A Multicentre Phase II Trial of Durvalumab Versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinomas
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|ClinicalTrials.gov Identifier: NCT03405454|
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Clear Cell Carcinoma||Drug: durvalumab Drug: standard chemotherapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized 2:1 to receive either durvalumab at a dose of 1500mg every four weeks for a maximum of 24 months or physician's choice of chemotherapy|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre Phase II Randomised Trial of Durvalumab (MEDI4736) Versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinomas (MOCCA)|
|Actual Study Start Date :||October 9, 2017|
|Estimated Primary Completion Date :||September 15, 2021|
|Estimated Study Completion Date :||March 15, 2022|
Active Comparator: 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
Drug: standard chemotherapy
chemotherapy treatment will be administered as per local institutional guidelines
Patients on durvalumab will be given at 1500mg fixed dose every 4 weeks for 24 months
Durvalumab will be given at 1500mg fixed dose every 4 weeks for 24 months or until the appearance of significant treatment-related toxicity or disease progression
- Progression free survival [ Time Frame: 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.
- Objective Response Rate [ Time Frame: 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 [ Time Frame: 4 years ]Overall survival (OS) is measured as time from the first day of treatment to the time of death from any cause.
- Health related Quality of life (HRQOL) [ Time Frame: 4 years ]HRQOL will be measured using European Organization for Research and Treatment of Cancer Core questionnaire.
- Adverse event profile [ Time Frame: 4 years ]Adverse event profile of durvalumab in this patient population as measured by CTCAE 4.0 criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405454
|Contact: David SP Tan||(65) 6779 email@example.com|
|National University Hospital||Recruiting|
|Singapore, Singapore, 164119|
|Contact: David SP Tan 65 6779 5555 firstname.lastname@example.org|
|National Cancer Centre||Recruiting|
|Contact: Wen Yee Chay, Dr 64368088|
|Principal Investigator:||David SP Tan||National University Hospital, Singapore|