limited metastatic pancreatic cancer
Conditions
Interventions
IMM-101 immunotherapy and stereotactic radiotherapy (SBRT)
Sponsors
Erasmus MC
Eligibility
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 chemotherapy due to severe toxicity, will be included in the expansion cohort.
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 |
|---|---|
| The main goal of the safety run-in is to determine the safety/toxicity profile of IMM-101 vaccination in combination with SBRT in patients with limited meta- or synchronous metastatic disease liver and/or lung metastatic disease from pancreatic cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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 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. | — |
Contacts
Public ContactJudith Verhagen
Erasmus MC
Outcome results
None listed