NCT02818426CompletedPhase 1/2
Universal Cancer Peptide-based Vaccination in Metastatic NSCLC
Anticancer Therapeutic Vaccination Using Telomerase-derives Universal Cancer Peptides in Metastatic Non Small Cell Lung Cancer : A Phase I/II Study
Source: ClinicalTrials.gov · Last updated 9 Jan 2025
Brief summary (registry, in English)
UCPVAx is a therapeutic vaccine based on the telomerase-derived UCP designed to induce strong TH1 CD4 T cell responses in cancer patients. Three doses of UCPVax (0,25 mg, 0,5 mg and 1 mg) will be tested in this phase I/II study by using Continuous Reassessment Method (CRML) dose escalation design model. The phase I is a dose escalation study designed to evaluate safety of use of UCPVax and to estimate its Maximum Tolerated Dose (MTD). The phase II is a dose deescalation designed to evaluate the immunogenicity of UCPVax according to the dose level.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 82 (actual)
- First submitted
- 20 May 2016
- Start date
- 20 Apr 2016
- Primary completion date
- 30 Aug 2022
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Diseases
- Lung cancer
- NCT number
- NCT02818426
- EudraCT number
- 2015-001712-35
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 82
- From 20 Apr 2016 to the primary completion date, 30 Aug 2022
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Symptomatic brain metastases. Patients with controlled brain metastases after radiation therapy or with asymptomatic brain metastases may be included.
- Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment
Other illness
- Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
- History of active autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease…)
- Patients with any medical or psychiatric condition or disease,
Lab values
- Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed) - - Positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C virus (HCV); presence in the serum of the antigens HBs
Other
- Pregnancy or lactating patients.
- Patients under guardianship, curatorship or under the protection of justice.
Who the study is looking for
- Written informed consent
- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
- Stage IIIB not amenable to radiotherapy or stage IV cancer according to the TNM classification (7th edition) or recurrent NSCLC after surgery not amenable to loco-regional therapy.
- Pre-treated with at least 2 or 3 lines of treatment (including immunotherapy). Chemoradiation for stage IIIB disease is considered as one treatment line.
- At least one measurable lesion by CT scan or MRI based on RECIST criteria version 1.1
- Performance status 0 or 1 on the ECOG scale
- Life-expectancy \> 3 months
- Adequate hematological, hepatic, and renal function
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Régional Universitaire de Besançon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Hôpital Emile Muller Coordinator of this site? Confirm its status | Mulhouse | France | Unknown status |
| St Louis Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.