Antigen-specific Cancer Immunotherapy (TG01) and Gemcitabine as Adjuvant Therapy in Resected Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT02261714 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 10, 2014
Last Update Posted
: October 13, 2017
|
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The purpose of this study is to investigate the effect of TG01 and Granulocyte macrophage colony stimulating factor (GM-CSF) when given in addition to gemcitabine (chemotherapy) and
- Understand any possible side effects of the additional use of TG01/GM-CSF with gemcitabine
- Investigate whether TG01/GM-CSF when given with gemcitabine can produce an immune response
- Investigate if the treatment can delay or reduce recurrence of the disease
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Cancer, Resected | Biological: TG01 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients With Resected Adenocarcinoma of the Pancreas |
Study Start Date : | December 2012 |
Estimated Primary Completion Date : | June 2018 |
Estimated Study Completion Date : | June 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: TG01/GM-CSF and Gemcitabine |
Biological: TG01
TG01 and GM-CSF will be administered on days 1, 8, 15, 22 and 36. TG01 alone will also be given on days 36 and 50 for DTH assessment. Gemcitabine will start at least 3 weeks after TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total. Once chemotherapy is completed, GM-CSF and TG01 injections will resume and will be given every 4 weeks from the end of the chemotherapy period up to week 52 (plus once at week 5 post-chemotherapy) and then every 12 weeks from week 52 to week 104. TG01 alone will be given 8 weeks after the end of chemotherapy for DTH assessment. TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections. Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes For patients not able to start TG01 quickly after surgery, the vaccination can start at the same time as the chemotherapy as long as they start within 12 weeks from surgery. Gemcitabine will start at the same time as TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total. TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections. Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes |
- Patients' safety during study [ Time Frame: 2 years ]Assess the safety (number and nature of Adverse events and laboratory data occurring during study (before, during and after chemotherapy is given) in subjects treated with the Pancreatic Cancer ASCI
- Patients' Immune response [ Time Frame: During the 2 years of treatment ]Assess the Immune response (DTH responses and Proliferative T-cell responses) up to 2 years of treatment
- Clinical Efficacy [ Time Frame: 2 years ]Efficacy exploring disease free survival and overall survival
- Relationship between (KRAS) status and clinical efficacy [ Time Frame: 2 years ]Relationship between KRAS status and recurrence

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
- Stage I or II disease (clinical stage T1-3, N0-1, M0 by AJCC staging criteria).
-
Successful surgical resection
- Complete resection (R0) or with microscopic residual disease (R1)
- Expected to receive gemcitabine monotherapy as adjuvant chemotherapy
-
Laboratory Values:
- Absolute neutrophil count ≥ 1.5 x 10^9/l
- Platelets ≥100 x 10^9/l
- Haemoglobin ≥ 9 g/dl
- Total bilirubin ≤ 1.5 x UNL
- Serum creatinine ≤ 1.5 x UNL
- Albumin ≥ 2.5 g/dl
- AST or ALT ≥ 5 x UNL
- 18 years of age or older.
- ECOG performance status (PS) of 0-1.
- Life expectancy of at least 6 months
- Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy
- Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures
Exclusion Criteria:
- Has received an investigational drug within 4 weeks prior to Trial drug administration
- Has received previous therapy for pancreatic cancer including radiation or chemotherapy (except for the primary resection or primary neoadjuvant chemotherapy).
- Is currently receiving any agent with a known effect on the immune system, unless at dose levels that are not immunosuppressive (e.g. Prednisone at 10 mg/day or less or as inhaled steroid at doses used for the treatment of asthma).
-
Has any other serious illnesses or medical conditions such as, but not limited to:
- Any uncontrolled infection
- Uncontrolled cardiac failure classification III or IV (NY Heart Association)
- Uncontrolled systemic and gastro-intestinal inflammatory conditions
- Bone marrow dysplasia
- History of auto-immune disease
- History of adverse reactions to vaccines
- Known history of positive tests for HIV/AIDS, hepatitis B or C
- Pregnant or lactating females or have no pregnancy test at baseline (postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential).
- Contraindication to gemcitabine treatment
- Have had any other malignancies within last 3 years (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer)
- Known malignant brain lesion(s)
- Are unlikely to start chemotherapy within 12 weeks of surgery (e.g. delayed wound healing, or infection, etc.)
- Are not expected to complete 6 cycles of chemotherapy
- Are planned to receive yellow fever or other live (attenuated) vaccines during the course of study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261714
Norway | |
Oslo University Hospital HF the Norwegian Radium Hospital | |
Oslo, Norway | |
Spain | |
Centro Integral Oncologico Clara Campal / Hospital HM Universitario Sanchinarro | |
Madrid, Spain, 28050 | |
United Kingdom | |
Queen Elizabeth University Hospital / Edgaston / | |
Birmingham, United Kingdom, B15 2TH | |
University of Liverpool / Molecular and Clinical Cancer Medicine | |
Liverpool, United Kingdom, L69 3GA | |
University of Manchester / The Christie NHS Foundation Trust | |
Manchester, United Kingdom, M20 43 X |
Principal Investigator: | Daniel PALMER | University of Liverpool Molecular and Clinical Cancer Medicine /UCD Duncan Building / Daulby Street / Liverpool | |
Principal Investigator: | Juan VALLE | University of Manchester / The Christie NHS Foundation Trust /Wilmslow Road / Manchester | |
Principal Investigator: | Svein DUELAND | Oslo University Hospital HF / the Norwegian Radium Hospital / Ullernchausseen 70 / Oslo | |
Principal Investigator: | Yuk Ting MA | Queen Elizabeth University Hospital / Edgaston / Birmingham | |
Principal Investigator: | Emiliano Calvo | Centro Integral Oncologico Clara Campal / Hospital HM Universitario Sanchinarro / Madrid |
Publications:
Responsible Party: | Targovax ASA |
ClinicalTrials.gov Identifier: | NCT02261714 History of Changes |
Other Study ID Numbers: |
CT TG01-01 |
First Posted: | October 10, 2014 Key Record Dates |
Last Update Posted: | October 13, 2017 |
Last Verified: | October 2017 |
Keywords provided by Targovax ASA:
Pancreatic cancer, resected Vaccine KRAS |
Additional relevant MeSH terms:
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |