Safety and efficacy of IMM-101 combined with stereotactic radiotherapy in patients with limited MEtastatic PANcreatic Cancer (MEPANC-1)

Phase 2

Recruiting

• Conditions: metastatic pancreatic cancer; pancreatic ductal adenocarcinoma; 10015674

• Registration Number: NL-OMON54853
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

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 <9 cm.
• The combined diameter of all pulmonary metastases is <9 cm.
• CA 19-9 < 1000 IU/mL after completion of chemotherapy.
• Age > 18 years and < 75 years.
• WHO performance status of 0-2
• Tumour volume of the primary tumour <7cmx7cmx7cm. Each diameter must not
exceed 7 cm.
• Adequate renal function (eGFR >= 30 ml/min).
• Adequate liver tests (bilirubin < 1.5 times normal; ALAT/ASAT < 5 times
normal).
• Adequate bone marrow function (WBC > 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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified