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Trial record 4 of 6 for:    Targovax

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02261714
Recruitment Status : Completed
First Posted : October 10, 2014
Results First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Targovax ASA

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE October 10, 2014
Results First Submitted Date  ICMJE April 8, 2020
Results First Posted Date  ICMJE May 14, 2020
Last Update Posted Date May 14, 2020
Study Start Date  ICMJE December 2012
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2015)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
  • Patients' Safety During Study [ Time Frame: 2 years ]
    Assess the safety (number and nature of Adverse events and laboratory data occurring during study (before and during 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2020)
Clinical Efficacy [ Time Frame: DFS was followed for up to 2 years and OS until last patient included had been in the study for 3 years. ]
Efficacy exploring disease free survival and overall survival.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
Efficacy on disease recurrence [ Time Frame: 2 years ]
Efficacy will be assessed looking at disease free survival and overall survival.
Current Other Pre-specified Outcome Measures
 (submitted: June 29, 2015)
Relationship Between (KRAS) Status and Clinical Efficacy [ Time Frame: 2 years ]
Relationship between KRAS status and recurrence
Original Other Pre-specified Outcome Measures
 (submitted: October 7, 2014)
Relationship between (KRAS) status and recurrence [ Time Frame: 2 years ]
Relationship between KRAS status and recurrence
 
Descriptive Information
Brief Title  ICMJE Antigen-specific Cancer Immunotherapy (TG01) and Gemcitabine as Adjuvant Therapy in Resected Pancreatic Cancer
Official Title  ICMJE A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients With Resected Adenocarcinoma of the Pancreas
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer, Resected
Intervention  ICMJE
  • 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

Study Arms  ICMJE Experimental: TG01/GM-CSF and Gemcitabine
Interventions:
  • Biological: TG01
  • Biological: TG01
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2015)
32
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2014)
24
Actual Study Completion Date  ICMJE May 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
  2. Stage I or II disease (clinical stage T1-3, N0-1, M0 by AJCC staging criteria).
  3. Successful surgical resection

    • Complete resection (R0) or with microscopic residual disease (R1)
    • Expected to receive gemcitabine monotherapy as adjuvant chemotherapy
  4. 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
  5. 18 years of age or older.
  6. ECOG performance status (PS) of 0-1.
  7. Life expectancy of at least 6 months
  8. Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy
  9. Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures

Exclusion Criteria:

  1. Has received an investigational drug within 4 weeks prior to Trial drug administration
  2. Has received previous therapy for pancreatic cancer including radiation or chemotherapy (except for the primary resection or primary neoadjuvant chemotherapy).
  3. 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).
  4. 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
  5. Known history of positive tests for HIV/AIDS, hepatitis B or C
  6. 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).
  7. Contraindication to gemcitabine treatment
  8. Have had any other malignancies within last 3 years (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer)
  9. Known malignant brain lesion(s)
  10. Are unlikely to start chemotherapy within 12 weeks of surgery (e.g. delayed wound healing, or infection, etc.)
  11. Are not expected to complete 6 cycles of chemotherapy
  12. Are planned to receive yellow fever or other live (attenuated) vaccines during the course of study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02261714
Other Study ID Numbers  ICMJE CT TG01-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Targovax ASA
Study Sponsor  ICMJE Targovax ASA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Targovax ASA
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP