Analysis of the Modulation of the Tumor Microenvironment by MK-3475 (Pembrolizumab) Using a Systems Biology Approach (PEMSYS)

Conditions

• Metastatic Melanoma Naive to Immune Therapy in Metastatic Setting

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — DRUG
  Pembrolizumab monotherapy at 200 mg every 3 weeks for 2 years maximum.
• Pembrolizumab - additional treatment — DRUG
  Patients may be retreated for one year of additional pembrolizubmab therapy (200 mg every 3 weeks).

Study Details

This is a monocentric, prospective, interventional and translational phase II study. Metastatic melanoma (mMEL) patients who are naive to immune therapy in the metastatic setting, and for whom an anti-Programmed Cell Death-1 (PD-1) therapy is needed could be eligible. The aim of the study is to identify biological markers which allow to better understand and predict the tumor response to pembrolizumab treatment, and thus to establish more efficient treatments for selected patients. Eligible patients will be registered (n=30) and will be treated with pembrolizumab monotherapy at 200 mg every three weeks for 2 years maximum until progression, unacceptable toxicity, or withdrawal of consent, whichever happens first. Patients may be treated for up to one year of additional treatment with pembrolizumab via the Second Course Phase. Patients will be followed medically and radiographically during pembrolizumab treatment. Patients will be followed radiographically every 9 weeks (+/- 7 days) until progression and disease evaluation will be assessed by RECIST 1.1 criteria. After progression, patients will be followed every 6 months for 5 years to collect survival data.

Key Dates

Start date

Jun 1, 2018

Status verified

Feb 2023

Primary completion

Jun 1, 2026

Completion

Jun 1, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Pembrolizumab
  Pembrolizumab 200 mg will be administered intravenously every 3 weeks, for a maximum of 2 years, until progression, unacceptable toxicity, or withdrawal of consent, whichever happens first. Patients may be treated for up to one year of additional treatment with pembrolizumab via the Second Course Phase, and according to defined criteria.

Primary Outcome Measure

Identification of biomarkers using genomics and proteomics tools (single cell RNA analysis, exome sequencing, single cell profiling), multiplexed immunohistochemistry and bioinformatics. [ Time Frame: 8 years ]