Gynaecological

he following list provides a brief description of gynaecological 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.

 

ZN-c3-002

Registered Title  A Phase 1b Study of ZN-c3 in Combination With Chemotherapy in Patients With Platinum-Resistant Ovarian, Peritoneal or Fallopian Tube Cancer
Purpose  This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3 in combination with other drugs.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
Links US National Library of Medicine 
Acknowledgements: US National Library of Medicine

 

PRECISE

Registered Title A Phase II, Signal-Seeking Trial of the Clinical Benefit Rate Associated With Pamiparib in Subjects With Germline or Somatic BRCA1/2 High Grade Serous Ovarian Cancer or Carcinosarcoma Who Have Progressed on P-gp Substrate Chemotherapy or PARPi With the Presence of an ABCB1 Fusion and the Absence of a BRCA1/2 Reversion
Purpose This study is a phase II, multi-centre, open label study in patients with advanced ovarian cancer. The treatment being tested is Pamiparib, with daily dosing.

All patients enrolled to the study will receive treatment with pamiparib. Patients will be selected for entry into the study based on the molecular signature of their cancer.

Lay Summary  N/A
WA Trial SItes  SCGH Medical Oncology Ph. (08) 6383 3000
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

AK104-201-AU

Registered Title A Phase 2, Multicenter, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of AK104 in Subjects With Recurrent or Metastatic Cervical Cancer
Purpose  This is a Phase 2, global, multicenter, open label, single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 monotherapy in adult subjects with previously treated recurrent or metastatic cervical carcinoma.
Lay Summary  N/A
WA Trial Sites  SCGH Medical Oncology Ph. (08) 6383 3000
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

IGNITE

Registered Title A Phase II signal-seeking trial of Adavosertib (AZD1775) targeting recurrent high grade serous ovarian cancer (HGSC) with Cyclin E1 (CCNE1) over-expression with and without gene amplification to determine the clinical benefit rate.
 
Purpose This study will determine if the use of adavosertib as monotherapy provides clinical benefit to patients with high grade serous ovarian cancer
Lay Summary  N/A
WA Trial Sites  SCGH Medical Oncology Ph. (08) 6383 3000
Links  Australian and New Zealand Clinical Trials Registry

Acknowledgements: Australian and New Zealand Clinical Trials Registry

 

MS200647_0017

Registered Title A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With Advanced, Unresectable Cervical Cancer With Disease Progression During or After Platinum-Containing Chemotherapy
Purpose The main purpose of this study is to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research ph. 08 6382 5513
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

MK7902-001 / LEAP-001

Registered Title A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)
Purpose The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS).
Lay Summary  N/A
WA Trial Sites   (Radiation Oncology) Ph. 08) 6383 3204
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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.
Lay Summary  N/A
WA Trial Sites  Linear Clinical Research Ph. 08 6382 5513
Sites  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

BGB-900-103

Registered Title A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
 
 Purpose This is an open-label, multicenter, non-randomized Phase 1b clinical trial for patients with histologically or cytologically confirmed locally advanced or metastatic tumors including non-squamous or squamous NSCLC, RCC, OC, or melanoma.
 Lay Summary  N/A
WA Trial Sites  Linear Clinical Research Ph.08 6382 5513
 Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

EMBRACE

Registered Title

Phase II clinical trial of the PARP inhibitor, olaparib, in HR-deficient metastatic breast and relapsed ovarian cancer in patients without germline mutations in BRCA1 and BRCA2: The EMBRACE study

Purpose

This study is testing olaparib, in Homologous recombination (HR) deficient metastatic breast and relapsed ovarian cancer in patients who do not have hereditary mutations in BReast CAncer susceptibility gene 1 and gene 2 (BRCA1 and BRCA2).

Lay Summary

 N/A

WA Trial Sites

 Cancer Centre Clinical Trials Unit  Ph.  08 615 26530

Links

 Australian and New Zealand Clinical Trials Registry

Acknowledgements: Australian and New Zealand Clinical Trials Registry

 

LACC Cervical Cancer Study

Registered Title

A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy Versus Abdominal Radical Hysterectomy in Patients With Early Stage Cervical Cancer.

Purpose

The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology.

Lay Summary

N/A

WA Trial Sites

  Ph. (08) 6465 9204

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

iPRIME

Registered Title
 A Phase II Study of Durvalumab and Tremelimumab in combination with Neoadjuvant Carboplatin and Paclitaxel in newly diagnosed women with advanced high grade Serous Ovarian, Fallopian Tube and Peritoneal Cancers “iPRIME”.
 Purpose The purpose of this research project is to test how safe and effective the combination treatment of durvalumab and tremelimumab in combination with standard chemotherapy is as a treatment for patients with ovarian, fallopian tube or peritoneal cancers.
 Lay Summary

Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive [18 weeks/6 cycles] of treatment with Carboplatin, paclitaxel combined with durvalumab and tremelimumab (Du-T-NACT) administered intravenously (i.e. directly into the vein). This will then be followed by maintenance therapy with Durvalumab (every 4 weeks) and Tremelimumab (every 12 weeks) for 36 weeks or until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. Durvalumab and tremelimumab are new drugs which are designed to increase the body's immune response. Participants in the other group will receive [18 weeks/6 cycles] of chemotherapy with Carboplatin and paclitaxel only, followed by an observation period, which involves 4 weekly CA-125 assessments. Participants in both groups may also undergo interval debulking surgery after 3 cycles of treatment, if suitable.

 WA Trial Sites

Linear Clinical Research  Ph. 08 6382 5513

 Links  Australian and New Zealand Clinical Trials Registry

Acknowledgements: Australian and New Zealand Clinical Trials Registry

 

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