A trial comparing nintedanib to chemotherapy for clear cell cancer of the ovary or lining of the womb (NiCCC)

Trial design
This was a phase 2 trial.  In total, 93 people joined the randomised  part of the trial. A computer put people into a treatment group. There were 2 groups: 

• half had nintedanib
• half had standard chemotherapy

Standard chemotherapy included one of the following:

• paclitaxel
• liposomal doxorubicin
• topotecan

The doctor decided which chemotherapy drug to give. 

Everyone had treatment for as long as it was working and the side effects weren’t too bad. 

Results for clear cell cancer of the ovary
The team reported the results for 91 people who had ovarian clear cell cancer. They followed everyone up for about 21 months. 

The team looked at how long before the cancer started to grow again. They found it was:

• 2.3 months for those who had nintedanib
• 1.9 months for those who had chemotherapy 

They also looked at how long people lived. This was about:

• 9 months for those who had nintedanib
• just under 5 months (4.9 months) for those who had chemotherapy 

The results for these two groups look different. But some people taking part had other treatments when they stopped the treatment in this trial. So these treatments may have helped them live longer rather than the trial treatment. 

At 16 weeks the team looked at whose cancer had gone away, got a bit better or stayed the same. They found this happened in:

• 11 out of 47 (23.4%) people who had nintedanib 
• 4 out of 44 (9.1%) people who had chemotherapy 

Results for clear cell cancer of the womb 
These results aren’t available yet. We hope to add them when they are. 

Side effects
Everyone taking part had at least one side effect. Many were mild or didn’t last long. 

The most common side effects of nintedanib included:

• liver changes
• diarrhoea
• tiredness (fatigue)
• a drop in the number of red blood cells causing breathlessness and tiredness (anaemia )

The most common side effects of chemotherapy included:

• liver changes
• tiredness (fatigue)
• sore mouth 
• a drop in the number of blood cells causing an increased risk of infection, tiredness and breathlessness, bruising or bleeding 

Conclusion
The research team concluded that nintedanib worked a bit better than chemotherapy. But it didn’t work well enough on its own to be looked at in a larger trial for clear cell ovarian cancer. 

The team say these results suggest that nintedanib could possibly be combined with other treatments for ovarian clear cell cancer. 

All trial results help doctors and researchers understand more about different cancers and the best way to treat them. 

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.

596 A randomised phase II study of nintedanib (BIBF1120) compared to chemotherapy in patients with recurrent clear cell carcinoma of the ovary or endometrium. (NICCC/ENGOT-OV36)

R Glasspool and others
International Journal of Gynecological Cancer, 2020. Volume 30, Issue supplement 4  A1–A142

Where this information comes from
We have based this summary on the information in the article above. As far as we are aware, it has not been reviewed by independent specialists (peer reviewed ) or 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.