Dose expansion mCRC trial with Lonsurf, oxaliplatin bev, and nivolumab
Research type
Research Study
Full title
Phase I dose-escalation of S95005 (TAS-102) in combination with oxaliplatin in metastatic colorectal cancer
IRAS ID
239807
Contact name
Mark Saunders
Contact email
Sponsor organisation
Servier Research and Development Ltd UK
Eudract number
2015-004894-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 14 days
Research summary
This is the part 2, DOSE EXPANSION only part of the phase I trial. The aim is to assess the safety and tolerability of a combination of anti-cancer drugs, all of which are licensed by the EMA and are on the market in the UK. Preliminary information on the effect of the treatment combination on the patients tumour size will also be followed.
Patients must have a diagnosis of metastatic colorectal cancer and will have had 1 previous line of treatment (NOT oxaliplatin) for their cancer in the metastatic setting.
Drugs to be used in the trial:
Trifluridine/tipiracil (S95005) plus oxaliplatin (at recommended dose)
taken with:
bevacizumab (COHORT A)
or
Nivolumab (COHORT B)
The PK, safety profile and anti-tumour activity of the different combinations will also be checked by a CT scan, every 4 weeks; plus an optional CT scan during the withdrawal visit.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0112
Date of REC Opinion
16 Mar 2018
REC opinion
Favourable Opinion