NCT04990479

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

An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Nous-PEV, with Pembrolizumab, in Patients with Unresectable Stage III / IV Cutaneous Melanoma and with Stage IV NSCLC (PDL1≥ 50%)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Nouscom SRL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Overall Study Design: • This is an open-label, non-randomized, dose-confirmation and cohort expansion phase 1b first-in-human study, in which 28 patients, expandable up to 34 evaluable patients in case of DLT. Study IMPs: Nous-PEV vaccine is composed of 2 sets of IMPs: * GAd-PEV * MVA-PEV Treatment phases: A) Induction phase with pembrolizumab (cycles 1, 2 and 3). B) Priming phase including 1 GAd-PEV administration with pembrolizumab (cycle 4). C) Boosting phase including 3 boosting administrations of MVA-PEV with pembrolizumab (cycles 5, 6 and 7).

Conditions

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-06-11
• Primary completion: 2024-03-05
• Completion: 2024-03-05
• First posted: 2021-08-04
• Last updated: 2025-03-20

Locations

7 sites across 3 countries: Belgium, Spain, United Kingdom