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PolyPEPI1018 Vaccine and CDx for the Treatment of Metastatic Colorectal Cancer (OBERTO)

NCT03391232 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-05-26

Study results available
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Summary

Phase I/II clinical trial investigates the safety, tolerability, immunogenicity and preliminary efficacy of multiple doses of PolyPEPI1018 CRC vaccine as an add-on treatment to the standard-of-care maintenance therapy in patients with metastatic colorectal cancer. Clinical responses will be evaluated by indiction of T cell responses, T lymphocyte infiltration in accessible biopsy sites, and by objective tumor responses. This study will also explore the accuracy of the predicted T cell responses in each patient using the candidate companion diagnostic test and the correlations between clinical responses and predicted T cell responses.

Conditions

Interventions

BIOLOGICAL

PolyPEPI1018 CRC Vaccine

Colorectal Cancer Vaccine

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • University of Pisa

    collaborator OTHER

  • Laboratory Corporation of America

    collaborator INDUSTRY

  • PPD Development, LP

    collaborator INDUSTRY

  • ImmunXperts SA

    collaborator INDUSTRY

  • Treos Bio Zrt

    lead INDUSTRY

Principal Investigators

  • Eva Vegh, MD, MDA · Treos Bio Zrt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-05-03
Primary Completion
2019-07-17
Completion
2019-07-17
FDA Drug
Yes

Countries

  • United States
  • Italy

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 NCT03391232 on ClinicalTrials.gov