NIVOLUMAB for Nasopharyngeal cancer

Inclusion criteria

• {"criterion_text":"- Age > 18 years old\n- Histological or cytological documentation of squamous cell carcinoma\n- Primary tumor location in nasopharynx\n- Previous, documented failure on platinum-based chemotherapy or progression of the disease during platinum-based chemotherapy\n- Tumor reccurence (local or nodal) or generalization (metastasis) occurence during or within 6 months after previous platinum-based chemotherapy\n- ECOG performance scale 0-1\n- Participant is willing and able to give informed consent for participation in the study and agrees to undergo all follow up visit and planned procedures."}

Exclusion criteria

• {"criterion_text":"- Known active central nervous system metastases\n- Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent\n- Patient is currently participating in another clinical trial.\n- Active infection, which significantly affects the patient's clinical condition and requires treatment.\n- Patient with prior bone marrow or solid organ transplantation.\n- Patient requires immunosuppressive agents, including steroids (daily dose of prednisone or equivalent > 10 mg)\n- Known immunodeficiency including HIV/AIDS infection.\n- Patient received any live vaccine within 28 days before enrollment.\n- Heart Failure - NYHA III or IV\n- Coexistence of active malignant tumor or history of malignant tumor after radical treatment with disease-free period > 2 years, except: cervical cancer in situ/ basocellular skin cancer/prostate cancer, after radical treatment.\n- Other comorbidities symptoms or conditions that in Investigator's judgement prevent patient from participation in clinical trial.\n- Presence of renal insufficiency defined as eGFR < 30 ml/min/m2\n- Presence of liver disfunction, defined as level of AST and /or ALT > 2,5 x ULN (> 5 x ULN in patients with documented liver metastases); total bilirubin > 1,5 x ULN ( bilirubin > 1,5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%) or albumin < 2,5 g/dL\n- Abnormalities in blood count such as: hemoglobin < 9 g/dl, platelets < 100 x 109 /L, Absolute Neutrophil Count (ANC) <1,0 x 109 /L\n- Ejection fraction in echocardiography < 50%\n- History of active autoimmune diseases except for type I diabetes, hypothyroidism (treated only with hormone supplementation), psoriasis, albinism.\n- Patient with diagnosed mental disorder preventing, in Investigator's opinion, from participating in a clinical trial.\n- Pregnancy or breastfeeding.\n- Female with childbearing potential or male participant with female partner of childbearing potential, who is unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the entire clinical trial period and for 5 months after the end of treatment (last infusion)"}

Primary endpoints

• {"endpoint_text":"- Objective response rate (ORR), defined as percentage of objective responses (partial and complete responses combined /PR + CR/ by iRECIST response criteria) in MRI after 12 weeks. a. Partial response (PR)- at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD b. Complete response (CR)- disappearance of all target lesions and short dimension of all lymph nodes < 10 mm","definition_or_measurement_approach":"Measured by iRECIST response criteria on MRI after 12 weeks; PR defined as ≥30% decrease in sum LD of target lesions versus baseline; CR defined as disappearance of all target lesions and short axis of all lymph nodes < 10 mm."}

Secondary endpoints

• {"endpoint_text":"- Progression- free survival (PFS) by iRECIST criteria- from the beginning of treatment to the progression of disease or death. Progression will be evaluated in MRI (after 6 months of treatment phase) and defined according to iRECIST criteria.\n- Overall survival (OS) rate- time of total survival – at 6 months (treatment phase), 12 months and 18 months (6th month and 12th month of long term follow up)\n- DCR per RECIST (disease control rate)- defined as not meeting the criteria for progression and PR; measured in MRI from the start of the treatment until the criteria for disease progression is met.\n- DoR per RECIST (duration of response) – measured in MRI from the time when measurement criteria for complete/ partial response are met till time when progression of the disease is documented.\n- Change in quality of life in EORTC QLQ-C30 (version 3.0) from baseline to last infusion.\n- Change in quality of life in EORTC QLQ-C30 (version 3.0) - from baseline to last follow up.\n- Safety assessment of treatment with Nivolumab : • total rate of patient, who discontinues from infusion due to excesive toxicity, measured after end of treatment phase • time from start of treatment to occurrence of excesive toxicity preventing from continuation the infusion of Nivolumab, assessed at each visit during treatment phase.","definition_or_measurement_approach":"PFS: time from treatment start to progression or death assessed by iRECIST on MRI (evaluation after 6 months of treatment phase). OS: survival time evaluated at 6, 12 and 18 months. DCR: absence of progression and PR per RECIST on MRI. DoR: time from first meeting response criteria to documented progression per RECIST on MRI. QoL: change from baseline using EORTC QLQ-C30 v3.0. Safety: rates of discontinuation for toxicity and time to excessive toxicity assessed at each visit during treatment."}

Poland

Earliest CTIS Part Ii Submission Date

14-10-2024

Latest Decision Or Authorization Date

04-11-2025

Processing Time Days

386

Number Of Sites

4

Number Of Participants

32

Primary sponsor

Full Name

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"KCRI Sp. z o.o.","duties_or_roles":"codes: 1,11,12,5,6,7,8","organisation_type":"Pharmaceutical company"}