EXPLORATORY STUDY Addendum to INVAC1-CT-101 (NCT02301754)
Phase 1
Completed
- Conditions
- Solid Tumor, Adult
- Interventions
- Registration Number
- NCT04515043
- Lead Sponsor
- Invectys
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Patients who participated in the phase I study and are still alive at the present time
- Ability to provide written informed consent and to understand and comply with the requirements of the study.
Exclusion Criteria
- Anemia (Hgb < 7g/dL) according to L-1121-1 annexe 2 of Code de Santé Publique
- Systolic blood pressure below 90 mm Hg
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description INVAC-1 INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study. All patients have been treated by INVAC-1 vaccine during the previous phase 1 NCT02301754. No new treatment injection is required in this study.
- Primary Outcome Measures
Name Time Method long term anti telomerase specific memory responses 1 day visit 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Saint Louis Hospital
🇫🇷Paris, France