NCT03534635

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

Active, enrolled Phase 2 Last updated 21 February 2023

What this trial tests

Phase 2 trial testing Pembrolizumab in Metastatic Melanoma Naive to Immune Therapy in Metastatic Setting in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 June 2018

Primary endpoint
1 June 2026

1 June 2026

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Vaudois
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 June 2018
Primary completion	1 June 2026
Estimated completion	1 June 2026
Sites	1 location across Switzerland

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Pembrolizumab - additional treatment — full drug profile →

Conditions studied

• Metastatic Melanoma Naive to Immune Therapy in Metastatic Setting — all drugs for Metastatic Melanoma Naive to Immune Therapy in Metastatic Setting →

Sponsor

Centre Hospitalier Universitaire Vaudois

Who can join

18 and older, any sex, with Metastatic Melanoma Naive to Immune Therapy in Metastatic Setting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Applications of single-cell sequencing in cancer research: progress and perspectives.
   Lei Y, Tang R, Xu J, Wang W, et al · · 2021 · cited 428× · PMID 34108022 · DOI 10.1186/s13045-021-01105-2
2. Tumor microenvironment enriches the stemness features: the architectural event of therapy resistance and metastasis.
   Nallasamy P, Nimmakayala RK, Parte S, Are AC, et al · · 2022 · cited 163× · PMID 36550571 · DOI 10.1186/s12943-022-01682-x
3. A census of pathway maps in cancer systems biology.
   Kuenzi BM, Ideker T. · · 2020 · cited 59× · PMID 32066900 · DOI 10.1038/s41568-020-0240-7
4. Underlying mechanisms and drug intervention strategies for the tumour microenvironment.
   Li H, Zhou L, Zhou J, Li Q, et al · · 2021 · cited 32× · PMID 33722297 · DOI 10.1186/s13046-021-01893-y
5. Lymphatic-derived oxysterols promote anti-tumor immunity and response to immunotherapy in melanoma.
   Sun M, Garnier L, Chevalier R, Roumain M, et al · · 2025 · cited 7× · PMID 39890772 · DOI 10.1038/s41467-025-55969-w