A trial of enadenotucirev for ovarian cancer (OCTAVE)
Cancer type:
Status:
Phase:
This trial was for women with ovarian cancer that had got worse after having
It was for women who had 1 of the following:
Doctors treat these cancers in the same way. When we use the term ovarian cancer in this summary we are referring to all of these.
This trial was open for women to join between 2014 and 2018. The team published the results in 2021.
More about this trial
When doctors can’t remove ovarian cancer with surgery they can use chemotherapy. This can include platinum drugs such as:
- cisplatin
- carboplatin
- oxaliplatin
But sometimes the cancer starts growing again after treatment. Researchers in this trial looked at a new treatment to help women in this situation.
Enadenotucirev is a virus. It is also known as EnAd or ColoAd1. It kills cancer cells but doesn’t affect normal cells.
Paclitaxel is a chemotherapy drug doctors can use to treat ovarian cancer.
In this trial researchers looked at enadenotucirev with paclitaxel for ovarian cancer.
The main aims of the trial were to:
- find the best dose of enadenotucirev to have by itself and to have with paclitaxel. The best dose is the highest dose without too many side effects.
- learn more about the side effects
- find out what happens to enadenotucirev in the body
- see if the combination of enadenotucirev and paclitaxel helps women with ovarian cancer
Summary of results
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 . 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.
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 () 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.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Iain McNeish
Supported by
Akamis Bio Ltd
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040