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

NCT02261714 | Completed Phase 1 Results

• 1 other identifier: CT TG01-01
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 5

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

Conditions

Pancreatic Cancer, Resected

Keywords

Pancreatic cancer, resected; Vaccine; KRAS

Outcome Measures

Primary Outcomes (2)

• 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

  2 years

• Patients' Immune Response

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

  During the 2 years of treatment

Secondary Outcomes (1)

• Clinical Efficacy

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

Other Outcomes (1)

• Relationship Between (KRAS) Status and Clinical Efficacy

  2 years

Study Arms (1)

TG01/GM-CSF and Gemcitabine

EXPERIMENTAL

Biological: TG01

Interventions

TG01 BIOLOGICAL

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

TG01/GM-CSF and Gemcitabine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older.
• ECOG performance status (PS) of 0-1.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Targovax ASA: lead

Study Sites (5)

Oslo University Hospital HF the Norwegian Radium Hospital

Oslo, Norway

Location

Centro Integral Oncologico Clara Campal / Hospital HM Universitario Sanchinarro

Madrid, 28050, Spain

Location

Queen Elizabeth University Hospital / Edgaston /

Birmingham, B15 2TH, United Kingdom

Location

University of Liverpool / Molecular and Clinical Cancer Medicine

Liverpool, L69 3GA, United Kingdom

Location

University of Manchester / The Christie NHS Foundation Trust

Manchester, M20 43 X, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 11291084 BACKGROUND

• 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.

  PMID: 20473937 BACKGROUND

• 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.

  PMID: 32063605 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Targovax ASA

contact@targovax.com

004721398810

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: October 10, 2014
• Study Start: December 1, 2012
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 14, 2020
• Results First Posted: May 14, 2020

Record last verified: 2020-05

Locations

ES (1); NO (1); GB (3)