Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT02663258
Status:
WITHDRAWN
Last Update Posted:
2017-08-01
First Post:
2016-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Anti-PD-1 (Pembrolizumab) Therapy in Metastatic Melanoma (ADAPTeM)
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Study Overview
Official Title:
An Explorative Phase II Study of Anti-PD-1 (Pembrolizumab) Therapy in Metastatic Melanoma (ADAPTeM)
Status:
WITHDRAWN
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAPTeM
Brief 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
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: