An open-label, dose-escalation, phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC*lung01, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer (NSCLC)

Conditions

Non-small-cell lung cancer

Brief summary

Occurrence of dose-limiting toxicities (DLT) related to the administration of PDC*lung01

Detailed description

Occurrence of serious adverse events (SAEs) and adverse events (AEs), deemed as related to the association of PDC*lung01 and the anti-PD-1 therapy, monitored during study treatment until 28 days after the last dose of PDC*lung01, Occurrence of serious adverse events (SAEs) and adverse events (AEs), monitored during study treatment until 28 days after the last dose of PDC*lung01, Measurement of anti-HLA class I and II antibodies in the serum. In case of positive detection, the allelic specificity of the antibodies will be determined, Ex vivo detection and characterization of CD8+ T cells against tumor antigens borne by PDC*lung01, using flow cytometry, Objective Response Rate (according to RECIST version 1.1) for cohort B2, Objective Response Rate (according to iRECIST) for cohort B2, Progression-Free Survival at 9 months according to RECIST 1.1 and according to iRECIST from the first day of anti-PD-1 antibody administration for cohort B2

Related papers

No related papers found yet.

Interventions

DRUGALIMTA 500 mg powder for concentrate for solution for infusion

DRUGALIMTA 100 mg powder for concentrate for solution for infusion

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPDC*lung01

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of dose-limiting toxicities (DLT) related to the administration of PDC*lung01	—

Secondary

Measure	Time frame
Occurrence of serious adverse events (SAEs) and adverse events (AEs), deemed as related to the association of PDClung01 and the anti-PD-1 therapy, monitored during study treatment until 28 days after the last dose of PDClung01, Occurrence of serious adverse events (SAEs) and adverse events (AEs), monitored during study treatment until 28 days after the last dose of PDClung01, Measurement of anti-HLA class I and II antibodies in the serum. In case of positive detection, the allelic specificity of the antibodies will be determined, Ex vivo detection and characterization of CD8+ T cells against tumor antigens borne by PDClung01, using flow cytometry, Objective Response Rate (according to RECIST version 1.1) for cohort B2, Objective Response Rate (according to iRECIST) for cohort B2, Progression-Free Survival at 9 months according to RECIST 1.1 and according to iRECIST from the first day of anti-PD-1 antibody administration for cohort B2	—

Measure

Time frame

Occurrence of serious adverse events (SAEs) and adverse events (AEs), deemed as related to the association of PDC*lung01 and the anti-PD-1 therapy, monitored during study treatment until 28 days after the last dose of PDC*lung01, Occurrence of serious adverse events (SAEs) and adverse events (AEs), monitored during study treatment until 28 days after the last dose of PDC*lung01, Measurement of anti-HLA class I and II antibodies in the serum. In case of positive detection, the allelic specificity of the antibodies will be determined, Ex vivo detection and characterization of CD8+ T cells against tumor antigens borne by PDC*lung01, using flow cytometry, Objective Response Rate (according to RECIST version 1.1) for cohort B2, Objective Response Rate (according to iRECIST) for cohort B2, Progression-Free Survival at 9 months according to RECIST 1.1 and according to iRECIST from the first day of anti-PD-1 antibody administration for cohort B2

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Countries

Belgium, France, Germany, Netherlands, Poland

Outcome results

None listed