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.

 

DUO-E

Registered Title   A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)
 Purpose  A study to assess the efficacy and safety of durvalumab in combination with platinum-based
chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without
olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.
Lay Summary  N/A
WA Trial Sites   Oncology  Ph. (08) 6465 9204
 Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

SORAYA

Registered Title   SORAYA: A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression
 Purpose  This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in patients with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. All patients will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight administered on Day 1 of every 3-week cycle.
Lay Summary  N/A
WA Trial Sites   Oncology  Ph. (08) 6465 9204
Links US National Library of Medicine 

Acknowledgements: US National Library of Medicine

 

KEYNOTE-A18 / ENGOT-cx11

Registered Title A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18 / ENGOT-cx11)
Purpose The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.

The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival.

Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.

Lay Summary  N/A
WA Trial Sites  
Links  US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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

 

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

 

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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