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IMA970A Plus CV8102 in Very Early, Early and Intermediate Stage Hepatocellular Carcinoma Patients

NCT03203005 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-02-05

No results posted yet for this study

Summary

This study is being carried out in order to evaluate a new cancer vaccine called IMA970A combined with CV8102, a new adjuvant for the treatment of liver cancer (hepatocellular carcinoma). It will be investigated whether IMA970A and CV8102 is safe and can trigger an immune response against the tumor, which may prevent the tumor (cancer) from recurring or spreading or may even lead to tumor shrinkage following the standard treatments the patients have previously received.

Conditions

Interventions

DRUG

IMA970A plus CV8102 and Cyclophosphamide

Study treatment starts with a single intravenous infusion of 300mg/m2 Cyclophosphamide. Three days later patients start vaccination therapy with IMA970A plus CV8102 Each vaccination consists of a dose of 6.80 milligrams (mg) IMA970A (containing approx. 400 micrograms \[µg\] of each individual peptide) followed by a dose of 50 µg CV8102. First IMA970A is injected intradermally (i.d.) and about 10 minutes later CV8102 is injected i.d. at the same vaccination site in close proximity. Patients will receive 4 vaccinations at weekly intervals followed by 5 vaccinations at 3-weekly intervals for a total duration of about 4.5 months.

Sponsors & Collaborators

  • Immatics Biotechnologies GmbH

    collaborator INDUSTRY

  • CureVac

    collaborator INDUSTRY

  • European Commission

    collaborator OTHER

  • National Cancer Institute, Naples

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • Belgium
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03203005 on ClinicalTrials.gov