Antigen-specific Cancer Immunotherapy (TG01) and Gemcitab... | NCT02261714

NCT02261714

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
TG01/GM-CSF and Gemcitabine	Experimental		Biological: TG01

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Clinical Efficacy	Efficacy exploring disease free survival and overall survival.	DFS was followed for up to 2 years and OS until last patient included had been in the study for 3 years.

Measure	Description	Time Frame
Relationship Between (KRAS) Status and Clinical Efficacy	Relationship between KRAS status and recurrence	2 years

Eligibility Module

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

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
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

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital HF the Norwegian Radium Hospital		Oslo			Norway
Centro Integral Oncologico Clara Campal / Hospital HM Universitario Sanchinarro

PubMed Identifier	Type	Citation	Retractions
11291084	Background	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.
20473937

Arm/Group Information

ID	Title	Description
FG000	TG01/GM-CSF and Gemcitabine	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 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 surge

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	TG01/GM-CSF and Gemcitabine	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 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 surge

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Number

Events related to TG01 and /or GM-CSF

2 years

ID	Title	Description
OG000	TG01/GM-CSF and Gemcitabine	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 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 surge

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TG01/GM-CSF and Gemcitabine	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 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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 27, 2018	Apr 8, 2020	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	May 2, 2018	Apr 8, 2020	SAP_001.pdf

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms