2024-516005-23-00尚未招募2 期
SPARTANA : Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma. A Phase IIA study
Centre Hospitalier Regional Universitaire5 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年8月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 5
- 主要终点
- 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.
研究概览
简要总结
The primary objective of this clinical trial is to evaluate the Progression-Free Survival (PFS) rate at 1 year.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥18 years,
- •Signed 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
- •Patient affiliated to or beneficiary of French social security system
- •Ability to comply with the study protocol, in the Investigator’s judgment
- •Performance status Eastern Cooperative Oncology Group World Health Organization (ECOG-WHO) ≤1,
- •Histologically 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,
- •Patient eligible to the mDCF regimen
- •No previous systemic (immunotherapy or chemotherapy) treatment.
- •CT scan performed within 30 days prior inclusion,
- •PET scan performed within 30 days prior inclusion
- •Life expectancy ≥12 months,
- •Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment: a. Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L) without granulocyte colony-stimulating factor support. b. White blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L). c. Platelets ≥ 100,000/mm3 (≥ 100 GI/L) without transfusion. d. Hemoglobin ≥ 9 g/dL (≥ 90 g/L). e. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN), or ≤ 5 x ULN with documented liver metastases. f. Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert’s disease ≤ 3 x ULN). g. Serum albumin ≥ 2.8 g/dl. h. Calculated creatinine clearance ≥ 60 mL/min (using the MDRD formula): i. Urine protein/creatinine ratio (UPCR) ≤ 1 g/g
排除标准
- •HIV positive patient , CD4 count < 400 cells/mm3 (HIV test mandatory before inclusion)
- •Untreated 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
- •Use 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.
- •Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment
- •Elevated Cardiac troponin T (cTnT) or cardiac troponin I (cTnI) elevation > 2x ULN
- •Systemic 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
- •Active, 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.
- •Allogenic bone marrow or solid organ transplant
- •History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction
- •Pre-existing neuropathy, hearing problem, or cardiorespiratory pathology, which prevent the administration of cisplatin.
- •clinically significant active heart disease or myocardial infarction within 6 months
- •Diagnosis 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,
- •recent or concomitant treatment with brivudine
- •persistent toxicities related to prior treatment of grade greater than 1
- •History or current interstitial lung disease or non-infectious pneumonitis
- •History of major surgery within 28 days before treatment
- •Active infection
- •Active Hepatitis B infection (HBsAg positive)
- •Active hepatitis C (HCV RNA positive)
- •Pregnant 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.
- •Women 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.
- •Complete or partial deficit in dihydropyrimidine dehydrogenase (DPD) activity
- •Any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study,
- •Active inflammatory bowel disease
- •Current participation in a study of an investigational agent or in the period of exclusion,
- •Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment,
- •Radiation 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,
- •Pregnancy, 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,
- •Patient under guardianship, curatorship or under the protection of justice.
- •Inability to perform radiotherapy
结局指标
主要结局
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.
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.
次要结局
未报告次要终点
研究者
Chargé de projet
Scientific
Centre Hospitalier Regional Universitaire
研究点 (5)
Loading locations...
相似试验
招募中
3 期
Phase III randomized clinical trial evaluating hyperthermic intraperitoneal chemotherapy (HIPEC) in ovarian cancer considering two different settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)2024-514706-31-01Centre Oscar Lambret352
招募中
2 期
Phase II Study of Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian CancerOvarian CancerNCT07261683Obstetrics & Gynecology Hospital of Fudan University20
撤回
3 期
HARMONi-32023-504989-37-00Summit Therapeutics Sub Inc.135
招募中
2 期
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease2023-507303-55-00Eli Lilly & Co.224
进行中（未招募）
3 期
评估 IBI363 对比多西他赛在经含铂化疗及抗 PD-1/PD-L1 免疫治疗失败的局部晚期或转移性鳞状非小细胞肺癌患者中的有效性和安全性的随机、开放、多中心、III 期研究CTR20253956180