jRCT2031210650进行中（未招募）不适用
An open label trial of BI 765063 in combination with BI 754091 (ezabenlimab) alone or with BI 836880, chemotherapy, or cetuximab, in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) or hepatocellular carcinoma (HCC)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 主要终点
- Objective response (OR) with confirmation
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients homozygous for V1 allele (including V1-like alleles) of SIRPa
- •Patients with at least one measurable lesion as per RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status <=1
- •For patients with HNSCC only (Cohorts A and B)
- •Patients with recurrent or metastatic histologically or cytologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx which is considered incurable by local therapies (e.g. surgery, radiotherapy).
- •Immune checkpoint inhibitor naive patients who progressed on a standard platinum-based therapy in the recurrent/metastatic setting.
- •For patients with HCC only (Cohorts C, D, and E)
- •Patients with locally advanced/metastatic and/or unresectable HCC as confirmed histologically or by diagnostic imaging (dynamic Computed Tomography CT or Magnetic Resonance Imaging MRI) according to AASLD criteria
- •60 patients who have not received prior systemic therapy will be randomized in 2 1st line HCC.
- •30 patients who have progressed on 1st line atezolizumab+bevacizumab therapy/regimen will be included in a 2nd line HCC.
- •Child-Pugh Score of A.
排除标准
- •Patients with at least one SIRPa V2 allele, i.e. SIRPa V1/V2 or V2/V2 individuals.
- •Previous treatment with any anti-PD-(L)1, anti-SIRPa, or anti-VEGF (for cohorts using BI 836880 only), except for patients treated in 2nd line HCC cohort where previous treatment with atezolizumab+bevacizumab is required.
- •For patients with HNSCC only (Cohorts A and B )
- •Patients with nasopharyngeal carcinoma.
- •For patients with HCC only (Cohorts C, D and E)
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- •Tumour of diffuse infiltrative HCC type (hypovascular infiltrative tumours with ill-defined borders).
- •Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g. paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose.
- •History of recent bleeding disorders or risk of bleeding (including history of fistulae, GI perforation, or intra-abdominal abscess) within 6 months of initiation of study treatment.
- •Patients with untreated or incompletely treated varices with bleeding or high-risk for bleeding
结局指标
主要结局
Objective response (OR) with confirmation
时间窗: from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent
The best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1(v1.1) by investigators assessment
次要结局
- Duration of objective response (DOR)
- Disease control (CR, PR, or stable disease)
- Occurrence of treatment emergent adverse events (AEs)
- Progression-free survival (PFS)
研究者
相似试验
尚未招募
不适用
A study to compare the effects of combination of Ropivacaine and Nalbuphine with Ropivacaine alone in patients undergoing upper limb surgery under regional anaesthesiaCTRI/2019/03/017983Jln medical college
已完成
不适用
Study to investigate the interchangeability between different polio vaccines (OPV, IPV and DPT-IPV) based on immunogenicity and safetyJPRN-UMIN000022692College of Healthcare Management200
已完成
3 期
Studying the effectiveness of different number of Cryo compression Therapy sessions on pain, swelling, range of motion, opium consumption and blood lost after total knee arthroplasty.Total Knee Arthroplasty surgery following Osteoarthritis of the knee jointTotal Knee ReplacementCold TherapyTCTR20220124005Iran University of Medical Sciences63
尚未招募
1 期
Investigating the effectiveness of CO2 fractional laser and conditioned medium in the treatment of burn scarsburn scar.Atrophic disorders of skinIRCT20200127046282N33Tehran University of Medical Sciences18
已完成
4 期
Prospective, randomized comparison of two types of venous catheters, with a return membrane and without a return membrane, with regard to blood leakage during installation, puncture attemptsInfection risk for the user during venous catheter placementPuncture site infections after preclinical vein catheter placement.DRKS00029653niversitätsklinikum des SaarlandesKlinik für Anästhesiologie, Intensivmedizin und Schmerztherapie541