Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types

Inclusion Criteria

• •1. Patient information sheet and written informed consent form signed.
• •2. Histologically confirmed diagnosis of a pathology corresponding to one of the following selected cancer types:
• •* Non-clear cell renal-cell carcinomas: papillary renal cell carcinoma (pRCC, type I, type II and non-classified pRCC), chromophobe RCC (ChRCC), renal medullary carcinoma (RMC), collecting duct/Bellini duct carcinoma (CDC), microphthalmia-associated transcription (MiT) family translocation renal cell carcinoma (tRCC), renal cell carcinoma with a prominent sarcomatoid component (sarcRCC).From the 51st patient included in this cohort, only the following histological type will be selected: collecting duct/Bellini duct carcinoma (CDC).
• •* Rare head and neck cancers: principal and accessory salivary gland tumours, facial tissue tumours.
• •* Rare skin cancers: adnexal carcinomas, basal cell carcinoma resistant to vismodegib.From the 51st patient included in this cohort, only the following histological type will be selected: Basal Cell carcinoma.
• •* Non-colorectal cancers with microsatellite instability determined locally by immunohistochemistry or polymerase chain-reaction (PCR)
• •* Squamous cell carcinoma of penis.
• •* Any non MSI-high cancer with POLE exonucleasic domain mutation (somatic or germline) in hotspots (codons 286, 411, 424 and 459) or other germline or somatic variants with high probability of pathogenesis according to in silico assessment by the INCa ad hoc biology group.
• •3. Metastatic disease or unresectable locally advanced malignancy that is resistant or refractory to standard therapy or for which standard therapy does not exist or is not considered appropriate by the Investigator.
• •4. Aged ≥18 years old.
• •5. Measurable disease according to RECIST v1.1 guidelines for solid tumours.
• •6. Able to provide a formalin fixed/paraffin embedded (FFPE) biopsy sample of a metastatic site or primitive tumour tissue.
• •Note: Patients for whom suitable archived biopsy material is not available must be willing to undergo a biopsy of a tumour lesion prior to study entry, unless this is medically contraindicated (e.g. site inaccessible or patient safety concerns).
• •7. Patients must have a mandatory treatment-free interval of at least 21 days following previous systemic anti-cancer treatments.
• •8. Patients who have received previous systemic anticancer treatment and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 (according to NCI-CTCAE criteria, v 4.0) with the exception of Grade 2 alopecia.
• •9. Adequate hematologic function (absolute neutrophil count (ANC) ≥1.0 x10⁹/L, platelets ≥100 x10⁹/L, haemoglobin (Hb) ≥9 g/L) measured within 14 days of treatment initiation.
• •10. Adequate renal function (creatinine clearance ≥50 mL/min using the glomerular filtration rate (MDRD) or CKI EPI method) measured within 14 days of treatment initiation.
• •11. Adequate hepatic function (serum bilirubin ≤1.5 x the reference upper limit of normal (ULN) unless due to Gilbert's syndrome; aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤2.5 x ULN) measured within 14 days of treatment initiation. For patients with documented liver metastasis ASAT/ALAT ≤5 x ULN is acceptable.
• •12. Strictly normal blood levels of calcium and magnesium, measured within 14 days of treatment initiation.
• •13. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤1.
• •14. Estimated life expectancy ≥90 days.
• •15. Patients who are sexually active must agree to use a medically accepted method of contraception (e.g. implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner, for participating women; condoms for participating men) or practice complete abstinence, beginning 14 days before the first administration of investigational product (IP), while on treatment and for at least 5 months after the last administration of IP for female patients, and 7 months after the last administration of IP for male patients.
• •16. Women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to the first administration of IP. If urine test results are positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• •17. Women who are breastfeeding should discontinue nursing prior to the first administration of IP and for at least 90 days after the last administration of IP.
• •18. Patients must be affiliated to a Social Security System or equivalent.