Immunotherapy is rapidly emerging as a promising cancer treatment. Unfortunately, endometrial cancer patients currently lack access to this innovative approach. In response to the rising cases of endometrial cancer globally, DOMENICA is addressing the need to explore immunotherapeutic options in the treatment of endometrial cancer, to improve outcomes for the thousands that are diagnosed with the disease every year.
Led by Principal Investigator Assoc Prof Alison Davis in Australia and New Zealand. this global initiative plans to open 130 sites worldwide, 61 of which are already active. The trial aims to enrol up to 15 patients in Australia and New Zealand (ANZ), with a total of 128 out of a planned 260 patients already randomised internationally.
The trial is led by ANZGOG in Australia and New Zealand with ARCAGY-GINECO serving as the international sponsor.
DOMENICA’S PRINCIPAL INVESTIGATOR
Assoc Prof Alison Davis, Medical Oncologist (ACT)
“DOMENICA is asking an important question about the relative activity of immunotherapy compared to chemotherapy and includes assessment of patient reported toxicities and QOL. As chemotherapy has some significant short and long term toxicities, and as this patient group is often older with co-morbidities, finding a well tolerated and active treatment that is less toxic than chemotherapy would be a major advance for our patients.”
Why is DOMENICA needed?
Over the past two decades, incidence rates of endometrial cancer have nearly doubled in Australia and nearly tripled in New Zealand, emphasising the urgency for more research, more funding, and more awareness of the symptoms and risk factors.
Endometrial cancer is the most common type of gynaecological cancer and represents 90-95% of uterine cancer cases.
This trial addresses a critical gap in current medical research for endometrial cancer. There are currently no ongoing trials that can will answer of the question of efficacy of Immune agent alone versus chemotherapy in the group of Mismatch Repair Deficiency (MMRd)/Microsatellite instability-high (MSI-H) endometrial cancer patients in first line setting for advanced/metastatic disease.
What is DOMENICA investigating?
DOMENICA, a Phase III, randomised, open-label, multi-centre study, is a unique opportunity to evaluate Dostarlimab in monotherapy in first line setting for advanced endometrial cancer and to demonstrate in a randomised phase III trial the benefit of Dostarlimab in advanced endometrial MMR deficient cancer versus the standard of care (Paclitaxel and Carboplatin). The goal of the trial is to determine if immune agent treatment alone could be the new standard of care instead of chemotherapy for MMR deficient patients. The primary endpoint of the study is progression free survival, with overall survival as a key secondary endpoint.
Eligibility criteria
Eligibility for the trial is specific to women with MMR deficient advanced or recurrent endometrial cancer, ensuring that the study targets the patient group most likely to benefit from the investigational treatment.
It is advisable that patients discuss their concerns and the best course of action regarding their participation in clinical trials with their oncologist.
Where will DOMENICA be available?
| State/Country | Site Name | Principal Investigator |
| ACT | Canberra Hospital | A/ProfAlison Davis |
| NSW | Calvary Mater Newcastle | Dr Janine Lombard |
| NZ | Auckland Hospital | Dr Michelle Wilson |
Patient referrals to DOMENICA
We encourage referrals to this study via medical professionals. Please contact the Clinical Trial Project Manager at domenica@anzgog.org.au for more information.
For more information on the participation criteria please visit here:
