ElevatION CRC101
Research type
Research Study
Full title
ElevatION:CRC-101: A Phase Ib study of PDR001 in combination with bevacizumab and mFOLFOX6 as first line therapy in patients with metastatic MSS colorectal cancer
IRAS ID
228700
Contact name
Mark Middleton
Contact email
Sponsor organisation
Novartis Pharmaceutical UK Limited
Eudract number
2017-000520-96
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 1 days
Research summary
This Phase Ib study will test whether adding an anti-PD1 antibody, called PDR001, to the monoclonal antibody bevacizumab and chemotherapy mFOLFOX6 (combination of 5-FU, leucovorin and oxaliplatin) better, worse or the same as just giving bevacizumab and mFOLFOX6
This study will be open to participants who have untreated metastatic (disease spread to other part of the body) colorectal cancer which is microsatellite stable (MSS). MSS tumour is also known as tumours with chromosomal instability
This study will consist of 2 parts:
Part 1: Safety run-in Part
Part 1 will determine whether it is safe to give a combination of PDR001 with bevacizumab and mFOLFOX6 and whether the combination is not causing any unbearable side effect. Approximately 6 to 20 patients will be treated in this part of the studyThe starting dose of PDR001 will be 400mg every 4 weeks as an infusion with an approved dose and schedule of mFOLFOX6 and bevacizumab. A different dosing schedule of PDR001 will be explored (400mg every 8 weeks) should starting dosing schedule of PDR001 will not be tolerated. Dose and schedule for bevacizumab and mFOLFOX6 will not change.
Part 2: Expansion Part
92 participants will be enrolled in this part once the safety and tolerability is confirmed in Part 1.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0272
Date of REC Opinion
1 Sep 2017
REC opinion
Further Information Favourable Opinion