A MULTICENTER, SEEKING SIGNAL, RANDOMISED, OPEN-LABEL PHASE II OF RELATLIMAB AND NIVOLUMAB VS NIVOLUMAB ALONE IN LOCALLY ADVANCED CERVICAL CANCERS

Multicenter, open-label, randomized, seeking signal (non-comparative), Phase II aiming to assess the clinical activity of the combination relatlimab + nivolumab in locally advanced cervical cancer eligible to standard CCRT

Inclusion Criteria: * Female patients aged ≥18 years at time of inform consent signature. * Patients must have histologically confirmed diagnosis of cervical squamous or adenosquamous carcinoma stage IIB to IVA according to FIGO 2018 (Appendix 1) and no evidence of metastatic disease (M0). Note: Nodal staging may be either surgical or by imaging (MRI/PET-CT) with pathological lymph node size defined by a short-axis diameter of ≥10mm (axial plane) or FDG uptake greater than that of the surrounding tissue and corresponding to the LN structure on CT when CT was performed for PETCT analysis. * Patients must be naïve from prior anti-cancer treatment (all type) and eligible to standard CCRT as per standard practice and investigator' judgement. * Known HPV status as per local assessment. * Patient accepting to undergo a new cervix biopsy and with at least one lesion with a diameter ≥10 mm, visible by medical imaging and accessible to percutaneous sampling (needle biopsies 16 gauge or larger) that permit core needle biopsy (ideally 4 cores) without unacceptable risk of a major procedural complication. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix 2). * Adequate organ and marrow function with following lab values within 7 days before C1D1: * Absolute neutrophil count (ANC) ≥1500/μL * White blood cell (WBC) \>3000/μL * Platelets ≥100 000/μL * Hemoglobin (Hb) ≥9 g/dL * Total bilirubin ≤1.5× upper limit of normal (ULN) unless due to Gilbert's syndrome * ASAT /ALAT ≤3 ULN * Creatinine ≤1.5 within normal limit, or * Creatinine clearance ≥ 40 mL/min according to CKD-EPI formula (Appendix 3) * Troponin T or I \< 2 x ULN * Adequate cardiovascular function documented by: * QTc interval \ 50% based on screening echocardiogram (ECHO) or multigated acquisition scan (MUGA). * Controlled blood pressure (BP, \