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

NCT ID: NCT04515043

Last Updated: 2021-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-16

Study Completion Date

2020-12-19

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Solid Tumor, Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study.

Intervention Type DRUG

blood sampling will be drawn once in order to analyse long term memory immune response to INVAC-1 vaccine

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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blood sampling

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Invectys

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis Teixeira

Role: PRINCIPAL_INVESTIGATOR

AP-HP Paris Hospital

Locations

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Saint Louis Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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INVAC1-CT-102

Identifier Type: -

Identifier Source: org_study_id

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