Last reviewed · How we verify
NCT04990479
Nous-PEV: a Novel Immunotherapy for Lung Cancer and Melanoma
Phase 1 trial testing GAd-PEV in Melanoma (Skin) in 7 participants. Terminated before completion.
5 March 2024
Quick facts
| Lead sponsor | Nouscom SRL |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 11 June 2021 |
| Primary completion | 5 March 2024 |
| Estimated completion | 5 March 2024 |
| Sites | 7 locations across Belgium, United Kingdom, Spain |
Drugs / interventions tested
Conditions studied
- Melanoma (Skin) — all drugs for Melanoma (Skin) →
- Non-Small-Cell Lung Carcinoma — all drugs for Non-Small-Cell Lung Carcinoma →
Sponsor
Nouscom SRL — full company profile →
Who can join
18 and older, any sex, with Melanoma (Skin) or Non-Small-Cell Lung Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04990479
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Melanoma (Skin)
Currently open trials in the same condition.
- NCT06643286 — Evaluation of a Personalised Survivorship Care Plan App for Patients With Melanoma · NA · recruiting
- NCT06298734 — High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial · NA · recruiting
- NCT05704647 — Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases · Phase 2 · recruiting
- NCT05492682 — START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer · Phase 1 · active not recruiting
- NCT05649683 — Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors · NA · recruiting
Other Nouscom SRL trials
Trials by the same sponsor.
- NCT04041310 — Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors · Phase 1, PHASE2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04990479 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nouscom SRL
- Last refreshed: 20 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04990479.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing