Universal Cancer Peptide-based Vaccination in Metastatic NSCLC (UCPVax)
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|ClinicalTrials.gov Identifier: NCT02818426|
Recruitment Status : Active, not recruiting
First Posted : June 29, 2016
Last Update Posted : May 11, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Non-small Cell Lung Cancer||Drug: UCPVax||Phase 1 Phase 2|
UCPVax study is a prospective multicenter phase I/II study: 54 patients with metastatic NSCLC will be enrolled in 5 centers in France.
A translational research program will be performed to better define the eligibility criteria and predictive biomarkers needed for randomized phase II and Phase III trials.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anticancer Therapeutic Vaccination Using Telomerase-derives Universal Cancer Peptides in Metastatic Non Small Cell Lung Cancer : A Phase I/II Study|
|Actual Study Start Date :||April 20, 2016|
|Estimated Primary Completion Date :||May 30, 2022|
|Estimated Study Completion Date :||December 20, 2023|
UCPVax is a therapeutic cancer vaccine composed of two peptides called UCP2 and UCP4 derived from telomerase combined with Montanide ISA 51 VG as adjuvant.
The two peptides UCP2 and UCP4 will be emulsified in Montanide ISA 51 and injected subcutaneously in separate sites (one site per peptide), at days 1, 8, 15, 29, 36 and 43 (priming phase) following by boost vaccination every 8 weeks for 12 months.
- Dose Limiting Toxicity (DLT) of UCPVax (phase I) [ Time Frame: until day 57 after the first vaccination ]
The following adverse events graded according to CTCAE v 4.03 will be classified as DLTs :
- Grade 4 neutropenia (ANC <0.5 x 109/L) lasting >5 days;
- Febrile neutropenia (defined as neutropenia ≥Grade 3 [ANC <1000 cells/mm3] and a body temperature ≥38.5°C);
- Grade ≥3 thrombocytopenia (<50.0 - 25.0 x 109/L) with bleeding;
- Grade 4 thrombocytopenia (<25.0 x 109/L) >5 days;
- Grade 4 anemia (hemoglobin <6.5 g/dL or 4.0 nmol/L);
o Grade ≥3 toxicities, except for alopecia and those grade 3 events that respond to treatment (eg. grade 3 nausea, vomiting, diarrhea that responds to standard medical supportive care within 48 hours will not be considered a DLT).
Immune system disorder:
- Grade ≥2 allergic reaction (except for local reaction at the injection site : grade ≥ 3)
- Grade ≥2 autoimmune disease (colitis, thyroidis…)
- Grade ≥2 cytokine release syndrome (nausea, headache, tachycardia, hypotension, rash and shortness of breath)
- Dose-related immunogenicity (phase II) [ Time Frame: at day 73 ]Antigen-specific T cell responses measured using IFN-gamma ELISPOT.
- Tumor response [ Time Frame: every 8 weeks up to 15 months ]Tumor response evaluated per RECIST v1.1.
- Progression-free survival (PFS) [ Time Frame: through study completion, an average of 2 years ]delay from the date of inclusion to the disease progression (RECIST) or death from any cause whichever occurs first,
- Overall survival (OS) [ Time Frame: through study completion, an average of 2 years ]delay from the date of inclusion to death from any cause.
- Health related Quality of Life (QoL) [ Time Frame: through study completion, an average of 2 years ]HrQoL will be assessed using EORTC QLQ-C30 and LC13 modules specific to lung cancer
- Adverse Events according to NCI CTCAE v.4.03 [ Time Frame: through study completion, an average of 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818426
|Centre Hospitalier Régional Universitaire de Besançon|
|Besancon, France, 25030|
|Centre Georges François Leclerc|
|Dijon, France, 21079|
|Hôpital Emile Muller|
|St Louis Hospital|
|Hôpitaux Universitaires de Strasbourg|
|Strasbourg, France, 67091|