Clinical trial · Interventional
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
NCT04515043CI-TRIAL-00052036completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- INVAC-1
- 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.
- interventionNames
- Drug: INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study.
Primary outcomes (1)
- measure
- long term anti telomerase specific memory responses
- timeFrame
- 1 day visit
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.