NCT02293707

Brief Summary

GX301 is an experimental therapeutic vaccine directed against human telomerase, an enzyme playing an essential role in cancer cell proliferation. This clinical trial will test three different GX301 administration regimens in castration-resistant prostate cancer patients who have achieved response or disease stability with first-line docetaxel treatment. This is aimed at identifying an optimal vaccination regimen. The three regimens will primarily be compared for their efficacy and safety in inducing vaccine-specific immunological responses over a period of 6 months following treatment initiation. In addition, patients will be observed for the occurrence of disease progression and for their vital status up to 24 months.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Nov 2014

Typical duration for phase_2 prostate-cancer

Geographic Reach
2 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

3.8 years

First QC Date

November 14, 2014

Last Update Submit

July 21, 2020

Conditions

Prostate Cancer

Keywords

Castration-resistant prostate cancerTherapeutic vaccineTelomerase vaccine

Outcome Measures

Primary Outcomes (3)

  • Achievement of immunological response

    Days 90 and 180 following randomisation

  • Incidence of adverse events

    Up to Day 180

  • Changes from baseline in laboratory tests for immunological safety

    Days 63, 90 and 180

Secondary Outcomes (5)

  • Changes from baseline in serum prostate-specific antigen (PSA)

    Up to Day 540 or end of observation (if earlier)

  • Progression-free survival

    Up to Day 540 or end of observation (if earlier)

  • Overall survival

    Up to Day 720

  • Incidence of adverse events

    Up to Day 540 or end of observation (if earlier)

  • Changes from baseline in laboratory tests for immunological safety

    Up to Day 540 or end of observation (if earlier)

Study Arms (3)

GX301 Regimen A (8 administrations)

EXPERIMENTAL

Administration time frame: Day 1 to Day 63.

Biological: GX301

GX301 Regimen B (4 administrations)

EXPERIMENTAL

Administration time frame: Day 1 to Day 63.

Biological: GX301

GX301 Regimen C (2 administrations)

EXPERIMENTAL

Administration time frame: Day 1 to Day 63.

Biological: GX301

Interventions

GX301BIOLOGICAL

GX301 therapy consists of four human telomerase reverse transcriptase (hTERT) peptides and two adjuvants. Peptides are hTERT (540-548) Acetate, hTERT (611-626) Acetate, hTERT (672-686) Acetate and hTERT (766-780) Acetate. Adjuvants are Montanide ISA 51 VG and imiquimod 5% cream (Aldara). Each GX301 administration will consist of four intradermal injections - one injection for each hTERT peptide - given at the same time and followed by topical application of imiquimod. Each intradermal injection will consist of a fixed hTERT peptide dose, 500 µg, reconstituted as a solution and mixed with Montanide ISA 51 VG.

GX301 Regimen A (8 administrations)GX301 Regimen B (4 administrations)GX301 Regimen C (2 administrations)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented patient history
  • Histologically confirmed diagnosis of prostate cancer, with an available Gleason score.
  • Diagnosis of progressive, castration-resistant prostate cancer (CRPC), leading to inception of first-line chemotherapy with a docetaxel-based regimen.
  • Completion of chemotherapy with a cumulative delivered dose of 300 to 825 mg/m2 docetaxel.
  • Note: Pre-chemotherapy exposure to abiraterone and prednisone does not preclude eligibility, provided that both agents have been discontinued prior to initiation of docetaxel.
  • Current patient status
  • Ability to understand study-related patient information and provision of written informed consent for participation in the study.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of at least 6 months.
  • An interval ≥4 weeks elapsed from the last docetaxel administration.
  • Documented achievement of response or disease stability with docetaxel chemotherapy.
  • Absence of cancer-related symptoms suggesting clinical disease progression.
  • Current castrate testosterone level (≤50 ng/dL) due to current gonadotropin-releasing hormone (GnRH) agonist or antagonist therapy or past orchiectomy.
  • Haematology and blood chemistry tests within specified limits.
  • Successful recovery from acute toxicities from prior chemotherapy.
  • +1 more criteria

You may not qualify if:

  • Known intolerance to Montanide or imiquimod.
  • Known presence of brain metastatic disease or spinal cord compression.
  • Radiotherapy within the past 4 weeks.
  • Concomitant presence of other primary malignancy
  • Major surgery within 4 weeks prior to randomisation.
  • Cardiovascular illness or complication which, in Investigator's judgment, compromises prognosis at 6 months or prevents the patient from following study procedures.
  • Serious uncontrolled infection.
  • Known presence of active autoimmune disease.
  • Known presence of acquired, hereditary, or congenital immunodeficiency.
  • HIV infection.
  • Current need for immunosuppressive drug therapy, including systemic corticosteroids.
  • Current need for denosumab therapy. (Patients under bisphosphonate treatment are eligible).
  • Skin disease interfering with evaluation of local tolerance of GX301 injections.
  • Participation in any interventional drug or medical device study within 30 days prior to treatment start.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

