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NCT Number: NCT02818426

Universal Cancer Peptide-based Vaccination in Metastatic NSCLC

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.

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Key information

Conditions

Metastatic Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre Hospitalier Régional Universitaire de Besançon, Besançon, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UCPVax

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Invectys

Registry information

Official study title

Anticancer Therapeutic Vaccination Using Telomerase-derives Universal Cancer Peptides in Metastatic Non Small Cell Lung Cancer : A Phase I/II Study

Acronym: UCPVax

Important dates

Study start
2016
Primary completion
2022
Study completion
2024
First posted
Jun 29, 2016
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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