2024-512834-14-00招募中2 期
A Phase II single-arm study of pembrolizumab plus lenvatinib in previously treated classic Kaposi sarcoma (CKS)
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年12月2日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is to estimate the overall response rate (ORR) during treatment with pembrolizumab and lenvatinib in patients with previously treated relapsed/refractory classic Kaposi sarcoma.
研究概览
简要总结
The main objective of the study is to evaluate the response rate to the treatment with pembrolizumab and lenvatinib in patients with previously treated relapsed/refractory Kaposi sarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Follow-up period
- 盲法
- None
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
- 是
入选标准
- •Histologic diagnosis of classic Kaposi sarcoma;
- •progression, relapse or inadequate response to at least one prior systemic chemotherapy;
- •presence of measurable disease by Positron Emission Tomography-Computed Tomography (PET-CT) scan and/or dermatological examination;
- •at least 1 superficial lesion willing to provide tissue from cutaneous and/or mucosal biopsy at baseline;
- •be = 18 years of age at the time of signing informed consent;
- •have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 within 7 days before the first dose of study intervention;
- •have adequate bone marrow, liver and renal function;
- •have adequately controlled blood pressure.
排除标准
- •Has a known history of human immunodeficiency virus (HIV) infection, of active infectious hepatitis type B (hepatitis B surface antigen [HBsAg] detected) or C (hepatitis C virus [HCV] ribonucleic acid [RNA] detected) or active Tuberculosis Bacillus (TB);
- •presence of known additional malignancy that is progressing or requires active treatment;
- •has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs);
- •has had an allogeneic tissue/solid organ transplant;
- •significant cardiovascular impairment within 12 months of the first dose of study intervention;
- •history of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral study drug absorption;
- •previous immunotherapy with ICI(s).
结局指标
主要结局
The primary endpoint of the study is to estimate the overall response rate (ORR) during treatment with pembrolizumab and lenvatinib in patients with previously treated relapsed/refractory classic Kaposi sarcoma.
The primary endpoint of the study is to estimate the overall response rate (ORR) during treatment with pembrolizumab and lenvatinib in patients with previously treated relapsed/refractory classic Kaposi sarcoma.
次要结局
- To estimate the duration of response (DOR) in patients with pre-treated recurrent CKS receiving pembrolizumab with lenvatinib
- to estimate the progression free survival (PFS);
- to estimate the overall survival (OS);
- to estimate the mean change from baseline in the global health status/quality of life (QoL), and physical functioning for the combinations of pembrolizumab and lenvatinib;
- to estimate the safety and tolerability for the combination of pembrolizumab and lenvatinib
- to evaluate changes in plasma levels of HHV8 DNA at baseline and at the time of treatment discontinuation, due to any cause (i.e. disease progression, complete response, unacceptable treatment related toxicity)
- to evaluate changes in plasma levels of circulating markers (i.e. PD-1/PD-L1, VEGF, VEGF-R) at baseline and at the time of treatment discontinuation, due to any cause (i.e. disease progression, complete response, unacceptable treatment related toxicity)
- to analyze PD-L1 and VEGF expression, and tumor infiltrating lymphocytes in tumor specimens at baseline and at the time of disease progression (optional)
研究者
Ornella Garrone
Scientific
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Study on Pembrolizumab in preneoplastic high grade HPV-related vulvar and cervical lesionsPatients with pre neoplastic high grade HPV-related vulvar and cervical lesionsMedDRA version: 20.0Level: PTClassification code 10054932Term: Vulvar dysplasiaSystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 20.0Level: PTClassification code 10008263Term: Cervical dysplasiaSystem Organ Class: 10038604 - Reproductive system and breast disordersEUCTR2019-002247-23-ITFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE46
招募中
2 期
Randomized Phase II, 2-arm study of Pembrolizumab after high dose radiation (SBRT) versus Pembrolizumab alone in patients with advanced non-small cell lung cancer.Non small cell lung cancer10038666lung cancerNL-OMON44895Antoni van Leeuwenhoek Ziekenhuis74
进行中（未招募）
1 期
Pembrolizumab after high dose radiation versus Pembrolizumab alone in patients with non-small cell lung cancer.Advanced non-small cell lung cancerMedDRA version: 19.0Level: LLTClassification code 10025048Term: Lung cancer non-small cell recurrentSystem Organ Class: 100000004864EUCTR2014-005118-49-NLStichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
进行中（未招募）
2 期
A phase 2 study of pembrolizumab in combination with olaparib in patients with cervical cancer previously treated with platinum-based chemotherapyrecurrent or metastatic cervical cancercervical cancer ,Pembrolizumab,OlaparibJPRN-jRCT2031210096Hasegawa Kosei28
招募中
不适用
A Prospective Phase II Trial of Pembrolizumab Plus Lenvatinib in Advanced Adrenal Cortical Carcinoma After Failure of Platinum- and Mitotane-Based Chemotherapy (ACCOMPLISH)NeoplasmsKCT0006789ational Cancer Center30