NICO
Research type
Research Study
Full title
NICO - CA209-891: Neoadjuvant and adjuvant nivolumab as Immune Checkpoint inhibition in Oral cavity cancer
IRAS ID
235386
Contact name
Joseph Sacco
Contact email
Sponsor organisation
The Clatterbridge Cancer Centre NHS Foundation Trust
Eudract number
2017-005015-13
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
Research Summary:
Mouth cancer is usually treated with surgery, often followed by radiation therapy with or without chemotherapy. Unfortunately despite this treatment, it recurs or spreads in about half of patients. Recently, a drug called nivolumab which is given into a vein via a drip, has been shown to be of benefit where the cancer has spread and worsened following treatment with chemotherapy. This drug stimulates the immune system and when it works, often does so for a long period of time. In this trial we aim to use this drug to reduce the chances of the cancer coming back after surgery and radiotherapy. We will give a single dose of the drug before surgery and again after surgery, but before radiotherapy. After radiotherapy has completed we will treat with 6 further doses. The study will assess if this treatment leads to a reduction in the cancer recurring which will be monitored by scanning every 4 months for a year, after which follow up will be as standard for each institution.
Summary of results:
Cancers of the inside of the mouth are usually treated initially with surgery and, if more advanced with additional radiotherapy. The radiotherapy is given in combination with chemotherapy if there are indications of the cancer being more aggressive. However, recently there has been increasing interest in the use of drugs that can stimulate the immune system and help gain better and longer control over the cancer if it has spread. This kind of treatment is called immunotherapy. The NICO study was set up to see if the use of nivolumab (a form of immunotherapy) used before surgery, after surgery, but before radiotherapy, and after surgery for 6 months can improve outcomes for patients. We had intended to enrol 120 patients to the study, but had to stop the study early due a decision on the part of the funder. Recruitment to the study had been slower than expected partly due to the COVID pandemic. At the end of recruitment we had only enrolled 23 patients (14 male/9 female) and had opened 3 sites. Of the 23 patients, 1 withdrew before surgery, and two did not proceed with surgery; with a further three patients withdrawing after surgery and before radiotherapy. Of the remaining 17 patients, nine underwent radiotherapy only and 8 both radiotherapy and chemotherapy, and then went onto start adjuvant nivolumab. Seven patients completed all treatment doses with nivolumab. Of the 20 patients who remained on study and had surgery, 17 (85%) had no evidence of cancer at one year. In those who had radiotherapy the percentage was 89% (8/9), and 88% (7/8) in those who had chemotherapy and radiotherapy. This was one of the main endpoints of the study (that is, the main things we were looking to understand). From previous trials we expected the one year disease free survival to be only around 65% in the patients who needed chemotherapy and radiotherapy; and the outcome we observed suggests that the addition of nivolumab increases disease free survival. However, the number of patients was too small to be sure of this. We also looked at side effects from the nivolumab which were similar to what we would expect with this drug, Complications of surgery were not higher than expected so we don’t think that the nivolumab pre-treatment led to more difficult surgery. Cancer and blood samples were collected which are being analysed further and will hopefully help us understand the role of immunotherapy in this setting.
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REC name
London - Harrow Research Ethics Committee
REC reference
18/LO/0368
Date of REC Opinion
18 May 2018
REC opinion
Further Information Favourable Opinion