A Phase II Randomised Trial of Three Regimens of GX301 Vaccination in Castration-resistant Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02293707
• Date of registration: 14/11/2014
• Prospective Registration: No
• Primary sponsor: Laboratoires Leurquin Mediolanum
• Public title: A Phase II Randomised Trial of Three Regimens of GX301 Vaccination in Castration-resistant Prostate Cancer
• Scientific 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
• Date of first enrolment: November 2014
• Target sample size: 99
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02293707
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Italy, Spain

Contacts

• Name: Francesco Boccardo, MD
• Affiliation: DIMI, Università di Genova - Clinica di Oncologia Medica, IRCCS San Martino-IST

Key inclusion & exclusion criteria

Inclusion Criteria:

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.

- Confirmation from the immunology laboratory that the blood sample provided for
baseline immunological tests is technically adequate.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Biological: GX301

Primary Outcome(s)

Changes from baseline in laboratory tests for immunological safety [Time Frame: Days 63, 90 and 180]

Incidence of adverse events [Time Frame: Up to Day 180]

Achievement of immunological response [Time Frame: Days 90 and 180 following randomisation]

Secondary Outcome(s)

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)]

Changes from baseline in serum prostate-specific antigen (PSA) [Time Frame: Up to Day 540 or end of observation (if earlier)]

Overall survival [Time Frame: Up to Day 720]

Progression-free survival [Time Frame: Up to Day 540 or end of observation (if earlier)]

Secondary ID(s)

MED-GX301-02

2014-000095-26

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Universita degli Studi di Genova