ADAPTeM
Research type
Research Study
Full title
An exploratory phase II study of Anti-PD-1 (Pembrolizumab) in patients with advanced melanoma (ADAPTe-M)
IRAS ID
166391
Contact name
James Larkin
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2014-004327-48
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This is a single-centre Phase II study of Pembrolizumab in patients with advanced melanoma, suitable for sequential biopsies of skin or lymph node melanoma deposits. Through analysis of the biopsies reflecting the tumour environment, we aim to find markers predictive of response or resistance to Pembrolizumab therapy.
Patients who have provided consent and satisfied the eligibility criteria will undergo baseline CT scanning and blood tests. Participants will be treated with Pembrolizumab, 200mg, intravenously, every 3 weeks. Blood sampling will be performed prior to each cycle of treatment and repeat CT scanning every 9 weeks. At 6 weeks following treatment a further biopsy will be performed, unless considered no longer possible on the basis of response to treatment. Pembrolizumab will be continued as long as study participants are deriving benefit and further biopsies of progressing lesions will be performed where possible.
We aim to evaluate the safety and feasibility of obtaining serial tumour biopsies or excisions of metastatic disease during treatment with Pembrolizumab with exploration of the i) mechanistic activity of Pembrolizumab, ii) identification of intratumoural and peripheral factors limiting response, iii) identification of candidate predictive biomarker panels based on (i) and (ii) and iii).
This is a collaborative study between The Royal Marsden Hospital and University College London (UCL) Cancer Institute; the analysis of tumour specimens and blood samples will be performed at UCL.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/0640
Date of REC Opinion
23 Apr 2015
REC opinion
Unfavourable Opinion