Universal Cancer Peptide-based Vaccination in Metastatic NSCLC

NCT02818426 | Completed Phase 1 DMC

• 2 other identifiers: UCPVax2015-001712-35
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Non-small Cell Lung Cancer

Keywords

cancer immunotherapy; CD4 T lymphocyte helper; telomerase

Outcome Measures

Primary Outcomes (2)

• 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)

  until day 57 after the first vaccination

• Dose-related immunogenicity (phase II)

  Antigen-specific T cell responses measured using IFN-gamma ELISPOT.

  at day 73

Secondary Outcomes (5)

• Tumor response

  every 8 weeks up to 15 months

• Progression-free survival (PFS)

  through study completion, an average of 2 years

• Overall survival (OS)

  through study completion, an average of 2 years

• Health related Quality of Life (QoL)

  through study completion, an average of 2 years

• Adverse Events according to NCI CTCAE v.4.03

  through study completion, an average of 2 years

Study Arms (1)

UCPVax

EXPERIMENTAL

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

Interventions

UCPVax DRUG

UCPVax

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Invectys: collaborator

Study Sites (5)

Centre Hospitalier Régional Universitaire de Besançon

Besançon, 25030, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Hôpital Emile Muller

Mulhouse, France

Location

St Louis Hospital

Paris, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (7)

• 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.

  PMID: 26350591 BACKGROUND

• 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.

  PMID: 23032748 BACKGROUND

• 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.

  PMID: 22407833 BACKGROUND

• 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.

  PMID: 23264913 BACKGROUND

• 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.

  PMID: 23357860 BACKGROUND

• 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.

  PMID: 36070539 RESULT

• Laheurte C, Boullerot L, Ndao B, Malfroy M, Queiroz L, Guillaume P, Loyon R, Seffar E, Gravelin E, Renaudin A, Jacquin M, Meurisse A, Vernerey D, Ghiringhelli F, Godet Y, Genolet R, Jandus C, Borg C, Adotevi O. UCPVax, a CD4 helper peptide vaccine, induces polyfunctional Th1 cells, antibody response, and epitope spreading to improve antitumor immunity. Cell Rep Med. 2025 Jul 15;6(7):102196. doi: 10.1016/j.xcrm.2025.102196. Epub 2025 Jun 20.

  PMID: 40543509 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: June 29, 2016
• Study Start: April 20, 2016
• Primary Completion: August 30, 2022
• Study Completion: December 31, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)