NCT03405454

A Multicentre Phase II Trial of Durvalumab Versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinomas

A Multicentre Phase II Randomised Trial of Durvalumab (MEDI4736) Versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinomas (MOCCA)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: Female
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Clear Cell Carcinoma

Interventions

Type	Name	Description
DRUG	durvalumab	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
DRUG	standard chemotherapy	chemotherapy treatment will be administered as per local institutional guidelines

Timeline

• Start date: 2017-10-09
• Primary completion: 2021-09-15
• Completion: 2022-03-15
• First posted: 2018-01-23
• Last updated: 2018-05-18

Locations

2 sites across 1 country: Singapore