Limited metastatic pancreatic cancer MedDRA version: 27.0 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: IMM-101
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: MYCOBACTERIUM OBUENSE
Current Sponsor code: IMM-101
Other descriptive name: MYCOBACTERIUM OBUENSE
Concentration
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed (metastatic) pancreatic cancer, as indicated by a definite cytology/histology report. • =5 hepatic and/or pulmonary metastases in total. • The combined diameter of all liver metastases AND the primary tumour or local recurrence in the pancreas is 18 years and 3.0 x 109/L, platelets > 100 x 109/L and hemoglobin > 5.6 mmol/l). • Effective contraceptive methods. • Written informed consent. • Patients who did not complete at least 8 cycles of FOLFIRINOX due to severe toxicity, will be included in the expansion cohort. 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Metastasis in other organs than the lung and liver. • Histopathologically proven extra regional lymph node metastasis. • Malignant ascites. • Liver function insufficient to tolerate the prescribed dose of radiotherapy.* • Child-Pugh Classification grade B/C. • Lung function insufficient to tolerate the prescribed dose of radiotherapy.* • Diffuse liver metastasis pattern on CT scan. • Current or previous treatment with immunotherapeutic drugs. • Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 5 years previously to diagnosis of pancreatic cancer and without evidence of recurrence. • Pregnancy, breast feeding. • An active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or other immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the planned first dose of the study. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor. • History of Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies). • Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). • Positive PCR test for presence of SARS-CoV-2 during screening stage. • Live virus vaccine within 30 days of planned start of trial treatment. • Use of herbal remedies, including traditional Chinese herbal products (e.g., mistletoe). • Allergic reaction to M. obuense or had previously received IMM-101. • Otherwise deemed unsuitable by the Investigator. *To be determined by the treating radiologist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is an open-label, non-randomized, multicentre phase II study with an initial safety-run in. During the safety run-in phase, we will investigate the safety of combining IMM-101 administration with SBRT in 20 patients with limited metastatic disease in the liver and/or lung. If deemed safe, we will continue inclusion in the second phase of the study with an additional 80 patients in order to evaluate the efficacy of combining IMM-101 treatment with SBRT based on a 100% improvement of progression free survival. The primary objective of the safety run-in is to determine safety of IMM-101 combined with SBRT in patients with limited metastatic pancreatic cancer. When this combination is found to be safe, the second phase of the study will be initiated, the primary objective of the phase II is to investigate the potential efficacy of IMM-101 combined with SBRT. ;Secondary Objective: • Overall survival calculated from the start of FOLFIRINOX (OS1). • Overall survival calculated from start of IMM-101 (OS2). • Progression-free survival calculated from the start of IMM-101 (PFS 2) at 12-month to the date of progressive disease of the primary tumour, locoregional recurrence, progression of previously treated lungs and/or liver metastases, the occurrence of new metastases, or death. All included patients will be analysed for this endpoint. • Quality of Life. • Radiological response rate after IMM-101 and SBRT using iRECIST criteria. • Radiological response rate after IMM-101 and SBRT using RECIST criteria (version 1.1). • Immunological effects: effect of IMM-101 and SBRT on circulating immune cells. • Effect on tumour markers, CA19.9 and CEA. ;Primary end point(s): Safety run-in The main goal of this study is to determine safety of IMM-101 and SBRT in patients with limited metastatic disease in the lung and/or liver from PDAC. The toxicity of IMM-101 and SBRT is defined according to Common Terminology Criteria for Adverse Events (CTCAE version 5). Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival calculated from the start of FOLFIRINOX (OS1). • Overall survival calculated from start of IMM-101 (OS2). • Progression-free survival calculated from the start of IMM-101 (PFS 2) at 12-month to the date of progressive disease of the primary tumour, locoregional recurrence, progression of previously treated lungs and/or liver metastases, the occurrence of new metastases, or death. All included patients will be analysed for this endpoint. • Quality of Life. • Radiological response rate after IMM-101 and SBRT using iRECIST criteria. • Radiological response rate after IMM-101 and SBRT using RECIST criteria (version 1.1). Details about the RECIST criteria are shown in Appendix A. • Determining immune responses as described in section 8.3.6. • Effect on tumour markers: pre- and 2x post-treatment CA19.9 and CEA levels will be assessed on blood samples. ;Timepoint(s) of evaluation of this end point: LPLV | — |
Countries
Netherlands
Contacts
Public Contactresearch coordinator
Erasmus MC
Outcome results
None listed