A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT06806852
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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 recent biopsy (<3 months) is preferred, however an archival biopsy up to 12 months prior to screening could be accepted. If these requirements cannot be met, then the patient may be allowed to enter the study at Sponsor discretion, after agreement between the Investigator and 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab Pembrolizumab - Pembrolizumab + BI 770371 BI 770371 - Pembrolizumab + BI 770371 Pembrolizumab - Pembrolizumab + BI 770371 + Cetuximab BI 770371 - Pembrolizumab + BI 770371 + Cetuximab Pembrolizumab - Pembrolizumab + BI 770371 + Cetuximab Cetuximab -
- Primary Outcome Measures
Name Time Method Objective response (OR) with confirmation 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.
- Secondary Outcome Measures
Name Time Method Occurrence of treatment related adverse event (AE) from first treatment administration until the earliest of death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent Up to 27 months Occurrence of treatment related adverse event (AE) leading to treatment discontinuation from first treatment administration until the earliest of death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent Up to 27 months Overall survival (OS) Up to 27 months OS defined as the time from first treatment administration until death from any cause.
Overall survival at 6 and 12 months (OS6 and OS12) At 6 months and 12 months OS defined as being alive at 6 months or at 12 months from first treatment administration.
Progression-free survival (PFS) 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.
Progression-free survival at 6 months (PFS6) At 6 months PFS defined as being alive and without progression at 6 months from first treatment administration.
Duration of objective response (DOR) 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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (55)
Norton Cancer Institute, Downtown
🇺🇸Louisville, Kentucky, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Gosford Hospital
🇦🇺Gosford, New South Wales, Australia
Andrew Love Cancer Centre
🇦🇺Geelong, Victoria, Australia
Hospital de Amor
🇧🇷Barretos, Brazil
Liga Norte Riograndense contra o cancer
🇧🇷Natal, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
🇧🇷São José do Rio Preto, Brazil
MBAL Sveta Sofia
🇧🇬Sofia, Bulgaria
CTR Oscar Lambret
🇫🇷Lille, France
CTR Leon Berard
🇫🇷Lyon Cedex 08, France
HOP Timone
🇫🇷Marseille, France
INS Gustave Roussy
🇫🇷Villejuif, France
ARENSIA Exploratory Medicine LLC
🇬🇪Tbilisi, Georgia
Städtisches Klinikum Braunschweig gGmbH
🇩🇪Braunschweig, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
Universität Leipzig
🇩🇪Leipzig, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Semmelweis University
🇭🇺Budapest, Hungary
National Institute of Oncology
🇭🇺Budapest, Hungary
Clinexpert Gyongyos
🇭🇺Gyongyos, Hungary
Istituto Scientifico Romagnolo
🇮🇹Meldola (fc), Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria "Federico II"
🇮🇹Napoli, Italy
Istittuo Nazionale Tumori Regina Elena - IRCCS
🇮🇹Roma, Italy
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
Hokkaido University Hospital
🇯🇵Hokkaido, Sapporo, Japan
Kobe University Hospital
🇯🇵Hyogo, Kobe, Japan
Kansai Medical University Hospital
🇯🇵Osaka, Hirakata, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Sunto-gun, Japan
Japanese Foundation for Cancer Research
🇯🇵Tokyo, Koto-ku, Japan
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, St.Vincent's Hospital
🇰🇷Suwon-si, Korea, Republic of
Centro Oncológico Internacional
🇲🇽Tlajomulco de Zuñiga, Mexico
Unidad Clinica Farmacologica Bioemagno
🇲🇽Ciudad de México, Mexico
Centro Oncologico Personalizado
🇲🇽Mexico, Mexico
ARENSIA Exploratory Medicine
🇲🇩Chisinau, Moldova, Republic of
Center of Oncology of the Lublin Region St. Jana z Dukli
🇵🇱Lublin, Poland
"Prof. Dr. Alexandru Trestioreanu" Oncology Institut
🇷🇴Bucharest, Romania
National University Hospital-Singapore-22806
🇸🇬Singapore, Singapore
Instituto Nacional de Cancerologia
🇲🇽Mexico, Mexico
National Oncology Institute Maria Sklodowskiej Curie State Research Institute
🇵🇱Gliwice, Poland
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Siriraj Hospital
🇹🇭Bangkoknoi, Thailand
Adana City Hospital
🇹🇷Adana, Turkey
Abdurrahman Yurtaslan Oncology Training and Research Hospital
🇹🇷Ankara, Turkey
Hacettepe University Oncology Hospital
🇹🇷Ankara, Turkey
Ankara Bilkent City Hospital
🇹🇷Ankara, Turkey
Istanbul University Medical Faculty Capa Hospital
🇹🇷Istanbul, Turkey
Ege University Tulay Aktas Oncology Hospital
🇹🇷Izmir, Turkey
St Bartholomew's Hospital
🇬🇧London, United Kingdom
The Royal Marsden Hospital, Chelsea
🇬🇧London, United Kingdom
The Royal Marsden Hospital, Sutton
🇬🇧Sutton, United Kingdom