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Trial record 1 of 3 for:    NCT02818426
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Universal Cancer Peptide-based Vaccination in Metastatic NSCLC (UCPVax)

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ClinicalTrials.gov Identifier: NCT02818426
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
Invectys
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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Brief Summary:

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

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : January 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: UCPVax

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.

 Drug: UCPVax


Outcome Measures
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Primary Outcome Measures :
  1. 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 :

    • Hematologic:

      • 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);

    • Non-hematologic:

      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)

  2. Dose-related immunogenicity (phase II) [ Time Frame: at day 73 ]
    Antigen-specific T cell responses measured using IFN-gamma ELISPOT.


Secondary Outcome Measures :
  1. Tumor response [ Time Frame: every 8 weeks up to 15 months ]
    Tumor response evaluated per RECIST v1.1.

  2. 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,

  3. Overall survival (OS) [ Time Frame: through study completion, an average of 2 years ]
    delay from the date of inclusion to death from any cause.

  4. 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

  5. Adverse Events according to NCI CTCAE v.4.03 [ Time Frame: through study completion, an average of 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Symptomatic brain metastases. Patients with controlled brain metastases after radiation therapy or with asymptomatic brain metastases may be included.
  • History of active autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease…)
  • 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
  • Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment
  • Pregnancy or lactating patients.
  • Patients with any medical or psychiatric condition or disease,
  • Patients under guardianship, curatorship or under the protection of justice.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Olivier ADOTEVI, Pr +33381668166 olivier.adotevi@univ-fcomte.fr
Contact: Virginie WESTEEL, Pr virginie.westeel@univ-fcomte.fr

Locations
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France
Centre Hospitalier Régional Universitaire de Besançon Recruiting
Besancon, France, 25030
Contact: Virginie WESTEEL, Pr         
Centre Georges François Leclerc Recruiting
Dijon, France, 21079
Contact: Laure FAVIER, Dr         
Hôpital Emile Muller Recruiting
Mulhouse, France
Contact: Didier DEBIEUVRE, Dr         
St Louis Hospital Recruiting
Paris, France
Contact: Luis TEIXEIRA, Pr         
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Elisabeth QUOIX, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Invectys
More Information
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Publications:

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02818426    
Other Study ID Numbers: UCPVax
2015-001712-35 ( EudraCT Number )
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
cancer immunotherapy
CD4 T lymphocyte helper
telomerase
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms