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

Primary Purpose

Metastatic Non-small Cell Lung Cancer

Status
Active
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
UCPVax
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Non-small Cell Lung Cancer focused on measuring cancer immunotherapy, CD4 T lymphocyte helper, telomerase

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Régional Universitaire de Besançon
  • Centre Georges François Leclerc
  • Hôpital Emile Muller
  • St Louis Hospital
  • Hôpitaux Universitaires de Strasbourg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UCPVax

Arm Description

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.

Outcomes

Primary Outcome Measures

Dose Limiting Toxicity (DLT) of UCPVax (phase I)
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)
Dose-related immunogenicity (phase II)
Antigen-specific T cell responses measured using IFN-gamma ELISPOT.

Secondary Outcome Measures

Tumor response
Tumor response evaluated per RECIST v1.1.
Progression-free survival (PFS)
delay from the date of inclusion to the disease progression (RECIST) or death from any cause whichever occurs first,
Overall survival (OS)
delay from the date of inclusion to death from any cause.
Health related Quality of Life (QoL)
HrQoL will be assessed using EORTC QLQ-C30 and LC13 modules specific to lung cancer
Adverse Events according to NCI CTCAE v.4.03

Full Information

First Posted
May 20, 2016
Last Updated
July 13, 2023
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Invectys
search

1. Study Identification

Unique Protocol Identification Number
NCT02818426
Brief Title
Universal Cancer Peptide-based Vaccination in Metastatic NSCLC
Acronym
UCPVax
Official Title
Anticancer Therapeutic Vaccination Using Telomerase-derives Universal Cancer Peptides in Metastatic Non Small Cell Lung Cancer : A Phase I/II Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 20, 2016 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Invectys

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Non-small Cell Lung Cancer
Keywords
cancer immunotherapy, CD4 T lymphocyte helper, telomerase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UCPVax
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
UCPVax
Primary Outcome Measure Information:
Title
Dose Limiting Toxicity (DLT) of UCPVax (phase I)
Description
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)
Time Frame
until day 57 after the first vaccination
Title
Dose-related immunogenicity (phase II)
Description
Antigen-specific T cell responses measured using IFN-gamma ELISPOT.
Time Frame
at day 73
Secondary Outcome Measure Information:
Title
Tumor response
Description
Tumor response evaluated per RECIST v1.1.
Time Frame
every 8 weeks up to 15 months
Title
Progression-free survival (PFS)
Description
delay from the date of inclusion to the disease progression (RECIST) or death from any cause whichever occurs first,
Time Frame
through study completion, an average of 2 years
Title
Overall survival (OS)
Description
delay from the date of inclusion to death from any cause.
Time Frame
through study completion, an average of 2 years
Title
Health related Quality of Life (QoL)
Description
HrQoL will be assessed using EORTC QLQ-C30 and LC13 modules specific to lung cancer
Time Frame
through study completion, an average of 2 years
Title
Adverse Events according to NCI CTCAE v.4.03
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire de Besançon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hôpital Emile Muller
City
Mulhouse
Country
France
Facility Name
St Louis Hospital
City
Paris
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26350591
Citation
Galaine J, Borg C, Godet Y, Adotevi O. Interest of Tumor-Specific CD4 T Helper 1 Cells for Therapeutic Anticancer Vaccine. Vaccines (Basel). 2015 Jun 30;3(3):490-502. doi: 10.3390/vaccines3030490.
Results Reference
background
PubMed Identifier
23032748
Citation
Dosset M, Godet Y, Vauchy C, Beziaud L, Lone YC, Sedlik C, Liard C, Levionnois E, Clerc B, Sandoval F, Daguindau E, Wain-Hobson S, Tartour E, Langlade-Demoyen P, Borg C, Adotevi O. Universal cancer peptide-based therapeutic vaccine breaks tolerance against telomerase and eradicates established tumor. Clin Cancer Res. 2012 Nov 15;18(22):6284-95. doi: 10.1158/1078-0432.CCR-12-0896. Epub 2012 Oct 2.
Results Reference
background
PubMed Identifier
22407833
Citation
Godet Y, Fabre E, Dosset M, Lamuraglia M, Levionnois E, Ravel P, Benhamouda N, Cazes A, Le Pimpec-Barthes F, Gaugler B, Langlade-Demoyen P, Pivot X, Saas P, Maillere B, Tartour E, Borg C, Adotevi O. Analysis of spontaneous tumor-specific CD4 T-cell immunity in lung cancer using promiscuous HLA-DR telomerase-derived epitopes: potential synergistic effect with chemotherapy response. Clin Cancer Res. 2012 May 15;18(10):2943-53. doi: 10.1158/1078-0432.CCR-11-3185. Epub 2012 Mar 8.
Results Reference
background
PubMed Identifier
23264913
Citation
Godet Y, Dosset M, Borg C, Adotevi O. Is preexisting antitumor CD4 T cell response indispensable for the chemotherapy induced immune regression of cancer? Oncoimmunology. 2012 Dec 1;1(9):1617-1619. doi: 10.4161/onci.21513.
Results Reference
background
PubMed Identifier
23357860
Citation
Adotevi O, Dosset M, Galaine J, Beziaud L, Godet Y, Borg C. Targeting antitumor CD4 helper T cells with universal tumor-reactive helper peptides derived from telomerase for cancer vaccine. Hum Vaccin Immunother. 2013 May;9(5):1073-7. doi: 10.4161/hv.23587. Epub 2013 Jan 28.
Results Reference
background
PubMed Identifier
36070539
Citation
Adotevi O, Vernerey D, Jacoulet P, Meurisse A, Laheurte C, Almotlak H, Jacquin M, Kaulek V, Boullerot L, Malfroy M, Orillard E, Eberst G, Lagrange A, Favier L, Gainet-Brun M, Doucet L, Teixeira L, Ghrieb Z, Clairet AL, Guillaume Y, Kroemer M, Hocquet D, Moltenis M, Limat S, Quoix E, Mascaux C, Debieuvre D, Fagnoni-Legat C, Borg C, Westeel V. Safety, Immunogenicity, and 1-Year Efficacy of Universal Cancer Peptide-Based Vaccine in Patients With Refractory Advanced Non-Small-Cell Lung Cancer: A Phase Ib/Phase IIa De-Escalation Study. J Clin Oncol. 2023 Jan 10;41(2):373-384. doi: 10.1200/JCO.22.00096. Epub 2022 Sep 7.
Results Reference
result

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Universal Cancer Peptide-based Vaccination in Metastatic NSCLC

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