TITAN RCC
Research type
Research Study
Full title
A phase II single arm clinical trial of a Tailored ImmunoTherapy Approach with Nivolumab in subjects with metastatic or advanced Renal Cell Carcinoma
IRAS ID
224954
Contact name
Natalie Charnley
Contact email
Sponsor organisation
AIO-Studien-gGmbH
Eudract number
2016-002307-26
Clinicaltrials.gov Identifier
47647/0001/001-0001, MHRA; 33323, CPMS ID
Duration of Study in the UK
3 years, 4 months, 30 days
Research summary
The purpose of the study is to determine whether nivolumab combined with ipilimumab is suitable for the first-line treatment of renal cell carcinoma, in particular in a graduated immune stimulation and whether this results in less potential side effects. \nImmunotherapy has been used in cancer medicine for some years. Immunotherapy has proven to be effective and generally well tolerated in several types of cancer, including renal cancer. \nSo far, the immunotherapy with nivolumab and ipilimumab stipulates exactly timed simultaneous administration of both drugs. Preliminary data shows very good efficacy, but also a higher occurrence of side effects in comparison with treatment with nivolumab alone; this is caused by the strong stimulation of the immune system. It is also known from additional studies with nivolumab that, for a number of patients, single treatment with nivolumab for renal cancer may also lead to remission of the tumour, so a combined treatment does not appear to be absolutely necessary from the start. In this study, a graduated immune stimulation with nivolumab und ipilimumab will be examined. \nThe treatment schedule of the TITAN study stipulates changing between single treatment with nivolumab and combined therapy with nivolumab plus ipilimumab as required. The choice of treatment is based on the progression of the cancer disease. This means that the more intensive immunotherapy will only be administered if the single treatment with nivolumab does not lead to a reduction in the tumour size or if progression of the cancer (tumour becomes larger or new metastases occur) is observed. This is aimed at decreasing the risk of serious side effects. It should be ensured to continue the effective immunotherapy as long as possible without having to discontinue it early because of side effects.\n
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0351
Date of REC Opinion
3 Aug 2017
REC opinion
Further Information Favourable Opinion