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

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

Detailed Description
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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.

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

Conditions
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Advanced Unresectable Pancreatic Cancer

Intervention / Treatment
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* Biological: GV1001
* Drug: Gemcitabine (Chemotherapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gemcitabine<br>Gemcitabine alone treatment. | Drug: Gemcitabine (Chemotherapy)<br>* Gemcitabine is given as per the Burris regime and the SmPC, i.e. 7 weeks, followed by cycles of 1 weeks rest and 3 weeks chemotherapy.<br>* Other names: Gemzar;|
| Experimental: GV1001<br>GV1001 in sequential combination with Gemcitabine | Biological: GV1001<br>* 0.56mg GV1001 day 1, 3, 5, 8, 15, 22, week 6 and every 4 weeks thereafter. When gemcitabine is add it is given in cycles of once a week for 3 weeks and 1 week. Gemcitabine is dosed as per the SmPC.<br>* Other names: INN-name: Termotide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | Time of progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced, Unresesctable, Adenocarcinoma, Pancreatic cancer