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Pancreatic Cancer, ResectedPhase 1/2NCT02261714

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

A Phase 1/2 study testing TG01 in people with Pancreatic Cancer, Resected, run by Targovax ASA at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Pancreatic Cancer, Resected
What is being tested?
TG01
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
5 sitesin 3 countries
Study dates
Dec 2012to May 2019
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 18Show fewer
  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

United Kingdom3 sites

  • Queen Elizabeth University Hospital / Edgaston /

    Birmingham, B15 2TH

  • University of Liverpool / Molecular and Clinical Cancer Medicine

    Liverpool, L69 3GA

  • University of Manchester / The Christie NHS Foundation Trust

    Manchester, M20 43 X

Other trials in United Kingdom

Norway1 site

  • Oslo University Hospital HF the Norwegian Radium Hospital

    Oslo

Other trials in Norway

Spain1 site

  • Centro Integral Oncologico Clara Campal / Hospital HM Universitario Sanchinarro

    Madrid, 28050

Other trials in Spain

About this study

Official title: A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients With Resected Adenocarcinoma of the Pancreas

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
Being tested
TG01
Keywords
Pancreatic cancer, resected, Vaccine, KRAS
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TG01Biological

    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

  • TG01Biological

    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 groups in NCT02261714
Study groupRoleWhat they receive
TG01/GM-CSF and GemcitabineExperimentalNot described
Receives: Biological: TG01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients' Safety During Study

    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

    Measured: 2 years

  2. Patients' Immune Response

    Assess the Immune response (DTH responses and Proliferative T-cell responses) up to 2 years of treatment

    Measured: During the 2 years of treatment

Secondary outcomes (1)

  1. Clinical Efficacy

    Efficacy exploring disease free survival and overall survival.

    Measured: DFS was followed for up to 2 years and OS until last patient included had been in the study for 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2014 (estimated)
  2. Study startDec 2012
  3. Primary completionMay 2019
  4. Study completionMay 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02261714
Sponsor's protocol ID
CT TG01-01
Status last verified
May 2020
First submitted
24 Mar 2014
Last updated
14 May 2020
Data monitoring committee
No

Publications

  • Gjertsen MK, Buanes T, Rosseland AR, Bakka A, Gladhaug I, Soreide O, Eriksen JA, Moller M, Baksaas I, Lothe RA, Saeterdal I, Gaudernack G. Intradermal ras peptide vaccination with granulocyte-macrophage colony-stimulating factor as adjuvant: Clinical and immunological responses in patients with pancreatic adenocarcinoma. Int J Cancer. 2001 May 1;92(3):441-50. doi: 10.1002/ijc.1205.

    PubMed 11291084

  • Weden S, Klemp M, Gladhaug IP, Moller M, Eriksen JA, Gaudernack G, Buanes T. Long-term follow-up of patients with resected pancreatic cancer following vaccination against mutant K-ras. Int J Cancer. 2011 Mar 1;128(5):1120-8. doi: 10.1002/ijc.25449.

    PubMed 20473937

  • Palmer DH, Valle JW, Ma YT, Faluyi O, Neoptolemos JP, Jensen Gjertsen T, Iversen B, Amund Eriksen J, Moller AS, Aksnes AK, Miller R, Dueland S. TG01/GM-CSF and adjuvant gemcitabine in patients with resected RAS-mutant adenocarcinoma of the pancreas (CT TG01-01): a single-arm, phase 1/2 trial. Br J Cancer. 2020 Mar;122(7):971-977. doi: 10.1038/s41416-020-0752-7. Epub 2020 Feb 17.

    PubMed 32063605

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TG01 in people with Pancreatic Cancer, Resected, run by Targovax ASA at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom, Norway, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients' Safety During Study (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02261714, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.

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