DOCETAXEL for Metastatic squamous cell carcinoma of the anus

Inclusion criteria

• {"criterion_text":"- 1.\tMale or female, aged ≥18 years,\n- 10.\tSigned and dated informed consent, to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study\n- 11.\tPatient affiliated to or beneficiary of French social security system\n- 12.\tAbility to comply with the study protocol, in the Investigator’s judgment\n- 2.\tPerformance status Eastern Cooperative Oncology Group World Health Organization (ECOG-WHO) ≤1,\n- 3.\tHistologically proven metastatic or locally advanced recurrent squamous cell carcinoma of anus (SCCA)Presence of a evaluable lesion on CT-scan/MRI assessed by RECIST v1.1 criteria,\n- 4.\tPatient eligible to the mDCF regimen\n- 5.\tNo previous systemic (immunotherapy or chemotherapy) treatment.\n- 6.\tCT scan performed within 30 days prior inclusion,\n- 7.\tPET scan performed within 30 days prior inclusion\n- 8.\tLife expectancy ≥12 months,\n- 9.\tAdequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment: a.\tAbsolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L) without granulocyte colony-stimulating factor support. b.\tWhite blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L). c.\tPlatelets ≥ 100,000/mm3 (≥ 100 GI/L) without transfusion. d.\tHemoglobin ≥ 9 g/dL (≥ 90 g/L). e.\tAlanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN), or ≤ 5 x ULN with documented liver metastases. f.\tTotal bilirubin ≤ 1.5 x ULN (for subjects with Gilbert’s disease ≤ 3 x ULN). g.\tSerum albumin ≥ 2.8 g/dl. h.\tCalculated creatinine clearance ≥ 60 mL/min (using the MDRD formula): i.\tUrine protein/creatinine ratio (UPCR) ≤ 1 g/g"}

Exclusion criteria

• {"criterion_text":"- 1.\tHIV positive patient , CD4 count < 400 cells/mm3 (HIV test mandatory before inclusion)\n- 10.\tUntreated or symptomatic central nervous system (CNS) lesion. However, patients are eligible if: a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease progression ≥ 4 weeks after treatment and c) patients must be off corticosteroid therapy for ≥ 2 weeks\n- 11.\tUse of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GMCSF, M-CSF), thrombopoietin mimetics or erythroid stimulating agents ≤ 2 weeks prior start of study treatment. If erythroid stimulating agents were initiated more than 2 weeks prior to the first dose of study treatment and the patient is on a stable dose, they can be maintained.\n- 12.\tUse of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment\n- 13.\tElevated Cardiac troponin T (cTnT) or cardiac troponin I (cTnI) elevation > 2x ULN\n- 14.\tSystemic chronic steroid therapy (> 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment. Note: Topical, inhaled, nasal and ophthalmic steroids are allowed. For patients with adrenal insufficiency, replacement dose of prednisone > 10 mg/ day or equivalent are permitted\n- 15.\tActive, known or suspected autoimmune disease or a documented history of autoimmune disease Note: Patients with vitiligo, controlled type I diabetes mellitus on stable insulin dose, residual autoimmune-related hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted.\n- 16.\tAllogenic bone marrow or solid organ transplant\n- 17.\tHistory of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction\n- 18.\tPre-existing neuropathy, hearing problem, or cardiorespiratory pathology, which prevent the administration of cisplatin.\n- 19.\tclinically significant active heart disease or myocardial infarction within 6 months\n- 2.\tDiagnosis of additional malignancy within 2 years prior to the inclusion with the exception for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy,\n- 20.\trecent or concomitant treatment with brivudine\n- 21.\tpersistent toxicities related to prior treatment of grade greater than 1\n- 22.\tHistory or current interstitial lung disease or non-infectious pneumonitis\n- 23.\tHistory of major surgery within 28 days before treatment\n- 24.\tActive infection\n- 25.\tActive Hepatitis B infection (HBsAg positive)\n- 26.\tActive hepatitis C (HCV RNA positive)\n- 27.\tPregnant or nursing (lactating) women confirmed by a positive hCG laboratory test within 72 hours prior to initiating study treatment. Note: Low levels of hCG may also be considered a tumor marker, therefore if low hCG levels are detected, another blood sample at least 4 days later must be taken to assess the kinetics of the increase and transvaginal ultrasound must be performed to rule out pregnancy.\n- 28.\tWomen of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7.5 months after stopping treatment with Spartalizumab.\n- 29.\tComplete or partial deficit in dihydropyrimidine dehydrogenase (DPD) activity\n- 3.\tAny medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study,\n- 30.\tActive inflammatory bowel disease\n- 4.\t\tCurrent participation in a study of an investigational agent or in the period of exclusion,\n- 5.\t\tReceipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment,\n- 6.\t\tRadiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible,\n- 7.\t\tPregnancy, breast-feeding or absence/refusal of adequate contraception for fertile patients during the period of treatment and for 7.5 months in women and 4.5 months in men from the last treatment administration,\n- 8.\t\tPatient under guardianship, curatorship or under the protection of justice.\n- 9.\tInability to perform radiotherapy"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the Progression Free Survival (PFS) rate at 1 year evaluated by RECIST criteria v1.1. PFS rate at 1 year is defined as the number of patients alive without progression at 1 year divided by the overall number of patients evaluable for PFS status at 1 year.","definition_or_measurement_approach":"PFS rate at 1 year is defined as the number of patients alive without progression at 1 year divided by the overall number of patients evaluable for PFS status at 1 year, evaluated by RECIST v1.1."}

France

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

22-08-2024

Processing Time Days

23

Number Of Sites

5

Number Of Participants

34

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France