An Open-label, Phase I/II Multicenter Clinical Trial of NECVAX-NEO1 in Addition to Anti-PD-1 or Anti-PD-L1 Monoclonal Antibody Therapy in Patients with Solid Tumors (NECVAX-NEO1-02-INT).

Conditions

Advanced solid tumors

Brief summary

Reported adverse events (AEs) and serious adverse events (SAEs)., Changes from Baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis), physical examinations, vital signs, and electrocardiograms (ECGs) during the Treatment and Follow-up periods.

Detailed description

Changes from baseline in circulating tumor DNA (ctDNA) assessments., Clinical efficacy endpoints will be determined using RECIST 1.1 and iRECIST: • Objective response rate (ORR): Cohort 1: The proportion of patients having a best overall response (BOR) of complete response (CR) or partial response (PR) relative to assessment at the Screening visit. Cohort 2: The proportion of patients having a BOR of CR or PR relative to the baseline assessment (prior to administration of NECVAX-NEO1)., Progression-free-survival (PFS), defined as the time from first NECVAX-NEO1 administration to the first of progressive disease (PD) or death., Time-to-Progression (TTP), defined as the time from first NECVAX-NEO1 administration to PD., Additional clinical outcomes: • Overall survival (OS), defined as the time from first NECVAX-NEO1 administration to death.

Related papers

No related papers found yet.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Reported adverse events (AEs) and serious adverse events (SAEs)., Changes from Baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis), physical examinations, vital signs, and electrocardiograms (ECGs) during the Treatment and Follow-up periods.	—

Secondary

Measure	Time frame
Changes from baseline in circulating tumor DNA (ctDNA) assessments., Clinical efficacy endpoints will be determined using RECIST 1.1 and iRECIST: • Objective response rate (ORR): Cohort 1: The proportion of patients having a best overall response (BOR) of complete response (CR) or partial response (PR) relative to assessment at the Screening visit. Cohort 2: The proportion of patients having a BOR of CR or PR relative to the baseline assessment (prior to administration of NECVAX-NEO1)., Progression-free-survival (PFS), defined as the time from first NECVAX-NEO1 administration to the first of progressive disease (PD) or death., Time-to-Progression (TTP), defined as the time from first NECVAX-NEO1 administration to PD., Additional clinical outcomes: • Overall survival (OS), defined as the time from first NECVAX-NEO1 administration to death.	—

Measure

Time frame

Changes from baseline in circulating tumor DNA (ctDNA) assessments., Clinical efficacy endpoints will be determined using RECIST 1.1 and iRECIST: • Objective response rate (ORR): Cohort 1: The proportion of patients having a best overall response (BOR) of complete response (CR) or partial response (PR) relative to assessment at the Screening visit. Cohort 2: The proportion of patients having a BOR of CR or PR relative to the baseline assessment (prior to administration of NECVAX-NEO1)., Progression-free-survival (PFS), defined as the time from first NECVAX-NEO1 administration to the first of progressive disease (PD) or death., Time-to-Progression (TTP), defined as the time from first NECVAX-NEO1 administration to PD., Additional clinical outcomes: • Overall survival (OS), defined as the time from first NECVAX-NEO1 administration to death.

—

Countries

Germany, Lithuania, Spain

Outcome results