A Multicentre Phase II Trial of Durvalumab Versus Physician's Choice

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03405454
Study type	Interventional
Source	National University Hospital, Singapore
Contact	David SP Tan
Phone	(65) 6779 5555
Email	david_sp_tan@nuhs.edu.sg
Status	Recruiting
Phase	Phase 2
Start date	October 9, 2017
Completion date	March 15, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05415098` - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas	Phase 1
Recruiting	`NCT05296512` - Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer	Phase 2
Completed	`NCT01914510` - A Study of ENMD-2076 in Ovarian Clear Cell Cancers	Phase 2
Recruiting	`NCT04104776` - A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas	Phase 1/Phase 2
Completed	`NCT03297424` - A Study of PLX2853 in Advanced Malignancies.	Phase 1
Not yet recruiting	`NCT05600998` - A Study of Camrelizumab in Combination With Anlotinib in Subjects Advanced Ovarian Clear Cell Carcinoma	N/A
Recruiting	`NCT06065462` - Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100	Phase 1/Phase 2
Recruiting	`NCT05099978` - Asian Multicenter Prospective Study of ctDNA Sequencing
Not yet recruiting	`NCT05759312` - Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma	Phase 1/Phase 2
Not yet recruiting	`NCT06279104` - A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
Terminated	`NCT02837991` - A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Renal Cell Carcinoma and Ovarian Clear Cell Carcinoma	Phase 1
Recruiting	`NCT05498597` - AMT-151 in Patients With Selected Advanced Solid Tumours	Phase 1
Recruiting	`NCT05226507` - A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer	Phase 1
Recruiting	`NCT05281471` - Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Platinum-doublet + Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (OnPrime, GOG-3076)	Phase 3
Recruiting	`NCT04735861` - Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma	Phase 2
Recruiting	`NCT02866370` - Study Of Nintedanib Compared To Chemotherapy in Patients With Recurrent Clear Cell Carcinoma Of The Ovary Or Endometrium	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms