Clinical trial NCT02497508 (phase 2, status: completed)
Conditions: malignant pleural mesothelioma
ICD codes: C45.9, C45.0, C45.1, C45.2, C45.7
Drugs: nivolumab
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histological or cytological diagnosed malignant pleural mesothelioma and
             age >18 years.

          -  Progressive disease after at least one course of chemotherapy.

          -  Previous chemotherapy or experimental therapy ≥ 4 weeks ago.

          -  Medically suitable for limited surgical intervention (pleural biopsies up to limited
             pleurectomy).

          -  Not considered candidates for trimodality treatment (as part of a study).

          -  Measurable or evaluable disease (see tumor response assessment).

          -  Ability to understand the study and give signed informed consent prior to beginning of
             protocol specific procedures including the approval of a second thoracoscopy or
             transthoracic pleural biopsy after the third course.

          -  Radiotherapy is allowed when this is given for palliation, the interval is > 12 weeks
             and not all tumor is within the irradiation field.

          -  WHO performance status 0 or 1 (see appendix 1).

          -  Adequate organ function as evidenced by the following peripheral blood counts or serum
             chemistries at study entry:

               -  Hematology: Neutrophil count >= 1.5 x 109/l, Platelets >= 150 x 109/l, Hemoglobin
                  >= 6,0 mmol/l.

               -  Chemistry: Total serum bilirubin ≤ 1.5 times within the upper limits of normal
                  (ULN); ASAT and ALAT <= 2.5x ULN, AP (alkaline phosphatases) < 5x ULN (unless
                  bone metastases are present in the absence of any liver disease).

        Age and Reproductive Status

          -  Women of childbearing potential (WOCBP) must use appropriate method(s) of
             contraception to avoid pregnancy during treatment and for 23 weeks after the last dose
             of investigational drug.

          -  Women of childbearing potential must have a negative serum or urine pregnancy test
             (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the
             first dose of nivolumab.

          -  Men who are sexually active with WOCBP must use any contraceptive method with a
             failure rate of less than 1% per year during treatment and for a period of 31 weeks
             after the last dose of investigational drug.

          -  Women who are not of childbearing potential (ie, who are postmenopausal or surgically
             sterile) as well as azoospermic men do not require contraception.

        Exclusion Criteria:

          -  Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding
             tendency.

          -  Inability to perform biopsies of the pleural lesions.

          -  Symptomatic peripheral neuropathy >= grade 2 according to NCI CTC, version 4.0.

          -  Presence of symptomatic CNS metastases.

          -  Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling
             condition.

          -  Impaired renal function: creatinine clearance less than 50ml/min.

          -  Concomitant administration to any other experimental drugs under investigation.

          -  Patients are excluded if they have an active, known or suspected autoimmune disease.
             Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus,
             residual hypothyroidism due to autoimmune condition only requiring hormone
             replacement, psoriasis not requiring systemic treatment, or conditions not expected to
             recur in the absence of an external trigger

          -  Patients are excluded if they have a condition requiring systemic treatment with
             either corticosteroids (> 10 mg daily prednisone equivalents) or other
             immuno-suppressive medications within 14 days of study drug administration. Inhaled or
             topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents
             are permitted in the absence of active autoimmune disease.

          -  Patients are excluded if they have had prior treatment with an anti-PD-1, anti-PD-L1,
             anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting
             T-cell co-stimulation or immune checkpoint pathways