ANTICANCER THERAPEUTIC VACCINATION USING TELOMERASE-DERIVED UNIVERSAL CANCER PEPTIDES IN METASTATIC NON SMALL CELL LUNG CANCER
- Conditions
- lung cancer non-small cellTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-001712-35-FR
- Lead Sponsor
- Centre Hospitalier Régional Universitaire de Besançon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1- Male or female patients, age = 18 and = 89 years old
2- Written informed consent
3- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
4- Stage IIIB not amenable to radiotherapy or stage IV cancer according to the TNM classification (7th edition ref) or recurrent NSCLC after surgery not amenable to loco-regional therapy.
5- Pre-treated with at least 2 lines of systemic treatment (chemotherapy or targeted therapy) with a delay of at least three weeks between the last chemotherapy treatment and the first UCPVax injection, or 3 days after three last tyrosine kinase inhibitor dose and the first UCPVax injection. Chemoradiation for stage IIIB disease is considered as one treatment line.
6- At least one measurable lesion by CT scan or MRI based on RECIST criteria version 1.1
7- Performance status 0 or 1 on the ECOG scale
8- Life-expectancy > 3 months
9- Adequate hematological, hepatic, and renal function:
oHemoglobin = 10.0 g/dL
oWhite blood cells (WBC) = 3.0 x 109/L including neutrophils = 1.5 x 109/L and total lymphocytes count = 1.0 x 109/L
oPlatelets count = 100 x 109/L
oSerum alkaline phosphatase = 3 x ULN in the absence of liver or bone metastases and = 5 x ULN in patients with documented bone or liver metastases
oSerum transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] = 2.5 x ULN in the absence of liver metastases and = 5 x ULN in case of liver metastases.
oTotal bilirubin = 1.5 x ULN
oGlomerular Filtration Rate = 60 mL/min (according to Modification of the Diet in Renal Disease [MRDR] formula or Cockroft & Gault formula)
oSerum albumin = 30 g/L
10- Effective contraception during the study period and for 1 month after the last study treatment administration. Male patients with a partner at risk of pregnancy should use an appropriate contraception method.
11- Affiliation to French social security or receiving such a regime.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
1- 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
2- Symptomatic brain metastases. Patients with controlled brain metastases after radiation therapy or with asymptomatic brain metastases may be included.
3- History of autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease…)
4- Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone = 10 mg/day is allowed) for a period of at least 4 weeks and whose treatment was not stopped 1 week prior to the start of the study treatment
5- Positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C virus (HCV); presence in the serum of the antigens HBs
6- Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment
7- Pregnancy or lactating patients.
8- Patients with any medical or psychiatric condition or disease,
9- Patients under guardianship, curatorship or under the protection of justice.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Phase I<br>- To estimate the Maximum Tolerated Dose (MTD) and select the Recommended Phase II Dose (RP2D).<br>Phase II<br>- To determine the immunogenicity of UCPVax according to the dose level.<br>;Secondary Objective: Phase I<br>- To evaluate the acute immunological safety.<br>Phase II<br>- To estimate objective response rates, <br>- To estimate Progression-free survival (PFS) and overall survival,<br>- To evaluate the vaccine-induced CD4 T helper polarization <br>- To assess the efficacy of vaccine according to pre-existing antitumor immune response <br>- To assess health related quality of life <br>- To assess long-term safety<br>;Primary end point(s): Phase I : Dose Limiting Toxicity (DLT) of UCPVax<br><br>Phase II : UCP-specific CD4 T cell responses measured in peripheral blood using IFN-? ELISPOT;Timepoint(s) of evaluation of this end point: Phase I : until day 57 <br><br>Phase II : at baseline, day 29 and prior 1st and 4th boost vaccination and at the end of treatment visit
- Secondary Outcome Measures
Name Time Method