MedTrace Logo

Nous-PEV: a Novel Immunotherapy for Lung Cancer and Melanoma

NCT04990479 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-03-20

No results posted yet for this study

Summary

From Protocol v3.0 dated 16Jun2022. This is an international, multicenter, open-label, multiple cohort, First in Human, phase 1b clinical study, designed to evaluate safety, tolerability, and immunogenicity, and to detect any preliminary evidence of anti-tumor activity of a personalized vaccine (PEV) based on GAd-PEV priming and MVA-PEV boosting, combined with SoC first-line immunotherapy using an anti-PD-1 checkpoint inhibitor in patients with unresectable stage III/IV cutaneous melanoma or with stage IV NSCLC (PDL1 ≥ 50%). The PEV vaccines will be prepared on an individual basis, following a tumor biopsy performed at the time of screening and subsequent NGS analysis, to identify patient-specific tumor mutations. Both neoantigen-encoding genetic vaccines are administered intramuscularly using 1 prime with GAd-PEV and 3 boosts with MVA-PEV in combination with the licensed programmed death receptor-1 (PD-1)-blocking antibody pembrolizumab in adult patients in patients with unresectable stage III/IV cutaneous melanoma (Cohort a) or with stage IV NSCLC (PDL1 ≥ 50%) (Cohort b).

Conditions

  • Melanoma (Skin)
  • Non-Small-Cell Lung Carcinoma

Interventions

BIOLOGICAL

GAd-PEV

Priming phase including 1 GAd-PEV administration with Standard of Care pembrolizumab (cycle 4).

BIOLOGICAL

MVA-PEV

Boosting phase including 3 boosting administrations of MVA-PEV with Standard of Care pembrolizumab (cycles 5, 6 and 7).

Sponsors & Collaborators

  • Nouscom SRL

    lead INDUSTRY

Principal Investigators

  • Sven Gogov, MD · Nouscom SRL

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-11
Primary Completion
2024-03-05
Completion
2024-03-05

Countries

  • Belgium
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT04990479 on ClinicalTrials.gov