2024-517205-82-00招募中2 期
A multicentre, open-label phase 2 study to evaluate the efficacy and safety of pembrolizumab in the treatment of advanced, progressive adrenocortical carcinoma
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年9月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Evaluation of the efficacy of pembrolizumab in the treatment of advanced progressive adrenocortical cancer
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Informed consent form to participate in the study
- •Age over 18
- •Histopathologically confirmed adrenal cortex cancer
- •The patient's general condition assessed according to the ECOG scale < 2
- •Measurable disease according to RECIST 1.1
- •Confirmed progression according to RECIST 1.1 within the last 6 months in patients who received at least 1 line of treatment with EDP or EDP-M
- •Adequate function of the bone marrow and internal organs: a. hemoglobin ≥ 9g%, neutrophils > 1500/mm3, platelets > 100 thousand/mm3 b. bilirubin ≤ 2 x upper limit of normal (ULN), Alat, AST ≤ 3 x ULN (in the presence of liver metastases ≤ 5 x ULN) c. creatinine clearance > 40ml/min d. coagulation parameters: INR, PT, APTT < 1.5 x ULN (exception: patients undergoing anticoagulation therapy, where INR, PT, APTT remain within the therapeutic range recommended for a given patient)
- •For women of reproductive age: confirmed negative pregnancy test result and the need to use double barrier contraception
- •For men of reproductive age: the need to use double barrier contraception
排除标准
- •Pretreatment with an immune checkpoint inhibitor
- •Hepatitis B or C
- •Active tuberculosis
- •Current active infection requiring systemic treatment
- •Symptomatic, untreated CNS metastases (exception: patients with asymptomatic CNS metastases, after previous surgical or radiotherapy treatment and without a history of intracranial bleeding)
- •Circulatory failure NYHA ≥3
- •Corrected QT interval > 500 ms
- •Significant comorbid disease, including cancer, with the exception of basal cell carcinoma of the skin, in situ cancers: prostate, cervix, breast
- •Another significant comorbid condition that, in the investigator's opinion, would pose a threat to the patient during therapy
- •Pregnancy or breastfeeding
- •Patients requiring dialysis
- •Any anticancer therapy in the last 7 days
- •Inability of the patient to meet the requirements specified in the study protocol
- •Vaccination with a live vaccine within 3 months before starting treatment
- •Persistent side effects of previously used anticancer therapy at stage > G1 or after previous surgical treatment (exception: alopecia)
- •Current or recent immunosuppressive therapy
- •Therapy with glucocorticosteroids at a dose higher than the replacement dose (subject to permissible use: inhaled or topical steroids, single administration of a steroid, e.g. in the case of an allergic reaction to contrast, the use of mineralocorticoids, steroids in the course of asthma)
- •Previous allogeneic bone marrow transplant or organ transplant
- •Autoimmune disease present or diagnosed within the last 2 years, except for vitiligo, psoriasis not requiring systemic treatment, autoimmune thyroid disease
- •Active or previously documented inflammatory bowel disease
- •Previous non-infectious pneumonia requiring steroid therapy
结局指标
主要结局
Overall Survival (OS)
Overall Survival (OS)
Objective Response Rate (ORR)
Objective Response Rate (ORR)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Duration of Response (DoR)
Duration of Response (DoR)
次要结局
- Quality of life assesed by QLQ-C30 questionnaire
- Number of Adverse Events and Serious Adverse Events (AEs and SAEs) related and unrelated to treatment according to CTCAE
研究者
Clinical Research Support Center
Scientific
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
研究点 (4)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous CarcinomaCTIS2023-507324-23-00K-Group Beta Inc.120
进行中（未招募）
1 期
Early stage clinical trial to investigate whether the Oxabact OC5 product reduces oxalate levels in the blood of patients with primary hyperoxaluria(a disease affecting the kidneys) who are on dialysisPrimary Hyperoxaluria (PH)MedDRA version: 20.1Level: PTClassification code 10020703Term: HyperoxaluriaSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2013-004368-74-DEOxThera Intellectual Property AB12
尚未招募
Unknown
A phase 2, multi-center, open-label study to evaluate the safety, tolerability and efficacy of combination regimen of GI-101A and SL-T10 in patients with metastatic castration-resistant prostate cancer (mCRPC)NeoplasmsKCT0008799Asan Medical Center72
进行中（未招募）
不适用
A phase II, open-label, multicentre study to evaluate the pharmacodynamic profile, the efficacy and the safety of a 6-month sustained-release formulation of triptorelin in patients with prostate cancer - Not applicableEUCTR2006-007055-41-LTBeaufour Ipsen Pharma - 24, rue Erlanger 75016 Paris FRANCE12
进行中（未招募）
1 期
A phase II, open-label, multicentre study to evaluate the safety and immunogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine as a booster dose in children aged 12 to 18 months, previously primed with the same vaccine in the primary vaccination study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157). - DTPA-HBV-IPV=HIB-MENC-TT-004 BST: 002Booster immunization of healthy children in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib) and serogroup C meningococcal (Men C) diseases.EUCTR2010-019253-18-PLGlaxoSmithKline Biologicals