NCT02663258

A Study of Anti-PD-1 (Pembrolizumab) Therapy in Metastatic Melanoma (ADAPTeM)

An Explorative Phase II Study of Anti-PD-1 (Pembrolizumab) Therapy in Metastatic Melanoma (ADAPTeM)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Abbreviated Title: An explorative Phase II study of Anti-PD-1 (Pembrolizumab) in patients with advanced melanoma (ADAPTeM) Trial Phase: Phase II Clinical Indication: Stage III unresectable/stage IV metastatic melanoma Trial Type: Exploratory Phase II trial Route of administration: Intravenous Pembrolizumab, 200mg, 3weekly Trial Blinding: Unblinded; open label Phase II study Treatment Groups: All participants treated with Pembrolizumab, 200mg iv, 3weekly Number of trial subjects: 40 Estimated duration of trial: 24 months Duration of Participation: 24 months

Detailed description

This is a single arm, single agent, open label, exploratory translational research study in patients with unresectable stage III or stage IV melanoma being treated with Pembrolizumab. Suitable patients will undergo serial surgical core biopsies (nonradiological) of subcutaneous or lymph node metastases (as judged by an Oncological Surgical Consultant). As a primary endpoint, the investigators will assess the safety and feasibility of undergoing these biopsies within the patient cohort. A total of forty patients will be recruited over a period of two years. Patients who have provided consent and satisfied the eligibility criteria will undergo baseline CT scanning and peripheral blood sampling. At baseline, biopsies of suitable metastatic lesions will be undertaken and samples sent for histopathological assessment and analysis of molecular and immune parameters. Participants will be treated with Pembrolizumab, 200mg, intravenously, every 3 weeks. At 6 weeks following commencement of Pembrolizumab therapy, a further biopsy or excision of metastatic disease will be performed, unless considered no longer possible on the basis of a near or complete response to treatment. Blood sampling will be performed prior to each cycle and repeat CT scanning will occur every 9 weeks. Response evaluations will be performed according to RECIST 1.1 criteria. Pembrolizumab will be continued as long as study participants are deriving benefit and further biopsies of progressing lesions will be performed where possible. The investigators 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) use of circulating free DNA (cfDNA) as a surrogate marker of response and guide to duration of therapy.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-07-19
• Completion: 2017-07-19
• First posted: 2016-01-26
• Last updated: 2017-08-01