CTRI/2024/12/077942招募中4 期
A phase 4, multicenter, noncomparative, open-label, two cohort study evaluating the safety and efficacy of intravenously administered toripalimab in the treatment of Indian patients with recurrent or metastatic nasopharyngeal carcinoma
Dr. Reddys Laboratories Ltd.12 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月20日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)
研究概览
简要总结
Toripalimab(PD-1 inhibitor) is approved in the United States for NPC.In China, it is approved (under the brand name TUOYI®) for multiple oncology indications including NPC.
The proposed study is "A phase 4, multicenter, noncomparative, open-label, two cohort study evaluating the safety and efficacy of intravenously administered toripalimab in the treatment of Indian patients with recurrent or metastatic nasopharyngeal carcinoma".The trial will include a screening period(up to 4 weeks),a treatment phase(8 weeks for cohort-1 and 12 weeks for cohort -2). the total duration of individual participation will be approximately 25 weeks.
Patients who qualify the selection criteria will be selected for either of the cohort-1 or cohort-2 and Toripalimab will be administered intravenously either with the standard chemotherapy drugs cispaltin and gemcitabine for every 3 weeks or as monotherapy for every 2 weeks.Safety and efficacy assessments will be done as per the planned time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age ≥18 years and ≤75 years.
- •Histological/cytological confirmation of NPC.
- •Patients with cohort 1: De novo metastatic stage IVB NPC without previous systemic chemotherapy OR Recurrent NPC without previous systemic chemotherapy not amenable for locoregional treatment or curative treatment OR Recurrent NPC after curative treatment (including radiotherapy and/or induction, concurrent or adjuvant chemotherapy), with an interval between recurrence and the last dose of previous radiotherapy or chemotherapy of more than 6 months.
- •Cohort 2 Unresectable or metastatic NPC who had received prior platinum-based chemotherapy for treatment of recurrent or metastatic NPC or had disease progression within 6 months of completion of platinum-based chemotherapy administered as neoadjuvant, adjuvant, or definitive chemoradiation treatment for locally advanced disease.
- •Patients with at least 1 measurable lesion according to RECIST v1.1 criteria.
- •Life expectancy ≥3 months.
- •ECOG performance status ≤2
- •Patients demonstrating adequate organ function as defined by following values for clinical laboratory all parameters performed within 96 hours of treatment initiation (unless dysfunction is felt to be secondary as determined by the treating investigator) a.
- •Hematology: Leukocytes more than 3.0 109 per L, absolute neutrophil count (ANC) less than 1.5 109 per L, hemoglobin ≥9 g/dL, and platelet count more than 100 × 109 per litre.
- •Liver function tests: Bilirubin ≤1.5× upper limit of normal (ULN) or direct bilirubin less than ULN for patients with total bilirubin levels more than 1.5 ULN (patients with known Gilberts disease who have serum bilirubin level less than 3 ULN may be enrolled); aspartate aminotransferase and alanine aminotransferase; alkaline phosphatase less than 3 ULN [ALP less than 5 ULN if liver or bone metastases]; international normalized ratio or activated partial thromboplastin time less than 1.5 ULN.vq.
- •Renal function tests: Serum creatinine less than 1.5 ULN and creatinine clearance more than 60 mL per min according to Cockcroft-Gault formula
- •Patients who have experienced toxicities from any prior therapy, surgery, or radiotherapy only if severity is resolved to grade 0 or 1 as per the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE).
- •Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- •Women patients if they are of: Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including women who have had a hysterectomy, bilateral oophorectomy (ovariectomy), or bilateral tubal ligation or are postmenopausal (total cessation of menses for ≥1 year).
- •Childbearing potential and have a negative serum pregnancy test at screening (within 7 days of the first administration of study intervention), have used adequate contraception before study entry, with use adequate contraception throughout the study until 4 months after the last administration of study intervention.
排除标准
- •1.Patients with history of severe hypersensitivity reactions to toripalimab, other monoclonal antibodies (mAbs), or any excipient of toripalimab injection such as citrate, sodium citrate, sodium chloride, mannitol, or polysorbate
- •Patients with active or untreated central nervous system metastases as determined on computed tomography or magnetic resonance imaging during screening and/or prior radiographic assessments.
- •Patients who have received prior therapies for brain or leptomeningeal metastasis should be clinically stabilized for more than 2 months and should have discontinued systemic steroids therapy more than 4 weeks before Day 1 of Cycle 1 to be eligible for inclusion.
- •This exception does not include patients with carcinomatous meningitis as they will be excluded regardless of clinical stability.
- •3.Patients with spinal cord compression not definitively treated with surgery and/or radiation or patients with previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for more than 2 weeks prior to Day 1 of Cycle
- •Patients with necrotic lesions that have potential risk of massive hemorrhage at the discretion of investigator.
- •Patients with uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- •Patients with indwelling catheters (e.g., PleurX catheter) may be enrolled as per investigator discretion after discussion with sponsor medical monitor.
- •Patients with malignancies other than NPC within 5 years prior to Day 1 of Cycle
- •Such patients may be enrolled only if they have a negligible risk of metastasis or death and have experienced expected curative outcome after treatment (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated surgically with curative intent).
- •Patients who have received prior therapy targeting PD-1 receptor, its ligand PD-L1, or cytotoxic T-lymphocyte-associated protein 4 (CTLA4) receptor.
- •Patients on antineoplastic traditional herbal medicine within 4 weeks before first dosing cycle.
- •Patients who have not recovered from the effects of major surgery or significant traumatic injury other than diagnosis of NPC at least 14 days before the first dose of study treatment.
- •Patients with history of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- •Patients who have received systemic immunostimulatory agents (including, but not limited to, interferons or interleukin 2) within 4 weeks or 5 half-lives of toripalimab, whichever is shorter, prior to first dosing cycle.
- •Patients who have received systemic corticosteroids or other systemic immunosuppressive medications (including, but not limited to, prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to first dosing cycle.
- •Patients contraindicated for IV contrast requiring steroid pretreatment should have baseline and subsequent tumor assessments performed on MRI.
- •Patients who have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)
时间窗: Baseline up to end of study (EoS) for both the cohorts | cohort-1-screening, week-1,4,7,10,13,16,19,22 and 25 | cohort-2-screening,week- 1,3,5,7,9,11,13,15,17,19,21,23 and 25
次要结局
- Safety End points:-(-Incidence of AESIs including immune-related adverse events (AEs), anaphylactic reactions, hypersensitivity reactions and other infusion-related reactions.)
研究者
研究点 (12)
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