OpACIN-neo

• Research type

  Research Study

• Full title

  Multicenter Phase 2 Study to Identify of the Optimal neo-Adjuvant Combination Scheme of Ipilimumab and Nivolumab (OpACIN-neo)

• IRAS ID

  219798

• Contact name

  Christian Blank-de Hoop

• Contact email

  c.blank@nki.nl

• Sponsor organisation

  Antoni van Leeuwenhoek Hospital

• Eudract number

  2016-001984-35

• Clinicaltrials.gov Identifier

  NCT02977052

• Duration of Study in the UK

  0 years, 8 months, 29 days

• Research summary

  This study is carried out at an international level, in 6 different melanoma centres (The Royal Marsden is the only centre in the UK).

  The purpose of this study is to test the safety of three different combinations of nivolumab and ipilimumab. In addition, the study wants to see which of the three combinations works best. The study also looks at whether the drugs in the study can prevent the tumour from coming back, and what effect the drug has on your immune system.

  The study treats patients with melanoma which has only spread to the lymph glands (stage III melanoma) with immunotherapy before surgery. At the time that these patients receive their diagnosis, the melanoma is often already spread to other parts of the body. These small metastases are invisible on scans (CT or PET/CT). As a result, in half of these patients, the tumour comes back after the operation. By giving immunotherapy followed by the operation, we hope to reduce the chance of the tumour coming back.

  In this study, we are testing a combination of immunotherapies, namely ipilimumab (anti-CTLA-4, YervoyTM) combined with nivolumab (anti-PD-1 Opdivo™), administered from 6 weeks before the operation. Both are antibodies (human proteins) which can help the natural defence system of the body (immune system) attack the tumour cells.

  In addition to the study into how well these treatments work, we also want to find out how the body responds to the treatment. This is done by taking blood samples and samples of the tumour tissue.
  Blood samples
  Tumour tissue
  Scans

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  18/LO/0014

• Date of REC Opinion

  26 Feb 2018

• REC opinion

  Further Information Favourable Opinion