Prostate CancerPhase 2NCT02293707
A Phase II Randomised Trial of Three Regimens of GX301 Vaccination in Castration-resistant Prostate Cancer
A Phase 2 study testing GX301 in people with Prostate Cancer, run by Laboratoires Leurquin Mediolanum at 24 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- GX301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Nov 2014to Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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.
- Confirmation from the immunology laboratory that the blood sample provided for baseline immunological tests is technically adequate.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
Italy17 sites
S.C. di Oncologia, A.S.O. "Santi Antonio e Biagio e Cesare Arrigo"
Alessandria, 15121
Oncologia Medica A, Centro di Riferimento Oncologico (CRO)
Aviano, 33081
Oncologia Medica, Azienda Ospedaliero Universitaria - Policlinico Consorziale
Bari, 70124
U.O.C. Urologia 1, A.O.U. Consorziale Policlinico di Bari
Bari, 70124
Oncologia Medica, A.O. Spedali Civili
Brescia, 25123
S.C. Oncologia Medica, Presidio Ospedaliero Busto Arsizio
Busto Arsizio, 21052
IRCCS Fondazione del Piemonte per l'Oncologia (FPO)
Candiolo, 10060
Clinica di Oncologia Medica, IRCCS San Martino-IST
Genova, 16132
U.O. Medicina Oncologica - Ospedale San Raffaele IRCCS
Milan, 20132
Unità Oncologica Medica Urogenitale, Istituto Europeo di Oncologia
Milan, 20141
Dipartimento Uro-Ginecologico, IRCCS Istituto Nazionale Tumori - Fondazione Pascale
Naples, 80131
U.O.C. di Oncologia Medica, A.O.R.N. "Antonio Cardarelli"
Naples, 80131
Oncologia Medica, A.O. Universitaria San Luigi Gonzaga
Orbassano, 10043
U.O. di Oncologia, AUSL di Piacenza
Piacenza, 29100
Unita Oncologica, Azienda Ospedaliera S. Maria degli Angeli
Pordenone, 33170
U.O.C. di Oncologia Medica, Policlinico "Le Scotte"
Siena, 53100
Oncologia Medica d.U., Policlinico G.B. Rossi, A.O.U.I. Verona
Verona, 37134
Spain7 sites
Medical Oncology, Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clìnic i Provincial de Barcelona
Barcelona, 08036
Medical Oncology, Institut Català d'Oncologìa
L'Hospitalet de Llobregat, Barcelona, 08907
Oncología, Hospital Universitario Gregorio Marañón
Madrid, 28007
Servicio de Oncologìa Médica, Hospital Universitario Ramòn y Cajal
Madrid, 28034
Oncología Médica, Hospital Clínico San Carlos
Madrid, 28040
Oncology, Corporaciò Sanitària Parc Taulì
Sabadell, Barcelona, 08208
About this study
Official title: A Randomised, Parallel-group, Open-label Phase II Trial of the Immunological Effects of Three Regimens of GX301 Vaccination in Castration-resistant Prostate Cancer Patients Who Have Achieved Response or Disease Stability With First-line Chemotherapy
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.
Read the detailed description
GX301, an experimental therapeutic (anti-cancer) vaccine, is composed of four immunogenic peptides from human telomerase and two complementary adjuvants, Montanide ISA-51 VG and imiquimod.
An earlier Phase 1 study of GX301 has provided evidence of vaccine-specific immune response in a small sample of stage 4 prostate cancer patients given eight GX301 administrations over 9 weeks.
The present Phase 2, randomised, parallel-group, multicentre trial is aimed at comparing three different GX301 administration regimens in patients with progressive, castration-resistant prostate cancer who have completed a first-line docetaxel treatment and have achieved response to chemotherapy or disease stability. Primary comparisons will include regimen efficacy in inducing vaccine-specific immunological responses over a period of 6 months following randomisation; and treatment safety and tolerability over the same period.
A further study aim is to investigate whether achievement of immunological response, irrespective of the assigned GX301 regimen, is related to progression-free and/or overall survival.
Eligible patients will be randomly assigned to receive one of three GX301 vaccination regimens consisting of two, four or eight administrations, respectively, each regimen being given over a fixed 9-week period. Randomisation ratio will be 1:1:1. Randomisation will be stratified by previous cumulative exposure to docetaxel.
Following randomisation, immunological responses to GX301 will be determined over a 6-month period. However, on-study patient observation will be continued until the occurrence of one of the following end-points, whichever the earliest: (a) disease progression; (b) death; (c) completion of an 18-month observation period; or (d) patient's decision to terminate his participation in the study.
All patients discharged from the trial for reasons (a) or (c) will undergo a follow-up to ascertain survival until 24 months from randomisation.
Data analysis will be carried out in two sequential steps. The first step will focus on co-primary outcomes and will therefore take place upon completion of the study dataset up to the 6-month time-point. The second step will incorporate secondary outcomes and will therefore be conducted upon completion of the full study dataset.
