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

NCT03534635 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-02-21

No results posted yet for this study

Summary

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.

Conditions

  • Metastatic Melanoma Naive to Immune Therapy in Metastatic Setting

Interventions

DRUG

Pembrolizumab

Pembrolizumab monotherapy at 200 mg every 3 weeks for 2 years maximum.

DRUG

Pembrolizumab - additional treatment

Patients may be retreated for one year of additional pembrolizubmab therapy (200 mg every 3 weeks).

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03534635 on ClinicalTrials.gov