Pancreatic Cancer, post resection R0/R1 status, with tumor sequence confirmation of Ras mutations MedDRA version: 17.0 Level: LLT Classification code 10033575 Term: Pancreas cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: GI-4000 series of products
Product Code: GI-4014, GI-4015, GI-4016, GI-4020
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: GI-4014, GI-4015, GI-4016, GI-4020
CAS Numb
Sponsors
GlobeImmune, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Subjects must have resectable pancreas cancer, ductal adenocarcinoma type, with post-resection confirmation of non-metastatic disease. 2 Confirmed product related mutation in Ras from tumor sample. 3 ECOG performance status (PS) of =2 prior to randomization. 4 Confirmed R0 or R1 status post-resection. 5 Negative scratch test (immediate hypersensitivity, IgE mediated) to S. cerevisiae. 6 Age =18 years. 7 Signed, written, informed consent from the patient or legal representative before any study-specific procedures are performed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1 Non-resectable pancreatic cancer, or histologic types other than ductal adenocarcinoma (e.g. papillary cystoadenocarcinoma, mucinous cystoadenocarcinoma). Tumors classified as T4. 2 Prior chemotherapy, radiation therapy, targeted therapy, or immunotherapy for pancreatic cancer. 3 History of another cancer within the last 5 years with the exception of localized basal or squamous cell carcinoma of the skin, Stage 1A cervical cancer, or melanoma in situ. 4 History of splenectomy. 5 History of Crohn’s disease or ulcerative colitis. 6 History of major organ transplantation. 7 Concurrent and chronic therapy with corticosteroids (greater than 10 mg per day of prednisone or an equipotent dose of another corticosteroid) or any other immunosuppressive drugs. Use of dexamethasone as an antiemetic during gemcitabine dosing will be permitted during the trial. 8 History of allergy to S. cerevisiae. 9 Presence of an unstable or poorly controlled medical condition that in the opinion of the principal investigator may impair the ability of the subject to participate safely or to potentially benefit from the study. 10 Pregnancy and nursing mothers. 11 Alcohol and/or IV drug abuse within the past year. 12 Participation in any experimental treatment protocol or therapy within 28 days before screening (experimental peri-operative procedures such as the use of novel drains which are anticipated to affect the acute post-operative course, may be allowed after discussion with the medical monitor). 13 History of autoimmune disease (subjects with a history of resolved autoimmune thyroiditis may be eligible with consultation of the study medical monitor). 14 Known history of hypersensitivity to gemcitabine. 15. High risk for noncompliance with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of weekly followed by monthly doses of GI-4000 in combination with adjuvant gemcitabine versus adjuvant gemcitabine with placebo in post-resection pancreatic cancer patients, as measured by time to recurrence.;Secondary Objective: 1. To evaluate secondary endpoints of disease response as measured by the duration of recurrence-free survival, time to mortality, duration of overall survival, changes in symptom scores, and CA 19-9 levels. 2.To evaluate the immunogenicity of GI-4000, as measured by antigen specific T-cell responses. Genome wide association studies including full length genomic sequencing in a subset of subjects will also be applied to the current study to evaluate whether genetic determinants can influence immune response to blinded study therapy (GI-4000 versus placebo) as well as clinical outcomes such as time to disease recurrence and mortality. 3. To evaluate the safety of GI-4000 in a regimen combined with gemcitabine, as measured by SAEs, discontinuation due to AEs, and dosing interruptions/reductions due to AEs. ;Primary end point(s): Recurrence free survival at 15 months after randomization.;Timepoint(s) of evaluation of this end point: Duration of recurence free survival is number of days from randomization to the earlier date of disease progression or death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to mortality 2. Biochemical recurrence (CA19-9) 3. Duration of recurrence-free survival measured from the date of randomization 4. Duration of recurrence-free survival measured from the date of surgery 5. Duration of overall survival measured from the date of randomization 6. Duration of overall survival measured from the date of surgery 7. Longitudinal changes in CA 19-9 levels relative to the baseline level 8. Longitudinal changes in EORTC QLQ C30 symptom scores from baseline for nausea/vomiting, pain, and fatigue 9. Longitudinal changes in ECOG performance status scores from baseline ;Timepoint(s) of evaluation of this end point: 1. Time to mortality - from randomization to subject's death 2. Biochemical recurrence (CA19-9), Longitudinal changes in CA 19-9 levels relative to the baseline level, Longitudinal changes in EORTC QLQ C30 symptom scores, Longitudinal changes in ECOG performance status scores - from screening to disease progression 3. Duration of recurrence-free survival measured from the date of randomization, Duration of overall survival measured from the date of randomization - from randomization to disease progression or death 4. Duration of recurrence-free survival measured from the date of surgery, Duration of overall survival measured from the date of surgery - from the surgery to disease progression or death | — |
Countries
Bulgaria, India, United States
Contacts
Public ContactAlicia Mattson, RN BSN
GlobeImmune, Inc.
Outcome results
None listed