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Safety and efficacy of adding immunotherapy combined with stereotactic radiotherapy in patients with limited metastatic pancreatic cancer (MEPANC-1)
EU CTIS ID: 2024-514598-23-00
What this study is testing
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.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed (metastatic) pancreatic cancer, as indicated by a definite cytology/histology report.
- 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.
You likely can't join if
- Metastasis in other organs than the lung and liver.
- 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).
See the full eligibility criteria
- Histologically confirmed (metastatic) pancreatic cancer, as indicated by a definite cytology/histology report.
- 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.
- ≤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).
- Metastasis in other organs than the lung and liver.
- 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.
- Histopathologically proven extra regional lymph node metastasis.
- Malignant ascites.
- Liver function insufficient to tolerate the prescribed dose of radiotherapy. To be determined by the treating radiologist.
- Child-Pugh Classification grade B/C.
- Lung function insufficient to tolerate the prescribed dose of radiotherapy. To be determined by the treating radiologist.
- 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 3 years previously to diagnosis of pancreatic cancer and without evidence of recurrence.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.