Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment

Официальное название

Phase II Study Evaluating the Efficacy of Nivolumab in the Treatment of Patients With Nasopharyngeal Cancer Who Progressed During or After Platinum-based Chemotherapy

Обзор

Multicentre , non-randomized, prospective clinical trial to assess efficacy of Nivolumab in treatment of nasopharyngeal cancer who progressed during or after platinum-based chemotherapy . Patients disqualified from radical therapy . The total number of patients was estimated for 32.

Вмешательства

• Препарат Opdivo
  Dose of Nivolumab is constant and is 240 mg .All patients will undergo maximum of 12 cycles of investigation product's infusion ( around 6 month of treatment).Each cycle will be done in intervals of 14 day (no less than 12 days after previous infusion and no longer than 42 day/6 weeks after previous infusion).

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: 12 weeks]

Вторичные конечные точки (6)

• 1.Progression- free survival (PFS) by iRECIST( immune Response Evaluation Criteria in Solid Tumours) criteria- from the beginning of treatment to the progression of disease or death. [Срок оценки: 6 month of treatment phase]
• Overall survival (OS) rate- time of total survival [Срок оценки: at 6 months (treatment phase), 12 months and 18 months (6th month and 12th month of long term follow up)]
• DCR(disease control rate) per RECIST (Response Evaluation Criteria in Solid Tumours) [Срок оценки: through study completion, an average of 6 months]
• DoR(duration of response) per RECIST (Response Evaluation Criteria in Solid Tumours) [Срок оценки: through study completion, an average of 1 year]
• Change in quality of life in EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) (version 3.0) .A high scale score represents a higher response level. [Срок оценки: from first infusion to last follow up ( 3 month, 6 month, 9 month,12month follow up)]
• Safety assessment of treatment with Nivolumab measured by excesive toxity [Срок оценки: Each visit during treatment phase -12 cycles of investigation product's infusion (around 6 month of treatment).]

Критерии участия

Критерии включения

• Age > 18 years old
• Histological or cytological documentation of squamous cell carcinoma.
• Primary tumor location in nasopharynx
• Previous, documented failure on platinum-based chemotherapy or progression of the disease during platinum-based chemotherapy
• Tumor recurrence (local or nodal) or generalization (metastasis) occurence during or within 6 months after previous platinum-based chemotherapy
• ECOG(Eastern Cooperative Oncology Group) performance scale 0-1
• 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.

Критерии исключения

• Known active central nervous system metastases.
• Presence of renal insufficiency defined as eGFR(estimated glomerular filtration rate) < 30 ml/min/m2
• Presence of liver disfunction, defined as level of AST(aspartate aminotransferase) and /or ALT(alanine aminotransferase) > 2,5 x ULN(upper limits of normal) (> 5 x ULN in patients with documented liver metastases); total bilirubin > 1,5 xULN ( bilirubin > 1,5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%) or albumin < 2,5 g/dL
• Abnormalities in blood count such as: hemoglobin < 9 g/dl, platelets < 100 x 109 /L, Absolute Neutrophil Count (ANC) <1,0 x 109 /L
• Ejection fraction in echocardiography < 50%
• History of active autoimmune diseases except for type I diabetes, hypothyroidism (treated only with hormone supplementation), psoriasis, albinism.
• Patient with diagnosed mental disorder preventing, in Investigator's opinion, from participating in a clinical trial.
• Pregnancy or breastfeeding.
• 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)
• Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent
• Patient is currently participating in another clinical trial.
• Active infection, which significantly affects the patient's clinical condition and requires treatment.
• Patient with prior bone marrow or solid organ transplantation.
• Patient requires immunosuppressive agents, including steroids (daily dose of prednisone or equivalent > 10 mg)
• Known immunodeficiency including HIV/AIDS(human immunodeficiency virus/acquired immunodeficiency syndrome) infection.
• Patient received any live vaccine within 28 days before enrollment.
• Heart Failure - NYHA(New York Heart Association functional classification system) III or IV
• 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.
• Other comorbidities symptoms or conditions that in Investigator's judgement prevent patient from participation in clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Польша · 4 центра

• Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego Szpitala Klinicznego w Bi — Bialystok
• Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego — Gdansk
• Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skło — Gliwice
• Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii — Kielce

Идентификаторы

NCT: NCT04875611 · 20-NIO-0003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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