- Conditions
- Prostate Cancer
- Being tested
- GX301
- Keywords
- Castration-resistant prostate cancer, Therapeutic vaccine, Telomerase vaccine
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| GX301 Regimen A (8 administrations) | Experimental | Administration time frame: Day 1 to Day 63. Receives: Biological: GX301 |
| GX301 Regimen B (4 administrations) | Experimental | Administration time frame: Day 1 to Day 63. Receives: Biological: GX301 |
| GX301 Regimen C (2 administrations) | Experimental | Administration time frame: Day 1 to Day 63. Receives: Biological: GX301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of immunological response
Measured: Days 90 and 180 following randomisation
Incidence of adverse events
Measured: Up to Day 180
Changes from baseline in laboratory tests for immunological safety
Measured: Days 63, 90 and 180
Secondary outcomes (5)
Changes from baseline in serum prostate-specific antigen (PSA)
Measured: Up to Day 540 or end of observation (if earlier)
Progression-free survival
Measured: Up to Day 540 or end of observation (if earlier)
Overall survival
Measured: Up to Day 720
Incidence of adverse events
Measured: Up to Day 540 or end of observation (if earlier)
Changes from baseline in laboratory tests for immunological safety
Measured: Up to Day 540 or end of observation (if earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2018
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Leurquin Mediolanum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universita degli Studi di Genova
- Responsible party
- Sponsor
- Investigators
- Francesco Boccardo, MD, Principal investigator, DIMI, Università di Genova - Clinica di Oncologia Medica, IRCCS San Martino-IST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293707
- Sponsor's protocol ID
- MED-GX301-02
- Other IDs
- 2014-000095-26, 2014
- Status last verified
- Jul 2020
- First submitted
- 14 Nov 2014
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23591981Fenoglio 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.
PubMed 25714118Filaci 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.
PubMed 34351436
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Parallel-group, Open-label Phase II Trial of the Immunological Effects of Three Regimens of GX301 Vaccination in Castration-resistant Prostate Cancer Patients Who Have Achieved Response or Disease Stability With First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT02293707
- Acronym / sponsor ID
- MED-GX301-02
- Conditions
- Prostate Cancer
- Keywords
- Castration-resistant prostate cancer, Therapeutic vaccine, Telomerase vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Laboratoires Leurquin MediolanumIndustry (pharma, biotech, devices)
- Collaborators
- Universita degli Studi di Genova
- Study start
- Nov 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
GX301, an experimental therapeutic (anti-cancer) vaccine, is composed of four immunogenic peptides from human telomerase and two complementary adjuvants, Montanide ISA-51 VG and imiquimod.
An earlier Phase 1 study of GX301 has provided evidence of vaccine-specific immune response in a small sample of stage 4 prostate cancer patients given eight GX301 administrations over 9 weeks.
The present Phase 2, randomised, parallel-group, multicentre trial is aimed at comparing three different GX301 administration regimens in patients with progressive, castration-resistant prostate cancer who have completed a first-line docetaxel treatment and have achieved response to chemotherapy or disease stability. Primary comparisons will include regimen efficacy in inducing vaccine-specific immunological responses over a period of 6 months following randomisation; and treatment safety and tolerability over the same period.
A further study aim is to investigate whether achievement of immunological response, irrespective of the assigned GX301 regimen, is related to progression-free and/or overall survival.
Eligible patients will be randomly assigned to receive one of three GX301 vaccination regimens consisting of two, four or eight administrations, respectively, each regimen being given over a fixed 9-week period. Randomisation ratio will be 1:1:1. Randomisation will be stratified by previous cumulative exposure to docetaxel.
Following randomisation, immunological responses to GX301 will be determined over a 6-month period. However, on-study patient observation will be continued until the occurrence of one of the following end-points, whichever the earliest: (a) disease progression; (b) death; (c) completion of an 18-month observation period; or (d) patient's decision to terminate his participation in the study.
All patients discharged from the trial for reasons (a) or (c) will undergo a follow-up to ascertain survival until 24 months from randomisation.
Data analysis will be carried out in two sequential steps. The first step will focus on co-primary outcomes and will therefore take place upon completion of the study dataset up to the 6-month time-point. The second step will incorporate secondary outcomes and will therefore be conducted upon completion of the full study dataset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GX301 Regimen A (8 administrations) | Experimental | Biological: GX301Administration time frame: Day 1 to Day 63. |
| GX301 Regimen B (4 administrations) | Experimental | Biological: GX301Administration time frame: Day 1 to Day 63. |
| GX301 Regimen C (2 administrations) | Experimental | Biological: GX301Administration time frame: Day 1 to Day 63. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GX301GX301 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. | Biological | GX301 Regimen A (8 administrations), GX301 Regimen B (4 administrations), GX301 Regimen C (2 administrations) |
Primary outcome
Achievement of immunological response
Time frame: Days 90 and 180 following randomisation
Incidence of adverse events
Time frame: Up to Day 180
Changes from baseline in laboratory tests for immunological safety
Time frame: Days 63, 90 and 180
5 secondary outcomes
Changes from baseline in serum prostate-specific antigen (PSA)
Time frame: Up to Day 540 or end of observation (if earlier)
Progression-free survival
Time frame: Up to Day 540 or end of observation (if earlier)
Overall survival
Time frame: Up to Day 720
Incidence of adverse events
Time frame: Up to Day 540 or end of observation (if earlier)
Changes from baseline in laboratory tests for immunological safety
Time frame: Up to Day 540 or end of observation (if earlier)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Background: PubMed 23591981Fenoglio 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.
- Background: PubMed 25714118Fenoglio 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.
- Derived from this study: PubMed 34351436Filaci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Boccardo, MD principal investigator
DIMI, Università di Genova - Clinica di Oncologia Medica, IRCCS San Martino-IST
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GX301 in people with Prostate Cancer, run by Laboratoires Leurquin Mediolanum at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of immunological response (time frame: Days 90 and 180 following randomisation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02293707, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.