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Phase I Study on VEGF Vaccination in Metastatic Solid Tumors

NCT02237638 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-19

No results posted yet for this study

Summary

The primary objectives of this study are to investigate the safety and tolerability profile of the therapeutic vaccine hVEGF26-104/RFASE and to determine the effective dose of hVEGF26-104/RFASE required to neutralize VEGF in serum, defined as a VEGF level below 9,0 pg/mL.

Conditions

Interventions

BIOLOGICAL

hVEGF26-104/RFASE

Three intramuscular injections on days 0, 14 and 28, followed by an observational period of 6 weeks. If hererafter VEGF is not (or no longer) neutralized in serum and there is no sign of disease progression, another booster vaccination can be given. This booster can be repeated until disease progression, death or withdrawal from the study.

Sponsors & Collaborators

  • Immunovo B.V.

    collaborator UNKNOWN

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Henk Verheul, MD PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2020-01-31
Completion
2020-01-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02237638 on ClinicalTrials.gov