EXPLORATORY STUDY Addendum to INVAC1-CT-101 (NCT02301754)

AN EXPLORATORY FOLLOW-UP STUDY OF LONG TERM ANTI-TELOMERASE IMMUNE RESPONSE AFTER INVAC-1 VACCINATION IN PATIENTS WITH LONG TERM SURVIVAL. Addendum to INVAC1-CT-101 PROTOCOL - EUDRACT NUMBER : 2013-004369-15

This study will be an exploratory study of long term immunogenicity of INVAC-1 in patients who participated in the INVAC1-CT-101 phase I study (between 2014 and 2018).

Study Overview

• Status: Completed
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Drug: INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study.

Detailed Description

The primary goal of the study is to analyze anti-telomerase specific memory responses in blood of long term survival patients and to correlate these immune responses to their subsequent treatment since the end of INVAC1-CT-101 phase I study. Six patients are expected to participate in this study.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Saint Louis Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who participated in the phase I study and are still alive at the present time
2. Ability to provide written informed consent and to understand and comply with the requirements of the study.

Exclusion Criteria:

1. Anemia (Hgb < 7g/dL) according to L-1121-1 annexe 2 of Code de Santé Publique
2. Systolic blood pressure below 90 mm Hg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INVAC-1; All patients have been treated by INVAC-1 vaccine during the previous phase 1 NCT02301754. No new treatment injection is required in this study.	Drug: INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study.; blood sampling will be drawn once in order to analyse long term memory immune response to INVAC-1 vaccine; Other Names: blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
long term anti telomerase specific memory responses	will be measured by ELISPOT on blood of patients who were treated by INVAC-1 in the phase I NCT02301754 study and are still alive at the present time	1 day visit

Collaborators and Investigators

• Sponsor: Invectys
• Investigators: Principal Investigator: Luis Teixeira, AP-HP Paris Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): December 19, 2020
• Study Completion (Actual): December 19, 2020

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: INVAC1-CT-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No