Back to results

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

Primary Purpose

Pancreatic Cancer, Resected

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

TG01

About this trial

This is an interventional treatment trial for Pancreatic Cancer, Resected focused on measuring Pancreatic cancer, resected, Vaccine, KRAS

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oslo University Hospital HF the Norwegian Radium Hospital
Centro Integral Oncologico Clara Campal / Hospital HM Universitario Sanchinarro
Queen Elizabeth University Hospital / Edgaston /
University of Liverpool / Molecular and Clinical Cancer Medicine
University of Manchester / The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TG01/GM-CSF and Gemcitabine

Arm Description

Outcomes

Primary Outcome Measures

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

Patients' Immune Response

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

Secondary Outcome Measures

Clinical Efficacy

Efficacy exploring disease free survival and overall survival.

Full Information

NCT ID

NCT02261714

First Posted

March 24, 2014

Last Updated

May 13, 2020

Sponsor

Targovax ASA

1. Study Identification

Unique Protocol Identification Number

NCT02261714

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

May 2019 (Actual)

Study Completion Date

May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Targovax ASA

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Resected

Keywords

Pancreatic cancer, resected, Vaccine, KRAS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TG01/GM-CSF and Gemcitabine

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

TG01

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

TG01

Intervention Description

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

Primary Outcome Measure Information:

Title

Patients' Safety During Study

Description

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

Time Frame

2 years

Title

Patients' Immune Response

Description

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

Time Frame

During the 2 years of treatment

Secondary Outcome Measure Information:

Title

Clinical Efficacy

Description

Efficacy exploring disease free survival and overall survival.

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Relationship Between (KRAS) Status and Clinical Efficacy

Description

Relationship between KRAS status and recurrence

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: