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Table 2 Selected inclusion and exclusion criteria

From: NIPU: a randomised, open-label, phase II study evaluating nivolumab and ipilimumab combined with UV1 vaccination as second line treatment in patients with malignant mesothelioma

Selected inclusion criteria Selected exclusion criteria
1. Histologically and/or cytologically confirmed MPM 1. Disease suitable for curative surgery
2. Unresectable disease, not candidate for curative surgery 2. Previous treatment with a PD1 or PD-L1 inhibitor
3. Measurable disease, defined as at least one lesion (CT or MRI) that is suitable for repeated assessment 3. Non-pleural mesothelioma e.g. mesothelioma arising in other organs
4. Available unstained archived tumour tissue sample 4. Active second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ
5. Previously treated with at least one line of platinum doublet 5. Symptomatic or uncontrolled brain metastases requiring concurrent treatment
6. ECOG performance status of 0–1 6. Known history of leptomeningeal carcinomatosis
7. Willing to provide archived tumour tissue and blood samples for research 7. Active or prior documented autoimmune or inflammatory disorders
8. Adequate organ function 8. History of primary immunodeficiency
9. Age ≥ 18 years 9. History of allogeneic organ transplant
  10. Uncontrolled intercurrent illness
  11. Active infection