Clinical trial • Phase II • Oncology

MPS-112; MPS-106; MPS-213; MPS-102; MPS-216; MPS-103; MPS-215; MPS-214; D-ALA-LYS-CHA-VAL-ALA-ALA-TRP-THR-LEU-LYS-ALA-ALA-D-ALA; MPS-200 for Non-small cell lung cancer

Phase II trial of MPS-112; MPS-106; MPS-213; MPS-102; MPS-216; MPS-103; MPS-215; MPS-214; D-ALA-LYS-CHA-VAL-ALA-ALA-TRP-THR-LEU-LYS-ALA-ALA-D-ALA; MPS-200…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme | Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
23-12-2024
First CTIS Authorization Date
17-04-2025

Trial design

Randomised, cemiplimab plus ose2101 (tedopi®) versus cemiplimab +/- pemetrexed (standard maintenance arm). comparator products listed: libtayo (cemiplimab) - formulation: 350 mg concentrate for solution for infusion (product record shows maxdailydoseamount 350 mg); armisarte (pemetrexed) - 25 mg/ml concentrate for solution for infusion, dosing unit mg/m2 (product record shows maxdailydoseamount 500 mg/m2).-controlled Phase II trial across 12 sites in Italy.

Randomised
Yes
Comparator
Cemiplimab plus OSE2101 (TEDOPI®) versus cemiplimab +/- pemetrexed (standard maintenance arm). Comparator products listed: LIBTAYO (cemiplimab) - formulation: 350 mg concentrate for solution for infusion (product record shows maxDailyDoseAmount 350 mg); Armisarte (pemetrexed) - 25 mg/ml concentrate for solution for infusion, dosing unit mg/m2 (product record shows maxDailyDoseAmount 500 mg/m2).
Biomarker Stratified
True, HLA-A2 positive; ctDNA positive
Target Sample Size
90

Eligibility

Recruits 90 Vulnerable population selected in trial metadata. Signed informed consent (IC) is required prior to any trial-specific procedures ("Signed informed consent (IC) prior to any trial-specific procedures."). No assent details for minors are provided in the available record..

Vulnerable Population
Vulnerable population selected in trial metadata. Signed informed consent (IC) is required prior to any trial-specific procedures ("Signed informed consent (IC) prior to any trial-specific procedures."). No assent details for minors are provided in the available record.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed diagnosis of non-oncogene addicted advanced, locally advanced (not suitable for definitive chemoradiation therapy) or metastatic non-small-cell lung cancer (NSCLC)"}
  • {"criterion_text":"- Any patient candidate for first line chemoimmunotherapy irrespective of PD-L1 levels"}
  • {"criterion_text":"- HLA-A2 positive"}
  • {"criterion_text":"- ECOG PS 0-1"}
  • {"criterion_text":"- Signed informed consent (IC) prior to any trial-specific procedures."}

Exclusion criteria

  • {"criterion_text":"- Patients not candidate for chemoimmunotherapy"}
  • {"criterion_text":"- HLA-A2 negative"}
  • {"criterion_text":"- Symptomatic or not previously treated and not stable brain metastases. Brain metastases are allowed if asymptomatic or pretreated"}
  • {"criterion_text":"- Tumor tissue not available (archive or collected before trial inclusion)"}
  • {"criterion_text":"- Evidence of EGFR mutations or ALK or ROS1 rearrangements"}
  • {"criterion_text":"- Performance status >1 (ECOG)"}
  • {"criterion_text":"- Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma (squamous or basaloid)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Differences in ctDNA clearance rate in the two arms of treatment","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- - Overall Survival - Progression Free Survival according to RECSIT 1:1 - Overall Response Rate (ORR) according to RECSIT 1:1 --- Incidence of any grade Adverse Events measured according to NCI-CTCAE (v. 5.0) Levels of other biomarkers (including PD-L1 and TMB) during the treatments and statistical associations with other outcome measures","definition_or_measurement_approach":"Progression Free Survival and Overall Response Rate measured according to RECIST 1.1; adverse events measured according to NCI-CTCAE (v. 5.0); biomarker levels (including PD-L1 and TMB) measured during treatments with statistical association analyses."}

Recruitment

Planned Sample Size
90
Recruitment Window Months
48
Consent Approach
Signed informed consent required from participants prior to any trial-specific procedures ("Signed informed consent (IC) prior to any trial-specific procedures."). Subject information and informed consent forms are provided (documents: L1_SIS and ICF and related documents). Translations/public-title translations exist (Italian translation present); no details on assent or age-specific consent forms are provided in the available record.

