Petal
Research type
Research Study
Full title
A phase Ib study of Pembrolizumab following Trans-Arterial chemoembolization in primary Liver carcinoma.
IRAS ID
223814
Contact name
David Pinato
Contact email
Sponsor organisation
Imperial College London
Eudract number
2017-000471-85
Duration of Study in the UK
3 years, 3 months, 1 days
Research summary
This study is an open label, single arm, sequential phase study evaluating safety, tolerability and preliminary efficacy of sequential Trans-Arterial chemoembolization (TACE) followed by pembrolizumab in patients with primary liver carcinoma.
TACE works in two ways to kill the tumour: by giving a high dose of chemotherapy drug directly into the tumour and by cutting off the blood supply to the tumour. Pembrolizumab is designed to help the patients’ own immune systems to attack cancer cells. Combining the two treatments together may be more effective than giving TACE alone.
The safety profile of this combination has not been explored. The primary aim of this Phase Ib study is therefore to provide confirmatory evidence of safety of pembrolizumab in combination with TACE and to preliminarily evaluate the efficacy of the combination. The study will be conducted in two parts, performed at 1-3 sites in the UK and will recruit up to of 32 patients.
The study will be conducted in two parts, performed at 1-3 sites in the UK and will recruit up to of 32 patients.Participants will be assessed up to 14 days prior to TACE to confirm eligibility and be recruited onto the trial. Once they have completed 30 days post TACE they will receive pembrolizumab every 3 weeks until radiologically confirmed disease progression, unacceptable toxicity or a maximum of 1 year of treatment has been completed.
Part 1 of the study will consist of up to 6 patients treated with pembrolizumab after TACE at the clinically recommended dose of 200 mg every 3 weeks. Participants will be observed for determination of dose limiting toxicities over a 21 day time window with weekly laboratory assessments in Cycle 1 only. The decision to undertake Part II at 200 mg dose or continue at a lower dose of 100 mg will be made by an Independent Safety Monitoring Committee. Once the dose level has been determined in part I a further 26 patients will be recruited into Part II at that dose level.
REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/1180
Date of REC Opinion
18 Oct 2017
REC opinion
Further Information Favourable Opinion