Safety and efficacy of the addition of IMM-101 Heat-Killed Whole Cell Mycobacterium obuense to standard stereotactic radiotherapy in locally advanced pancreatic cancer patients (LAPC-2 trial).

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 38

Inclusion Criteria

• Histologically confirmed pancreatic cancer, as indicated by a definite
cytology report
• Tumor considered locally advanced after diagnostic work-up including
CT-imaging and diagnostic laparoscopy.
• Age > 18 years and < 75 years.
• WHO performance status of 0 or 1.
• ASA classification I or II.
• No evidence of metastatic disease.
• Largest tumor diameter < 7 cm x 7 cm x 7 cm.
• No direct tumor involvement oft he stomach, colon or small bowel.
• Normal renal function (Creatinine >= 30 ml/min).
• Normal liver tests (bilirubin < 1.5 times normal; ALAT/ASAT < 5 times normal).
• Normal bone marrow function (WBC > 3.0 x 10e9/L, platelets > 100 x 10e9/L and
hemoglobin > 5.6 mmol/l).
• Ability to wear and Actiwatch device on non-dominant arm
• Written informed consent.

Exclusion Criteria

• Previous allergic reaction to any mycobacterial product
• Prolonged systemic corticosteroid or immunosuppressant medication use
• Pregnancy
• Lymph node metastases from primary tumor outside the field of radiation.
• Second primary malignancy except in situ carcinoma of the cervix, adequately
treated non-melanoma skin cancer, or other malignancy treated at least 3 years
previously without evidence of recurrence.
• Pregnancy, breast feeding.
• Serious concomitant systemic disorders that would compromise the safety of
the patient or his/her ability to complete the study, at the discretion of the
investigator.
• An active autoimmune disease that has required systemic treatment in past 2
years (i.e. with use of disease modifying agents, corticosteroids or
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.
• Known history of Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies).
• Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
[qualitative] is detected).
• Live virus vaccine within 30 days of planned start of trial treatment.
• Use of herbal remedies, including traditional Chinese herbal products (e.g.,
mistletoe).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For the first phase of 20 patients, safety defined as max 6 out of 20 patients<br /><br>experiencing a grade 4/5 toxicity related to the IMM-101 intervention, will be<br /><br>the main endpoint. Safety evaluation will take place after the 20th patients<br /><br>has received the 3rd vaccination. For the overall study efficacy, defined as an<br /><br>increase of 20% in 1-year progression free survival, will be the main endpoint. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints for the overall study will be overall survival, time to<br /><br>locoregional progression, time to distant metastasis, safety/toxicity,<br /><br>feasibility, resection rate, immune responses and quality of life/sleep.</p><br>