Universal Cancer Peptide-based Vaccination in Metastatic NSCLC (UCPVax)

January 8, 2025 updated by: Centre Hospitalier Universitaire de Besancon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25030
        • Centre Hospitalier Régional Universitaire de Besançon
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Mulhouse, France
        • Hopital Emile Muller
      • Paris, France
        • St Louis Hospital
      • Strasbourg, France, 67091
        • Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
until day 57 after the first vaccination
Dose-related immunogenicity (phase II)
Time Frame: at day 73
Antigen-specific T cell responses measured using IFN-gamma ELISPOT.
at day 73

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response
Time Frame: every 8 weeks up to 15 months
Tumor response evaluated per RECIST v1.1.
every 8 weeks up to 15 months
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,
through study completion, an average of 2 years
Overall survival (OS)
Time Frame: through study completion, an average of 2 years
delay from the date of inclusion to death from any cause.
through study completion, an average of 2 years
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
through study completion, an average of 2 years
Adverse Events according to NCI CTCAE v.4.03
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Invectys

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2016

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimated)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCPVax
  • 2015-001712-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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