Our member Ultimovacs has announced a new Phase II clinical trial for ovarian cancer patients.
DOVACC is a new clinical study from Ultimovacs that will investigate the effect of combining the cancer vaccine UV1 with a checkpoint inhibitor and a PARP inhibitor in patients with ovarian cancer.
This is the first time this type of combination treatment is tested in a clinical study. Patients with advanced ovarian cancer, who have relapsed after receiving two rounds of chemotherapy treatment are eligible for the study.
The study will be sponsored by the Nordic Society for Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU). This group is a part of the European Network of Gynaecological Oncological Trial Groups (ENGOT), which is also a part of the study.
“The collaboration with the NSGO-CTU and ENGOT is exciting for us as they are very experienced with conducting clinical trials in the field of gynaecological oncology. Their expertise and network will support the recruitment of patients at multiple participating study sites across Europe,” commented Jens Bjørheim, Chief Medical Officer at Ultimovacs.
The global pharmaceutical company AstraZeneca, will contribute with two different cancer drugs to the study. These include the checkpoint inhibitor durvalumab and the PARP inhibitor Olaparib.
Ultimovacs is evaluating the company’s universal cancer vaccine UV1 and has also received NOK 10 million from Innovation Norway.
“A key benefit of UV1 is its safety profile, which enables a triple combination study with a PD-L1 inhibitor and now for the first time also with a PARP inhibitor, in an indication in desperate need of new treatment options,” commented Carlos de Sousa, CEO of Ultimovacs.
“The evaluation of UV1, durvalumab and olaparib in this Phase II triple combination study is an important next step in changing the standard of care for patients with ovarian cancer,” added Dr. Mansoor Raza Mirza, Medical Director of the NSGO-CTU and Chair of the ENGOT.
DOVACC is a randomised study, which will include 184 patients. The study is divided into three control arms, or patient groups. The first group includes 46 patients who will receive PARP inhibitor. The second group includes 46 patients who will receive both the PARP inhibitor and the checkpoint inhibitor. The third group includes 92 patients who will receive UV1 and both AstraZeneca drugs.
The multi-centre study will be held at more than 30 hospitals in about 10 countries in Europe.
The first patient will be recruited during the first half of 2021 and results are expected in 2023.
Ultimovacs currently have a broad clinical development programme, with over 500 patients enrolled in Phase II trials.