who achieve MR3.0 at 12 months following initial induction therapy with dasatinib.

Principal Investigator: Travis Perera

Research Coordinator: Anjela Stewart

Trial Website: https://clinicaltrials.gov/ct2/show/NCT03193281

Myeloma: MRDR Registry

Myeloma & Related Diseases Registry (Monash University)

This registry is currently enrolling participants.

Primary Objective: The Myeloma and Related Diseases Registry (MRDR) is a register of patients diagnosed with multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), plasma cell leukaemia or plasmacytoma. The MRDR collects data on patterns of treatment and variation in patient outcomes (both survival and quality of life). Ultimately, it will help clinicians and hospitals to provide the best possible care to people with these conditions and allow evaluation of the translation of advances in therapy (such as the introduction of new targeted therapies) into long-term outcomes, outside the setting of clinical trials.

Principal Investigator: Anup George

Research Coordinator: Anup George, Kelly Harrison, CTU

Registry Website: https://mrdr.net.au/