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Melanoma (Skin)Phase 1NCT04990479

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

A Phase 1 study testing GAd-PEV and MVA-PEV in people with Melanoma (Skin) and Non-Small-Cell Lung Carcinoma, run by Nouscom SRL at 7 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GAd-PEV and MVA-PEV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
7 sitesin 3 countries
Study dates
11 Jun 2021to 5 Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Main Inclusion Criteria for Patients in Cohorts 1a and 2a:
  • Age ≥ 18 years.
  • Patients with histologically or cytologically confirmed unresectable stage III or stage IV Cutaneous Melanoma, as per AJCC staging system (8th edition). First-line treatment-naive patients.
  • Participation in this trial will be dependent upon supplying tumor tissue from newly obtained specimen. Newly obtained biopsies of a tumor lesion, not previously irradiated, must be provided in the form of excisional biopsies, resected tissue or core needle biopsies.
  • Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1 by the local site Investigator / radiologist assessment
  • Presence of at least one lesion amenable to repeated biopsy, ideally not the one being used for measuring.
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  • Willingness to undergo a minimum of two fresh lesion biopsies (pre-treatment and on-treatment).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
  • Life expectancy of at least 12 months.
  • Adequate renal, hepatic, and hematologic functions
  • A female patient is eligible to participate if she is not pregnant and not breastfeeding
  • A male patient must agree to use an adequate contraception
  • Main Inclusion Criteria for Patients in Cohort 2b:
  • Age ≥ 18 years.
  • Histologically or cytologically confirmed stage IV squamous or non-squamous NSCLC without EGFR or ALK/ROS1 /RET genomic alteration.
  • Tumor expression with PD-L1 ≥50% tumor proportion score (TPS).
  • First-line treatment-naïve patients.
  • Participation in this trial will be dependent upon supplying tumor tissue from a newly obtained specimen. Newly obtained biopsies of a tumor lesion, not previously irradiated, must be provided in the form of excisional biopsies, resected tissue or core needle biopsies.
  • Presence of at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 as determined by the local site Investigator / radiologist assessment.
  • Presence of at least one tumor lesion amenable to repeated biopsy, if possible, ideally not the one being used for measuring.
  • Willingness to undergo a minimum of two fresh tumor biopsies (pre-treatment and on-treatment).
  • ECOG performance status 0 to 1.
  • Life expectancy of at least 6 months.
  • Adequate renal, hepatic, and hematologic functions
  • A female patient is eligible to participate if she is not pregnant and not breastfeeding
  • A male patient must agree to use a contraceptive during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.
  • Main Exclusion Criteria for patients in all Cohorts:
  • Currently receiving treatment with another investigational medicinal product.
  • Prior therapy with immune checkpoint inhibitors. Patients must not have received any investigational immunotherapy either.
  • Prior radiotherapy within 2 weeks of enrolment, or within 4 weeks of enrolment in the case of radiation to central nervous system (CNS), which requires ≥ 4-week washout.
  • Prior allogenic tissue or solid organ transplant.
  • Active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids and/or whose pulse oximetry is less than 92% "on room air".
  • Limiting cardiac criteria: prolonged QT interval or QT prolongation risk factors, clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g. complete LBBB, third degree heart block, risk of arrythmic events, ejection fraction under lower limit of normal.
  • Major (according to the Investigator's judgment) surgery within 12 weeks before enrolment.
  • Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
  • Immunosuppression including the continued use of systemic (at prednisone dose equivalent of > 10 mg) or topical steroids at or near the planned i.m. injection site or the use of immunosuppressive agents for any concurrent condition in the 4 weeks prior to first study treatment administration. Inhaled and eye drop-containing corticosteroids are permitted.
  • Previous vaccination (either therapeutic and/or prophylactic) against cancer.
  • History of autoimmune disease in the last 5 years, including any active autoimmune disease except vitiligo or childhood asthma.
  • Chronic or concurrent active infectious disease requiring systemic antibodies, antifungal, or antiviral treatment.
  • Known Medical History of human immunodeficiency virus (HIV) infection or known Medical History of acquired immunodeficiency syndrome (AIDS). HIV testing is not required unless mandated by the local health authority.
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment, or at risk for HBV reactivation
  • Known CNS metastasis and/or carcinomatous meningitis.
  • Known cerebral edema.
  • Live vaccine received within 30 days before treatment initiation.

Who cannot join

None listed.

