Clinical trial NCT03132038 (phase 2, status: active, not recruiting)
Conditions: salivary gland carcinoma, metastatic cancer, recurrent cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
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:

          -  Adult men and women ≥18 years

          -  Histologically confirmed carcinoma of the salivary glands, recurrent or metastatic
             (adenoid cystic carcinoma or non-adenoid cystic carcinoma) not eligible to local
             treatment

          -  Pre-treatment tumor tissue available for central review and biomarkers analysis.

          -  At least one measurable lesion ≥10 mm (outside any previous irradiated field)
             according to RECIST v1.1 with magnetic resonance imaging (MRI) or computed tomography
             (CT)-scan

          -  Patients with confirmed disease progression at study entry. The "baseline"
             radiological evaluation (either MRI or CT scan) should demonstrate disease progression
             by RECIST 1.1 when compared to a prior disease assessment done within a 6 months
             period prior to screening

          -  Previous anti-cancer therapies must be discontinued at least 4 weeks prior to
             administration of study drug. Concomitant, palliative (limited-field) radiation
             therapy is permitted during the study, if all of the following criteria are met: (1)
             repeated imaging demonstrates no new sites of bone metastases ; (2) The lesion being
             considered for palliative radiation is not a target lesion

          -  Performance status Eastern Cooperative Oncology Group (ECOG) <2

          -  Screening laboratory values must meet the following criteria and should be obtained
             within 7 days prior to starting study drug: White Blood Cell (WBC) ≥2000/mm³,
             Neutrophils ≥1500/mm³, Platelets ≥100 000 /mm³, Hemoglobin >9.0 g/dL, Serum creatinine
             ≤1.5 x Upper Limit of Normal (ULN) or creatinine clearance (CrCl) ≥40 mL/min (using
             the Cockcroft-Gault formula), aspartate transaminase (AST) / alanine transaminase
             (ALT) / alkaline phosphatase (PAL) ≤3 x ULN or ≤5 x ULN when liver metastases, Total
             Bilirubin ≤1.5 x ULN (except subjects with Gilbert Syndrome, who can have total
             bilirubin <3.0 mg/dL)

          -  Women of childbearing potential (WOCBP) must use appropriate method(s) of
             contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30
             days plus the time required for nivolumab to undergo five half-lives) 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
             start of nivolumab

          -  Women who are breastfeeding should discontinue nursing prior to the first dose of
             study drug and until 6 months after the last dose

          -  Men who are sexually active with WOCBP must use any contraceptive method with a
             failure rate of less than 1% per year. Men receiving nivolumab and who are sexually
             active with WOCBP will be instructed to adhere to contraception for a period of 31
             weeks after the last dose of investigational product. Women who are not of
             childbearing potential (ie, who are postmenopausal or surgically sterile as well as
             azoospermic men do not require contraception)

          -  Provision of signed and dated, written informed consent prior to any study specific
             procedures, sampling and analyses

          -  Patients with social insurance coverage

        Exclusion Criteria:

          -  Stable disease

          -  Symptomatic / active brain metastases

          -  Immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone
             equivalents) within 2 weeks prior to study drug administration. A 2 weeks wash-out
             minimum is required before starting study drug

          -  Patients with a condition requiring systemic treatment with either corticosteroids
             (>10 mg daily prednisone equivalents) or other immunosuppressive 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 with any active or suspected autoimmune disease or an history of known
             autoimmune disease (Patients with vitiligo, type I diabetes mellitus, residual
             hypothyroidism due to an autoimmune condition only requiring hormone replacement,
             psoriasis not requiring systemic treatment, or conditions not expected to recur in the
             absence of an external trigger are however eligible for this trial)

          -  Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,
             anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically
             targeting T-cell co-stimulation or checkpoint pathways)

          -  History of organ transplantation requiring long-term immunosuppressive medications

          -  Known history of testing positive for human immunodeficiency virus (HIV) or known
             acquired immunodeficiency syndrome (AIDS)

          -  Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus
             ribonucleic acid (HCV antibody) indicating acute or chronic infection

          -  Known history or active tuberculosis

          -  Any other malignancy (except for appropriately treated superficial basal cell skin
             cancer and surgically cured in situ cancer) unless free of disease for at least three
             years

          -  History of allergy to study drug components

          -  Any toxicity (other than alopecia) attributed to prior anti-cancer therapy not
             resolved to grade 1 (NCI CTCAE version 4) at baseline level before administration of
             study drug.

          -  Known or underlying medical condition (e.g., a condition associated with diarrhea or
             acute diverticulitis) that, in the investigator's opinion, would make the
             administration of study drug hazardous to the patient or obscure the interpretation of
             toxicity determination or adverse events

          -  History of uncontrolled seizures, central nervous system disorders or psychiatric
             disability judged by the investigator to be clinically significant, precluding
             informed consent, or interfering with compliance of oral drug intake (if applicable)

          -  Unwillingness to give written informed consent, unwillingness to participate, or
             inability to comply with the protocol for the duration of the study

          -  Individuals deprived of liberty or placed under the authority of a tutor

          -  Treatment with any other investigational agent, or participation in another clinical
             trial within 28 days prior to enrolment and during the treatment period