Nivothym (EORTC-1525-LCG)
Research type
Research Study
Full title
Single-arm, multicenter, phase II study of immunotherapy in patients with type B3 thymoma and thymic carcinoma previously treated with chemotherapy - (Nivothym)
IRAS ID
244712
Contact name
Sanjay Popat
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer
Eudract number
2015-005504-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 10 days
Research summary
This study is for adults who have advanced or recurrent thymoma or thymic carcinoma who have previously been treated with chemotherapy.
Different types of treatments are currently available for patients with thymoma and thymic carcinoma. The purpose of this study is to find out if giving a new immunotherapy treatment called nivolumab is effective in controlling this type of cancer. This is measured by the length of time that participants live with the disease without it getting worse (Progression Free Survival).
The safety of nivolumab in this study population will be assessed. If an interim analysis indicates that nivolumab is safe but not effective, then this cohort will close and a new cohort will open that evaluates combining nivolumab and ipilimimab.
Thymoma and thymic cancer is rare and the cause is unknown. New therapies are needed. Immunotherapy treatment has shown promising results in other clinical trials and may be effective in controlling this type of cancer. There is no proof of this yet, which is why the study is being done.
Nivolumab is already used to treat other types of cancer. The information from this study will help doctors learn more about nivolumab as a treatment for thymoma and thymic cancer.
The study will evaluate the effects of nivolumab or nivolumab and ipilimumab using clinical examinations, regular scans and blood tests. The study has a translational research component where tumour and blood samples will also be analysed to understand theeffects of the drug.
This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation
based in Brussels.REC name
London - South East Research Ethics Committee
REC reference
18/LO/1160
Date of REC Opinion
20 Sep 2018
REC opinion
Further Information Favourable Opinion