GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer

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

To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.

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.

Inclusion Criteria:

1. Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas.

2. 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]

3. 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

4. Serum creatinine </= 1.5 mg/dL [SI units, 132 µmol/L].

5. Performance status ECOG 0-1.

6. Male or female 18 - 75 years inclusive.

7. Minimum life expectancy of 3 months.

8. Written informed consent.

Exclusion Criteria:

1. Treatment with chemotherapy for pancreatic cancer.

2. Treatment with other investigational drugs within the last 4 weeks prior to inclusion

3. Immune-suppressive therapy <4 weeks prior to inclusion

4. Chronic corticosteroid use except for asthma inhalers / topical use

5. Radiotherapy within 8 weeks of randomisation.

6. Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix.

7. Known diagnosis of HIV (AIDS), Hepatitis B, C.

8. Known history of or co-existing autoimmune disease.

9. Known CNS metastases.

10. Clinically significant serious disease or organ system disease not currently controlled on present therapy.

11. Pregnancy or lactation.

12. Women of childbearing potential not using reliable and adequate contraceptive methods*

13. Known sensitivity to any components of vaccine, gemcitabine or GM-CSF.

14. 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.