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

Spain4 sites

  • Institut Catalá d'Oncologia ICO L'Hospitalet. Av Gran Via de L'Hospitalet 199-203. 08908 L'Hospitalet de Llobregat, Barcelona, Spain

    Barcelona, 08908

  • START Madrid - Centro Integral Oncológico Clara Campal, HM CIOCC Hospital Universitario HM Sanchinarro, 28050 Madrid. Spain

    Madrid, 28050

  • START Madrid-FJD, Hospital Fundación Jiménez Diaz Avda. Reyes Católicos 2. 28040, Madrid, Spain

    Madrid

  • Instituto de Investigación Sanitaria INCLIVA - Hospital Clínico Universitario de Valencia. Av. Blasco Ibáñez, 17 CP 46010 Valencia, Spain

    Valencia, 46010

Other trials in Spain

Belgium2 sites

  • Grand Hopital de Charleroi, Grand Rue 3, 6000 Charleroi

    Charleroi, 6000

  • UZ Leuven Hospital, Campus Gasthuisberg, Herestraat 49, 3000 Leuven

    Leuven, 3000

Other trials in Belgium

United Kingdom1 site

  • Cancer Research UK Edinburgh Centre. Western General Hospital, Edinburgh, EH4 2SP, UK

    Edinburgh, Scotland, EH4 2SP

Other trials in United Kingdom

About this study

Official title: 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%)

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).

Read the 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:

  1. Induction phase with pembrolizumab (cycles 1, 2 and 3). B) Priming phase including 1 GAd-PEV administration with pembrolizumab (cycle 4).
  2. Boosting phase including 3 boosting administrations of MVA-PEV with pembrolizumab (cycles 5, 6 and 7).
Being tested
GAd-PEV, MVA-PEV
Medical subject headings
Melanoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GAd-PEVBiological

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

  • MVA-PEVBiological

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

Study groups in NCT04990479
Study groupRoleWhat they receive
Cohort 1aExperimentalCohort 1a: 3 patients (expandable to 9) with unresectable stage III / IV Cutaneous Melanoma.
Receives: Biological: GAd-PEV; Biological: MVA-PEV
Cohort 2aExperimentalCohort 2a:13 patients with unresectable stage III / IV Cutaneous Melanoma.
Receives: Biological: GAd-PEV; Biological: MVA-PEV
Cohort 2bExperimentalCohort 2b: 12 patients with stage IV NSCLC (PDL1≥ 50%).
Receives: Biological: GAd-PEV; Biological: MVA-PEV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability: incidence of treatment- emerging adverse events. AEs characterized by type, severity (graded by CTCAE v.5.0), Timing, seriousness and relationship to study treatments.

    • Frequency, duration, and severity of adverse events (AEs) and serious adverse events (SAEs) using CTCAE v5.0 criteria.
    • Changes in vital signs and clinical evaluations.
    • Changes in clinical laboratory blood samples.
    • Dose-limiting toxicity (DLT)

    Measured: Up to 110 weeks

Secondary outcomes (2)

  1. RP2D confirmation 2. Clinical efficacy:

    RP2D confirmation based on safety and tolerability

    Measured: Up to 110 weeks

  2. Clinical efficacy

    Clinical efficacy based on Overall response rate (ORR); Best overall response (BOR); Duration of response (DoR); Progression-free survival (PFS); Overall survival (OS), all as defined in tumor imaging, RECIST 1.1

    Measured: Up to 110 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2021
  2. Study start11 Jun 2021
  3. Primary completion5 Mar 2024
  4. Study completion5 Mar 2024

Why it stopped: Terminated by Sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Treatment Cohorts of the study. Part 1: • Cohort 1a: 3 patients (expandable to 9) with unresectable stage III / IV Cutaneous Melanoma. Part 2 * Cohort 2a: 13 patients with unresectable stage III / IV Cutaneous Melanoma. * Cohort 2b:12 patients with stage IV NSCLC (PDL1≥ 50%). In all cohorts, the treatment consists of four Nous-PEV vaccine administrations in combination with pembrolizumab as SoC.
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04990479
Sponsor's protocol ID
NOUS-PEV-01
Other IDs
2019-004759-35, 2019
Status last verified
Mar 2025
First submitted
15 Jul 2021
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Leoni G, D'Alise AM, Tucci FG, Micarelli E, Garzia I, De Lucia M, Langone F, Nocchi L, Cotugno G, Bartolomeo R, Romano G, Allocca S, Troise F, Nicosia A, Lahm A, Scarselli E. VENUS, a Novel Selection Approach to Improve the Accuracy of Neoantigens' Prediction. Vaccines (Basel). 2021 Aug 9;9(8):880. doi: 10.3390/vaccines9080880.

    PubMed 34452005

  • D'Alise AM, Leoni G, Cotugno G, Siani L, Vitale R, Ruzza V, Garzia I, Antonucci L, Micarelli E, Venafra V, Gogov S, Capone A, Runswick S, Martin-Liberal J, Calvo E, Moreno V, Symeonides SN, Scarselli E, Bechter O. Phase I Trial of Viral Vector-Based Personalized Vaccination Elicits Robust Neoantigen-Specific Antitumor T-Cell Responses. Clin Cancer Res. 2024 Jun 3;30(11):2412-2423. doi: 10.1158/1078-0432.CCR-23-3940.

    PubMed 38506710

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GAd-PEV and MVA-PEV in people with Melanoma (Skin) and Non-Small-Cell Lung Carcinoma, run by Nouscom SRL at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 44 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Terminated by Sponsor). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability: incidence of treatment- emerging adverse events. AEs characterized by type, severity (graded by CTCAE v.5.0), Timing, seriousness and relationship to study treatments. (time frame: Up to 110 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04990479, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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