S.C. di Oncologia, A.S.O. "Santi Antonio e Biagio e Cesare Arrigo"

Alessandria, 15121, Italy

Location

Oncologia Medica A, Centro di Riferimento Oncologico (CRO)

Aviano, 33081, Italy

Location

Oncologia Medica, Azienda Ospedaliero Universitaria - Policlinico Consorziale

Bari, 70124, Italy

Location

U.O.C. Urologia 1, A.O.U. Consorziale Policlinico di Bari

Bari, 70124, Italy

Location

Oncologia Medica, A.O. Spedali Civili

Brescia, 25123, Italy

Location

S.C. Oncologia Medica, Presidio Ospedaliero Busto Arsizio

Busto Arsizio, 21052, Italy

Location

IRCCS Fondazione del Piemonte per l'Oncologia (FPO)

Candiolo, 10060, Italy

Location

Clinica di Oncologia Medica, IRCCS San Martino-IST

Genova, 16132, Italy

Location

U.O. Medicina Oncologica - Ospedale San Raffaele IRCCS

Milan, 20132, Italy

Location

Unità Oncologica Medica Urogenitale, Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Dipartimento Uro-Ginecologico, IRCCS Istituto Nazionale Tumori - Fondazione Pascale

Napoli, 80131, Italy

Location

U.O.C. di Oncologia Medica, A.O.R.N. "Antonio Cardarelli"

Napoli, 80131, Italy

Location

Oncologia Medica, A.O. Universitaria San Luigi Gonzaga

Orbassano, 10043, Italy

Location

U.O. di Oncologia, AUSL di Piacenza

Piacenza, 29100, Italy

Location

Unita Oncologica, Azienda Ospedaliera S. Maria degli Angeli

Pordenone, 33170, Italy

Location

U.O.C. di Oncologia Medica, Policlinico "Le Scotte"

Siena, 53100, Italy

Location

Oncologia Medica d.U., Policlinico G.B. Rossi, A.O.U.I. Verona

Verona, 37134, Italy

Location

Medical Oncology, Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clìnic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Medical Oncology, Institut Català d'Oncologìa

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Oncología, Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Servicio de Oncologìa Médica, Hospital Universitario Ramòn y Cajal

Madrid, 28034, Spain

Location

Oncología Médica, Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Oncology, Corporaciò Sanitària Parc Taulì

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (3)

  • Fenoglio D, Traverso P, Parodi A, Tomasello L, Negrini S, Kalli F, Battaglia F, Ferrera F, Sciallero S, Murdaca G, Setti M, Sobrero A, Boccardo F, Cittadini G, Puppo F, Criscuolo D, Carmignani G, Indiveri F, Filaci G. A multi-peptide, dual-adjuvant telomerase vaccine (GX301) is highly immunogenic in patients with prostate and renal cancer. Cancer Immunol Immunother. 2013 Jun;62(6):1041-52. doi: 10.1007/s00262-013-1415-9. Epub 2013 Apr 17.

    PMID: 23591981BACKGROUND

  • Fenoglio D, Parodi A, Lavieri R, Kalli F, Ferrera F, Tagliamacco A, Guastalla A, Lamperti MG, Giacomini M, Filaci G. Immunogenicity of GX301 cancer vaccine: Four (telomerase peptides) are better than one. Hum Vaccin Immunother. 2015;11(4):838-50. doi: 10.1080/21645515.2015.1012032.

    PMID: 25714118BACKGROUND

  • Filaci G, Fenoglio D, Nole F, Zanardi E, Tomasello L, Aglietta M, Del Conte G, Carles J, Morales-Barrera R, Guglielmini P, Scagliotti G, Signori A, Parodi A, Kalli F, Astone G, Ferrera F, Altosole T, Lamperti G, Criscuolo D, Gianese F, Boccardo F. Telomerase-based GX301 cancer vaccine in patients with metastatic castration-resistant prostate cancer: a randomized phase II trial. Cancer Immunol Immunother. 2021 Dec;70(12):3679-3692. doi: 10.1007/s00262-021-03024-0. Epub 2021 Aug 5.

    PMID: 34351436DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Francesco Boccardo, MD

    DIMI, Università di Genova - Clinica di Oncologia Medica, IRCCS San Martino-IST

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2014

First Posted

November 18, 2014

Study Start

November 1, 2014

Primary Completion

August 1, 2018

Study Completion

November 1, 2019

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

IT(17)ES(7)