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一项研究，用于测试BI 770371与pembrolizumab结合使用或不带西妥昔单抗的研究是否有助于单独使用pembrolizumab的头和颈部癌的人

2026年10月27日 更新者：Boehringer Ingelheim

一项IB期开放标记随机临床试验，以评估BI 770371与Pembrolizumab结合使用或不使用西替昔昔单抗的Pembrolizumab，与Pembrolizumab单疗法相比

This study is open to adults with head and neck cancer. The purpose of this study is to find out whether combining different study medicines makes tumors shrink in people with head and neck cancer.

The tested medicines in this study are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing.

Participants are put into 3 groups randomly. Each group receives a different combination of study medicines. All study medicines are given as an infusion into a vein at the study site.

Participants can stay in the study as long as they benefit from treatment. Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

91

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 乔治亚州
      • Tbilisi、乔治亚州、0112
        • ARENSIA Exploratory Medicine LLC
  • 保加利亚
      • Sofia、保加利亚、1404
        • MBAL Sveta Sofia
  • 匈牙利
      • Budapest、匈牙利、1083
        • Semmelweis University
      • Gyöngyös、匈牙利、3200
        • Clinexpert Gyongyos
  • 台湾
      • Taipei、台湾、11217
        • Taipei Veterans General Hospital
      • Taipei、台湾、10048
        • National Taiwan University Hospital
  • 土耳其（türkiye）
      • Adana、土耳其（türkiye）、01220
        • Adana City Hospital
      • Ankara、土耳其（türkiye）、06800
        • Ankara Bilkent City Hospital
      • Ankara、土耳其（türkiye）、06200
        • Abdurrahman Yurtaslan Oncology Training and Research Hospital
      • Ankara、土耳其（türkiye）、06230
        • Hacettepe University Oncology Hospital
      • Istanbul、土耳其（türkiye）、34093
        • Istanbul University Medical Faculty Capa Hospital
  • 墨西哥
      • Mexico City、墨西哥、04660
        • Unidad Clinica Farmacologica Bioemagno
      • México、墨西哥、14080
        • Instituto Nacional de Cancerologia
      • México、墨西哥、06760
        • Centro Oncologico Personalizado
      • Tlajomulco de Zuñiga、墨西哥、45640
        • Centro Oncológico Internacional
  • 巴西
      • Barretos、巴西、14784-400
        • Hospital de Amor
      • Natal、巴西、59062-000
        • Liga Norte Riograndense contra o cancer
      • São José do Rio Preto、巴西、15090-000
        • Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • 德国
      • Braunschweig、德国、38114
        • Städtisches Klinikum Braunschweig gGmbH
      • Jena、德国、07743
        • Universitätsklinikum Jena
      • Leipzig、德国、04103
        • Universität Leipzig
      • Ulm、德国、89081
        • Universitätsklinikum Ulm
  • 意大利
      • Meldola (FC)、意大利、47014
        • Istituto Scientifico Romagnolo
      • Verona、意大利、37126
        • Azienda Ospedaliera Universitaria Integrata Verona
  • 摩尔多瓦
      • Chisinau、摩尔多瓦、MD-2025
        • ARENSIA Exploratory Medicine
  • 新加坡
      • Singapore、新加坡、119228
        • National University Hospital-Singapore-22806
  • 日本
      • Hokkaido, Sapporo、日本、060-8648
        • Hokkaido University Hospital
      • Hyogo, Kobe、日本、650-0017
        • Kobe University Hospital
      • Osaka, Hirakata、日本、573-1191
        • Kansai Medical University Hospital
      • Shizuoka, Sunto-gun、日本、411-8777
        • Shizuoka Cancer Center
      • Tokyo, Koto-ku、日本、135-8550
        • Japanese Foundation for Cancer Research
  • 法国
      • Lille、法国、59020
        • CTR Oscar Lambret
      • Lyon、法国、69373
        • CTR Leon Berard
      • Marseille、法国、13385
        • HOP Timone
      • Villejuif、法国、94805
        • Institut Gustave Roussy
  • 波兰
      • Lublin、波兰、20090
        • Center of Oncology of the Lublin Region St. Jana z Dukli
  • 泰国
      • Bangkoknoi、泰国、10700
        • Siriraj Hospital
  • 澳大利亚
    • New South Wales
      • Gosford、New South Wales、澳大利亚、2250
        • Gosford Hospital
    • Victoria
      • Geelong、Victoria、澳大利亚、3220
        • Andrew Love Cancer Centre
  • 瑞士
      • Aarau、瑞士、5001
        • Cantonspital Aarau
  • 罗马尼亚
      • Bucharest、罗马尼亚、022328
        • "Prof. Dr. Alexandru Trestioreanu" Oncology Institut
  • 美国
    • Kentucky
      • Louisville、Kentucky、美国、40202
        • Norton Cancer Institute, Downtown
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • M Health Fairview Clinics and Surgery Center - Minneapolis
    • Ohio
      • Columbus、Ohio、美国、43210
        • The Ohio State University Wexner Medical Center
  • 英国
      • London、英国、EC1A 7BE
        • St Bartholomew's Hospital
      • London、英国、SW3 6JJ
        • The Royal Marsden Hospital, Chelsea
      • Sutton、英国、SM2 5PT
        • The Royal Marsden Hospital, Sutton
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Universitari Vall d'Hebron
  • 韩国
      • Seoul、韩国、03722
        • Severance Hospital
      • Seoul、韩国、135-710
        • Samsung Medical Center
      • Suwon、韩国、16247
        • The Catholic University of Korea, St.Vincent's Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients with histologically confirmed metastatic or recurrent HNSCC of the primary tumour location of oral cavity, oropharynx, hypopharynx, and larynx not amenable to locoregional treatment with curative intent.
  • Willingness to provide pretreatment (baseline) biopsy/tissue to the sponsor (fresh or archival one). A newly obtained biopsy is preferred but an archival sample is acceptable, with tumor tissue (formalin fixed paraffin embedded [FFPE] block preferred, or at least 10 freshly sectioned unstained FFPE slides) from a core or excisional biopsy. Any deviation from this rule requires approval by the sponsor. Details on the requirements for archival tumour tissue and on biopsy sample collection are provided in the Laboratory Manual.
  • Patients who have not received prior systemic treatment for metastatic or recurrent HNSCC. Systemic therapy (including cetuximab) which was completed more than 6 months prior to progression of disease if given as part of multimodal treatment for locally advanced disease is allowed.
  • Patients who do not have contraindications to pembrolizumab monotherapy according to pembrolizumab local label, guidelines, treatment standards, regulations or the document (label of another country if pembrolizumab local label is not available) provided in the investigator site file (ISF) by the sponsor.
  • Patients who do not have contraindications to treatment with cetuximab according to cetuximab local label, guidelines, treatment standards, regulations, or the document (label of another country if cetuximab local label is not available) provided in the ISF by the sponsor.
  • Presence of at least one measurable non-central nervous system (CNS) lesion (according to RECIST v1.1.).
  • Further inclusion criteria apply.

