A trial of enadenotucirev for ovarian cancer (OCTAVE)

The team found that treatments like enadenotucirev with paclitaxel could help women with ovarian cancer, but concluded that more research is needed. 

Trial design
This was a phase 1 trial . 38 women took part. 

There were 2 parts to this trial. In the first part the team found the best dose of enadenotucirev to give by itself. 

In the second part the team used the best dose of enadenotucirev with paclitaxel. 

Results
The team could give enadenotucirev in 2 ways as:

• an injection through a thin tube (cannula) into the cavity of the tissue lining the abdomen (the peritoneum ) 
• a drip into a vein

The team used a tube (catheter) to give enadenotucirev into the peritoneum. During the first stage of the trial there were problems with this. So they stopped giving enadenotucirev this way. For the rest of the trial all the women had it as a drip into a vein.

They gave paclitaxel as a drip into a vein. 

Of the 38 women, 20 had enadenotucirev and paclitaxel through a drip into a vein. The team looked at how well treatment worked for them. They found that out of the 20 women:

• the cancer shrunk in 2 (10%) 
• the cancer stayed the same in 7 (35%) 
• the cancer had got worse in 5 (25%)  

For 6 women, they were not able to assess how well it worked. This could have been for a number of reasons including because they stopped treatment or didn’t have a follow up scan. 

The team also looked at overall how long the women who had enadenotucirev and paclitaxel lived. They found it was just over 14 months (14.1). This is slightly longer than in other trials. However, it is difficult to draw any conclusions from it because it was a small trial.

For side effects the team looked at all the 38 women in the trial. 24 of the 38 women had at least 1 side effect that was very bad to severe. The most common side effects were:

• diarrhoea
• feeling or being sick
• tummy (abdominal) pain
• high temperature (fever)
• infections 
• a drop in blood cells 
• shortness of breath and a cough 
• tiredness (fatigue)

Conclusion
The team concluded that it was possible to give enadenotucirev as a drip into a vein but not as an injection into the peritoneum. 

Giving enadenotucirev with paclitaxel:

• was manageable and acceptable
• could help women with ovarian cancer  

The team suggest further trials are done looking at similar treatments for ovarian cancer. The team have completed another trial of enadenotucirev for people with various cancer types, but mainly colorectal cancer. 

Other research teams are looking at enadenotucirev that has been slightly changed for a number of cancer types including ovarian. 

More detailed information
There is more information about this research in the reference below. 

Please note, this article is not in plain English. It has been written for healthcare professionals and researchers.

Safety and efficacy of the tumor-selective adenovirus enadenotucirev with or without paclitaxel in platinum-resistant ovarian cancer: a phase 1 clinical trial

Victor Moreno, Maria-Pilar Barretina-Ginesta and others

Journal for Immunotherapy of Cancer, 2021. Volume 9. Pages 1-24. 

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed ) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.