Trial Information

Summary: "Primovax" - A Phase III Trial Comparing GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Advanced Un-Resectable Pancreatic Cancer.

The trial is a Phase III, multinational, multicentre, controlled, randomised open-label trial. It will involve 520 advanced pancreatic cancer patients. Patients will be randomly assigned to receive Gemcitabine alone or GV1001 plus GM-CSF followed by addition of Gemcitabine at the time of 1st progression of disease. The experimental treatment is given prior to the current standard treatment in 50% of the patients.

Patient Inclusion Criteria:

• Ages Eligible for Study: 18 Years - 75 Years
• Genders Eligible for Study: Both
• Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas.
• Adequate hematological parameters:
  • Hemoglobin = 9.5 g/dL [SI units, 5.9 mmol/L]
  • WBC = 3000/mm3 [SI units,= 3 x 109/L]
  • Platelets = 100,000/mm3 [SI units, = 100 x 109/L]
• Adequate baseline liver function:
  • Total Bilirubin < 3x ULN and
  • Without liver metastases: AST (SGOT) = 2.5 x ULN ALT (SGPT) = 2.5 x ULN
  • With liver metastases: AST (SGOT) = 5 x ULN ALT (SGPT) = 5 x ULN
• Serum creatinine = 1.5 mg/dL [SI units, 132 µmol/L].
• Performance status ECOG 0-1.
• Male or female 18 - 75 years inclusive.
• Minimum life expectancy of 3 months.
• Written informed consent.

• Treatment with chemotherapy for pancreatic cancer.
• Treatment with other investigational drugs within the last 4 weeks prior to inclusion
• Immune-suppressive therapy < 4 weeks prior to inclusion
• Chronic corticosteroid use except for asthma inhalers / topical use
• Radiotherapy within 8 weeks of randomisation.
• Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix.
• Known diagnosis of HIV (AIDS), Hepatitis B, C.
• Known history of or co-existing autoimmune disease.
• Known CNS metastases.
• Clinically significant serious disease or organ system disease not currently controlled on present therapy.
• Pregnancy or lactation.
• Women of childbearing potential not using reliable and adequate contraceptive methods*
• Known sensitivity to any components of vaccine, gemcitabine or GM-CSF.
• Unable for any other reason to comply with the protocol (treatment or assessments).

*Adequate contraceptive methods are defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.