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

Invectys

Status and phase: Completed; Phase 1

Conditions: Solid Tumor, Adult

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04515043

INVAC1-CT-102

Details and patient eligibility

About

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).

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

INVAC-1

Experimental group

Description:

All patients have been treated by INVAC-1 vaccine during the previous phase 1 NCT02301754. No new treatment injection is required in this study.

Treatment:

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