Exclusion Criteria:

  • Nasopharyngeal carcinoma (NPC) of any histology, primary tumour location at nasal cavity, paranasal sinuses of any histology, any cancer of unknown primary.
  • Any tumour location necessitating an urgent therapeutic intervention (e.g., palliative care, surgery, or radiation therapy), such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture.
  • Patients with progressive HNSCC within 6 months of completion of systemic therapy for locoregionally advanced disease with curative intent.
  • Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or endpoint assessment. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to trial entry, have discontinued corticosteroid treatment for these metastases and are clinically stable, off anticonvulsants for at least 4 weeks and are neurologically stable before enrollment.
  • Patients for whom single agent pembrolizumab is not the preferred treatment (e.g. patients for whom chemotherapy or anti-PD-1 in combination with chemotherapy is considered the preferred therapy by the investigator or treating physician).
  • Prior treatment with any anti signal regulatory protein alpha (SIRPα) or anti-integrin-associated protein (CD47) agent, regardless of treatment intent.
  • Prior cancer treatment with any anti PD-1 or anti PD-L1 agent or with an agent directed to another stimulatory or co-inhibitory Tcell receptor (e.g. CTLA-4, OX 40, CD137), regardless of treatment intent.
  • Prior allogeneic stem cell or solid organ transplantation.
  • Further exclusion criteria apply.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：派姆单抗
药品：Pembrolizumab

Pembrolizumab
实验性的：Pembrolizumab + BI 770371
药品：Pembrolizumab

Pembrolizumab

药品：BI 770371

BI 770371
实验性的：Pembrolizumab + BI 770371 +西妥昔单抗
药品：Pembrolizumab

Pembrolizumab

药品：BI 770371

BI 770371

药品：Cetuximab

Cetuximab

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Objective response (OR) with confirmation
大体时间：Up to 27 months

OR defined as 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 version 1.1 (RECIST v1.1).

Objective response (OR) will be defined by investigator's assessment from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent.
Up to 27 months

次要结果测量

结果测量
措施说明
大体时间
从第一次治疗管理到最后剂量后90天，死亡，随后的抗癌治疗后90天，与治疗相关的不良事件（AE）的发生，失去了随访或撤回同意
大体时间：长达27个月
长达27个月
与治疗相关的AE的发生，导致从第一次治疗管理到上次剂量后90天，死亡，随后的抗癌治疗后最早的治疗中停用，丢失了随访或撤回同意
大体时间：长达27个月
长达27个月
Overall survival (OS)
大体时间：Up to 27 months

OS defined as the time from first treatment administration until death from any cause.
Up to 27 months
Overall survival at 6 and 12 months (OS6 and OS12)
大体时间：At 6 months and 12 months

OS defined as being alive at 6 months or at 12 months from first treatment administration.
At 6 months and 12 months
Progression-free survival (PFS)
大体时间：Up to 27 months

PFS defined as the time from first treatment administration until disease progression (PD) according to RECIST v1.1 or death from any cause, whichever occurs earlier.
Up to 27 months
Progression-free survival at 6 months (PFS6)
大体时间：At 6 months

PFS defined as being alive and without progression at 6 months from first treatment administration.
At 6 months
Duration of objective response (DOR)
大体时间：Up to 27 months

DOR defined as the time from first documented CR or PR (RECIST v1.1) until the earliest of PD or death among patients with OR.
Up to 27 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Boehringer Ingelheim

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年5月14日

初级完成 (估计的)

2027年8月31日

研究完成 (估计的)

2027年8月31日

研究注册日期

首次提交

2025年1月28日

首先提交符合 QC 标准的

2025年1月28日

首次发布 (实际的)

2025年2月4日

研究记录更新

最后更新发布 (实际的)

2026年10月28日

上次提交的符合 QC 标准的更新

2026年10月27日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1501-0002
  • U1111-1312-0435 (注册表标识符：WHO International Clinical Trials Registry Platform (ICTRP))
  • 2024-517091-38-00 (注册表标识符：CTIS (EU))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD 共享时间框架

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD 共享访问标准

For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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