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 |
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
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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). |
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Lay Summary |
N/A |
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WA Trial Sites |
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Links |
Cancer Centre Clinical Trials Unit Ph. 08 615 26530Acknowledgements: 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 “iPRIMEâ€. |
| 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 |
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| Links | Australian and New Zealand Clinical Trials Registry |
Acknowledgements: Australian and New Zealand Clinical Trials Registry
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