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Antigen-specific Cancer Immunotherapy (TG01) and Gemcitabine as Adjuvant Therapy in Resected Pancreatic Cancer

NCT02261714 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-05-14

Study results available
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Summary

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

Conditions

  • Pancreatic Cancer, Resected

Interventions

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

BIOLOGICAL

TG01

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

Sponsors & Collaborators

  • Targovax ASA

    lead INDUSTRY

Principal Investigators

  • Daniel PALMER · University of Liverpool Molecular and Clinical Cancer Medicine /UCD Duncan Building / Daulby Street / Liverpool

  • Juan VALLE · University of Manchester / The Christie NHS Foundation Trust /Wilmslow Road / Manchester

  • Svein DUELAND · Oslo University Hospital HF / the Norwegian Radium Hospital / Ullernchausseen 70 / Oslo

  • Yuk Ting MA · Queen Elizabeth University Hospital / Edgaston / Birmingham

  • Emiliano Calvo · Centro Integral Oncologico Clara Campal / Hospital HM Universitario Sanchinarro / Madrid

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Norway
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02261714 on ClinicalTrials.gov