Geography

Total Number Of Sites
12
Total Number Of Participants
90

Italy

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
323
Number Of Sites
12
Number Of Participants
90

Sites

Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC Oncologia
Principal Investigator Name
Francesco Agustoni
Principal Investigator Email
f.agustoni@smatteo.pv.it
Contact Person Name
Francesco Agustoni
Contact Person Email
f.agustoni@smatteo.pv.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
SOS Tumori del polmone e della pleura
Principal Investigator Name
Alessandra Bearz
Principal Investigator Email
abearz@cro.it
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
UOC Centro di Ricerca di Fase 1
Principal Investigator Name
Diego Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Cortinovis
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
UOC Oncologia
Principal Investigator Name
Lorenzo Belluomini
Principal Investigator Email
lorenzo.belluomini08@gmail.com
Contact Person Name
Lorenzo Belluomini
Contact Person Email
lorenzo.belluomini08@gmail.com
Site Name
Azienda Ospedaliera Di Perugia
Department Name
SC Oncologia Medica - Dip. Scienze Onco-Emato-Gastroenterologiche
Principal Investigator Name
Giorgio Metro
Principal Investigator Email
giulio.metro@unipg.it
Contact Person Name
Giorgio Metro
Contact Person Email
giulio.metro@unipg.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Division of Medical Oncology 2
Principal Investigator Name
Federico Cappuzzo
Principal Investigator Email
f.cappuzzo@gmail.com
Contact Person Name
Federico Cappuzzo
Contact Person Email
f.cappuzzo@gmail.com
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
UO Oncologia Medica 2
Principal Investigator Name
Marco Tagliamento
Principal Investigator Email
marco.tagliamento@unige.it
Contact Person Name
Marco Tagliamento
Contact Person Email
marco.tagliamento@unige.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncologia Clinica Sperimentale Toraco-Polmonare
Principal Investigator Name
Alessandro Morabito
Principal Investigator Email
a.morabito@istitutotumori.na.it
Contact Person Name
Alessandro Morabito
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
SSD di Patologia Toracica
Principal Investigator Name
Angelo Delmonte
Principal Investigator Email
angelo.delmonte@irst.emr.it
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Oncologia Medica
Principal Investigator Name
Hector Soto-Parra
Principal Investigator Email
hsotoparra@yahoo.it
Contact Person Name
Hector Soto-Parra
Contact Person Email
hsotoparra@yahoo.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
DIMET - SCDU Oncologia
Principal Investigator Name
Federica Biello
Principal Investigator Email
federica.biello@maggioreosp.novara.it
Contact Person Name
Federica Biello
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
SSD Oncologia Medica Toracica
Principal Investigator Name
Michele Montrone
Principal Investigator Email
m.montrone@oncologico.bari.it
Contact Person Name
Michele Montrone
Contact Person Email
m.montrone@oncologico.bari.it

Sponsor

Primary sponsor

Full Name
Fondazione Ricerca Traslazionale
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Italy

Third parties

  • {"country":"","full_name":"Regeneron Ireland Designated Activity Company (DAC)","duties_or_roles":"Monetary support","organisation_type":""}
  • {"country":"","full_name":"OSE Immunotherapeutics SA","duties_or_roles":"Monetary support","organisation_type":""}

Investigational products

Investigational Product Name
TEDOPI
Active Substance
MPS-112; MPS-106; MPS-213; MPS-102; MPS-216; MPS-103; MPS-215; MPS-214; D-ALA-LYS-CHA-VAL-ALA-ALA-TRP-THR-LEU-LYS-ALA-ALA-D-ALA; MPS-200
Modality
Peptide/protein/enzyme
Routes Of Administration
INJECTION
Route
INJECTION
Maximum Dose
80 mg
Investigational Product Name
LIBTAYO (cemiplimab)
Active Substance
CEMIPLIMAB
Modality
Monoclonal antibody
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (marketing authorisation EU/1/19/1376/001 present)
Starting Dose
350 mg (product record maxDailyDoseAmount 350 mg)
Maximum Dose
12950 mg
Investigational Product Name
Armisarte (pemetrexed)
Active Substance
PEMETREXED
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (marketing authorisation EU/1/15/1063/001 present)
Maximum Dose
18500 mg/m2 (product record maxTotalDoseAmount 18500)
Combination Treatment
Yes

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