A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer|
- No clinically relevant deleterious effect of IMM-101 on safety and tolerability. [ Time Frame: After 12 months or as clinically indicated ] [ Designated as safety issue: Yes ]
A clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles will be judged by:
- Local and systemic toxicities.
- Number, type and degree of toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.
- QoL (EORTC QLQ-C30 questionnaire supplemented by the pancreas cancer specific EORTC QLQ-PAN26 questionnaire).Efficacy will be defined as a clinically relevant improvement in one or more markers of disease status.
- A clinically relevant improvement in one or more markers of disease status [ Time Frame: 12 months or as clinically indicated ] [ Designated as safety issue: No ]
A clinically relevant improvement in one or more markers of disease status:
- Overall survival (OS).
- Progression-free survival (PFS).
- Overall response rate (ORR).
- Reduction in metastatic disease.
- Circulating levels of carbohydrate antigen 19.9 (CA19.9).
- Circulating levels of carcinoembryonic antigen (CEA).
- Nutritional status (weight, appetite, serum albumin).
- Pain control and analgesic use.
- Immunological markers [ Time Frame: 12 months or as clinically indicated ] [ Designated as safety issue: No ]
Blood samples will be collected from all patients for analysis of immunological markers and mediators (e.g. cytokines and antibodies, any other immunologically relevant assays.
For a subset of patients cells will be isolated from the whole blood samples. Exploratory endpoints may include:
- A change in levels of circulating tumour cells (CTCs)
- A change in one or more markers of immune status
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Active Comparator: gemcitabine chemotherapy
Patients in the control arm will receive normal standard of care - up to 12 cycles of Gemcitabine. Dosing of Gemcitabine is as per the normal orescribing information for pancreatic cancer.
Gemcitabine will be administered intravenously at 1000 mg/m2 over 30 minutes once weekly for 3 consecutive weeks out of every 4 weeks.
Chemotherapy will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles (i.e. approximately 48 weeks).
Dosage reduction with each cycle or within each cycle may be applied based upon the grade of Gemcitabine-related toxicity experienced by the patient using centre's standard protocol.
Other Name: Gemzar
Experimental: IMM-101 in addition to gemcitabine
Patients in the experiemental arm will recieve IMM-101 in addition the current standard of care, namely chemotherapy (Gemcitabine). The treatment regimen with IMM-101 will be every 2 weeks for the first 3 doses followed by a rest of 4 weeks then every 2 weeks for the next 3 doses followed by every 4 weeks thereafter.
For patients in the active group, chemotherapy (GEM) will begin at least 14 days after first dose of IMM-101.
Chemotherapy plus IMM-101 will be offered until intolerable toxcity or withdrawal from the study up to a maximum of 12 cycles (i.e. approximately 48 weeks).
IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
A single 0.1 mL intradermal injection of IMM-101 (10 mg/mL)will be administered every 2 weeks for the first 3 doses followed by a rest of 4 weeks then every 2 weeks for the next 3 doses followed by every 4 weeks thereafter.
Chemotherapy plus IMM-101 will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles of gemcitabine.
Other Name: Heat killed whole cell Mycobacterium obuense, M. obuense
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303172
|Cyprus Oncology Centre|
|Nicosia, Strovolos, Cyprus, 2006|
|Adelaide, Meath & National Childrens Hospital,|
|Dublin, Ireland, Dublin 24|
|St Vicents University Hospital|
|Dublin, Ireland, Dublin 4|
|A.O. Santa Croce e Carle, Struttura Complessa di Oncologia Medica|
|Confreria, Cuneo, Italy|
|Azienda Ospedaliero-Universitaria di Bologna|
|Bologna, Italy, 40138|
|Azienda Ospedaliera San Gerardo Struttura Complessa Oncologia Medica|
|Monza, Italy, 20052|
|AOU Maggiore della Carità|
|Medical Oncology Department, Central University Hospital of Asturias|
|Asturias, Oviedo, Spain|
|Hospital General de Alicante|
|Alicante, Spain, 03010|
|Hospital Gregorio Marañon|
|Madrid, Spain, 28007|
|Department of Medical Oncology, Hospital Universitari La Fe,|
|Instituto Valenciano de Oncologia|
|Valencia, Spain, 46009|
|Hospital Miguel Servet|
|Zaragoza, Spain, 50009|
|Airedale General Hospital|
|Skipton, West Yorkshire, United Kingdom, BD20 6TD|
|Royal Blackburn Hospital|
|Blackburn, United Kingdom, BB2 3HH|
|Bradford Royal Infirmary|
|Bradford, United Kingdom, BD9 6RJ|
|Velindre Cancer Centre|
|Cardiff, United Kingdom, Velindre Cancer Centre|
|Dundee, United Kingdom, DD1 9SY|
|Mount Vernon Cancer Centre|
|London, United Kingdom, HA6 2RN|
|The London Clinic Cancer Centre|
|London, United Kingdom, W1G 6BW|
|Peterbrough City Hospital, Haematology/Oncology Dept,|
|Peterborough, United Kingdom, PE3 9GZ|
|Principal Investigator:||Angus Dalgleish, Professor||St George's, University of London|