Clinical trial NCT03013335 (phase 2, status: active, not recruiting)
Conditions: metastatic renal cell carcinoma
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
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:

          1. Adult men and women ≥18 years.

          2. Patients with a histologically confirmed Renal Cell Carcinoma with a clear-cell
             component.

          3. Patients with metastatic (AJCC stage IV) Renal Cell Carcinoma, with at least one
             measurable lesion by CT Scan or MRI according to RECIST 1.1 or with clinically
             apparent disease that can be reliably monitored by the investigator.

          4. Patients having received at least one prior systemic anti-angiogenic treatment
             including but not limited to: sunitinib, sorafenib, pazopanib, axitinib, and
             bevacizumab, in the advanced or metastatic setting. Prior cytokine therapies (e.g.
             IL-2, IFN-α), vaccine therapy or treatment with cytotoxics are allowed. Patients
             intolerant to prior systemic anti-angiogenic treatment can also be eligible (except
             hypersensitivity to other monoclonal antibodies). A maximum of 25% of patients with
             more than 2 prior systemic treatments will be recruited per sites.

          5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

          6. Favorable, intermediate or poor risk group patients measured by the international
             metastatic renal cell carcinoma database consortium (IMDC) model.

          7. Patients with brain metastases will be eligible if they are: asymptomatic, without
             edema, not on corticosteroids, not be eligible for radiation therapy/surgery and not
             receiving active treatments.

          8. Patients who have progressed following radiation therapy. Palliative, focal radiation
             therapy, and immunosuppressive doses of systemic corticosteroids, except replacement
             organotherapy (hydrocortisone and fludrocortisone), must be discontinued at least 2
             weeks prior to the first nivolumab administration.

          9. Potentially reproductive patients must agree to use an effective contraceptive method
             or practice adequate methods of birth control or practice complete abstinence while on
             treatment, and for at least 31 weeks (≈ 7 months) for males and 23 weeks (≈ 5 months)
             for females after the last dose of study drug. Azoospermic males and women of
             childbearing potential who are continuously not heterosexually active are exempt from
             contraceptive requirements.

         10. Women of childbearing potential must have a negative serum pregnancy test done within
             24 hours prior to the first dosing.

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

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

         13. Patients with social insurance coverage.

        Exclusion Criteria:

          1. Patients with any active autoimmune disease or a history of known autoimmune disease
             (Patients with type I diabetes mellitus, residual hypothyroidism due to an autoimmune
             condition 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).

          2. Patients with uncontrolled adrenal insufficiency.

          3. Patients with known history of testing positive for human immunodeficiency virus (HIV)
             or known acquired immunodeficiency syndrome (AIDS).

          4. Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or
             hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.

          5. 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).

          6. Patients having received any non-oncology vaccine therapy used for prevention of
             infectious diseases including seasonal (influenza) vaccinations within 4 weeks of the
             first dose of study drug.

          7. Patients receiving anti-cancer therapies must be discontinued at least 2 weeks prior
             to administration of study drug. Palliative, focal radiation therapy, and
             immunosuppressive doses of systemic corticosteroids, except replacement organotherapy
             (hydrocortisone and fludrocortisone), must be discontinued at least 2 weeks before
             administration of study drug. All toxicities attributed to prior anti-cancer therapy
             other than alopecia must have resolved to grade 1 (NCI-CTCAE version 4) or baseline
             before administration of study drug.

          8. Patients with other prior malignancy active within the previous 3 years except for
             locally curable cancers that have been apparently cured, such as basal or squamous
             cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate,
             cervix or breast.

          9. Patients with altered hematopoietic or organ function, as indicated by the following
             criteria (assessed within 14 days prior the first dosing):

               -  White blood cell count <2000/µL

               -  Polynuclear neutrophils <1.5 x 10⁹/L

               -  Platelets <100 x 10⁹/L

               -  Hemoglobin <8.0 g/mL

               -  Alanine aminotransferase (ALAT)/ aspartate aminotransferase (ASAT) >3.0 x upper
                  limit of normal (ULN) in the absence of liver metastases or >5 x ULN in the
                  presence of liver metastases

               -  Bilirubin >1.5 x ULN (except Gilbert Syndrome: <3.0 mg/dL)

               -  Creatinine clearance ≤40 mL/min (measured or calculated by Cockcroft and Gault
                  formula) or serum creatinine >2.0 x ULN

         10. Patients with a history of hypersensitivity to other monoclonal antibodies or to the
             active or inactive excipients of study drug.

         11. Known drug or alcohol abuse.

         12. 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.

         13. 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.

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

         15. Individuals deprived of liberty or placed under the authority of a tutor.

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