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

Launched by LABORATOIRES LEURQUIN MEDIOLANUM · Nov 17, 2014

Keywords

ClinConnect Summary

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 c...

Gender

MALE

Eligibility 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.