A Multicentre Phase II Trial of Durvalumab Versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinomas
- Conditions
- Ovarian Clear Cell Carcinoma
- Interventions
- Drug: standard chemotherapy
- Registration Number
- NCT03405454
- Lead Sponsor
- National University Hospital, Singapore
- Brief Summary
The purpose of this study is to find out if treatment with a study drug, durvalumab has beneficial effects in people who have recurrent ovarian clear cell cancer and to determine what effects (both good and bad) it has on them and their cancer.
- Detailed Description
The purpose of this study is to find out if treatment with a study drug, durvalumab has beneficial effects in patients who have recurrent ovarian clear cell cancer and to determine what effects (both good and bad) it has on them and their cancer.
In the recurrent ovarian clear cell cancer (OCCC) setting, responses to further lines of chemotherapy are uniformly low. Given the limited benefit observed from chemotherapy treatments, there is now great interest in the development of molecular targeted therapy for the treatment of OCCC, including immunotherapy.
Researchers have found that sometimes the body's own immune system may be able to slow down or control cancer growth. Sometimes though, this natural immune system response stops, and the cancer cells are not killed by the immune system. Research has shown that in some patients, proteins on the surface of cancer cells and immune cells bind together and send signals that stop the immune cells from killing the cancer cells. One such protein is called Programmed Cell Death Ligand 1 or PD-L1 for short. New drugs like durvalumab work to block this signal and to increase the immune response against cancer cells. Durvalumab is an antibody to PDL1 (a protein that binds to PD1 and blocks the anti tumour activity of immune cells), and it is hoped that by blocking the interaction between PDL1 and PD1, the immune cells will once again be able to attack the cancer cells and thus prevent or slow down cancer growth.
This will be the first study to evaluate the efficacy of durvalumab in patients with recurrent ovarian clear cell carcinomas.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard chemotherapy standard chemotherapy Patients on physician's choice of chemotherapy are allowed to receive any systemic chemotherapy either as a single agent or in combination. However, biologics( including bevacizumab) and oral tyrosine kinase inhibitors will not be allowed for patients on this arm durvalumab durvalumab Patients on durvalumab will be given at 1500mg fixed dose every 4 weeks for 24 months
- Primary Outcome Measures
Name Time Method Progression free survival 4 years Progression free survival (PFS) is defined as the time from the first day of treatment to the first observation of radiological or clinical disease progression or death due to any cause or last follow-up. The progression will be defined by RECIST criteria v1.1 for patients on the chemotherapy arm which includes first instance of more than 20% increase in the sum of diameters or unequivocal progression in non-target disease. The sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) is calculated at baseline and at each tumor assessment.
- Secondary Outcome Measures
Name Time Method Health related Quality of life (HRQOL) 4 years HRQOL will be measured using European Organization for Research and Treatment of Cancer Core questionnaire.
Objective Response Rate 4 years Objective response rate (ORR) is defined as the percentage of subjects with a confirmed CR or PR as per RECIST 1.1 criteria. Response will be evaluated every 8 weeks while on treatment.
Overall survival 4 years Overall survival (OS) is measured as time from the first day of treatment to the time of death from any cause.
Adverse event profile 4 years Adverse event profile of durvalumab in this patient population as measured by CTCAE 4.0 criteria
Trial Locations
- Locations (2)
National University Hospital
🇸🇬Singapore, Singapore
National Cancer Centre
🇸🇬Singapore, Singapore