IVAC MUTANOME Phase I Clinical Trial

NCT02035956 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-01-18

No results posted yet for this study

Summary

Clinical first-in-human study evaluating the safety, tolerability and immunogenicity of intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma

Conditions

Interventions

BIOLOGICAL

IVAC MUTANOME, RBL001/RBL002

Each patient will receive multiple repeated intranodal injections of IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002.

Sponsors & Collaborators

  • BioNTech RNA Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Ugur Sahin, Prof. Dr. · BioNTech RNA Pharmaceuticals GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-02-14
Completion
2019-10-31

Countries

  • Austria
  • Germany

Study Locations

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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 NCT02035956 on ClinicalTrials.gov