CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
PolyPEPI1018 CRC Vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03391232
NCT03391232Phase 2Completed

Safety, Tolerability, Immunogenicity and Efficacy of Multiple PolyPEPI1018 Vaccinations as an Add-on Immunotherapy to the Standard-of-Care Maintenance Therapy in Subjects With Metastatic Colorectal Cancer

Treos Bio Zrt·interventional·Posted Jan 5, 2018·Updated May 26, 2022

In Brief

A Phase 2 clinical trial evaluating PolyPEPI1018 CRC Vaccine for Colorectal Cancer. Completed, enrolled 11 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly, United States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 5, 2018
Enrollment StartMay 3, 2018
Primary CompletionJul 17, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.5 years ago

Interventions

PolyPEPI1018 CRC Vaccinebiological

Colorectal Cancer Vaccine