Clinical trial NCT06806852: 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
Official title: A Phase Ib Open Label Randomised Clinical Trial to Evaluate Safety and Efficacy of BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Compared With Pembrolizumab Monotherapy for the First-line Treatment of Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-02-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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.

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.

Primary outcomes:
measure: Objective response (OR) with confirmation
timeFrame: Up to 27 months
Secondary outcomes:
measure: 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
timeFrame: Up to 27 months
measure: 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
timeFrame: Up to 27 months
measure: Overall survival (OS)
timeFrame: Up to 27 months
measure: Overall survival at 6 and 12 months (OS6 and OS12)
timeFrame: At 6 months and 12 months
measure: Progression-free survival (PFS)
timeFrame: Up to 27 months
measure: Progression-free survival at 6 months (PFS6)
timeFrame: At 6 months
measure: Duration of objective response (DOR)
timeFrame: Up to 27 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute, Downtown
state: Kentucky
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio
state: Texas
city: Gosford
country: Australia
facility: Gosford Hospital
state: New South Wales
city: Geelong
country: Australia
facility: Andrew Love Cancer Centre
state: Victoria
city: Barretos
country: Brazil
facility: Hospital de Amor
city: Natal
country: Brazil
facility: Liga Norte Riograndense contra o cancer
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
city: Sofia
country: Bulgaria
facility: MBAL Sveta Sofia
city: Lille
country: France
facility: CTR Oscar Lambret
city: Lyon Cedex 08
country: France
facility: CTR Leon Berard
city: Marseille
country: France
facility: HOP Timone
city: Villejuif
country: France
facility: INS Gustave Roussy
city: Tbilisi
country: Georgia
facility: ARENSIA Exploratory Medicine LLC
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Leipzig
country: Germany
facility: Universität Leipzig
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Gyongyos
country: Hungary
facility: Clinexpert Gyongyos
city: Meldola (fc)
country: Italy
facility: Istituto Scientifico Romagnolo
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II"
city: Roma
country: Italy
facility: Istittuo Nazionale Tumori Regina Elena - IRCCS
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Hokkaido, Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Hyogo, Kobe
country: Japan
facility: Kobe University Hospital
city: Osaka, Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Shizuoka, Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo, Koto-ku
country: Japan
facility: Japanese Foundation for Cancer Research
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St.Vincent's Hospital
city: Ciudad de México
country: Mexico
facility: Unidad Clinica Farmacologica Bioemagno
city: Mexico
country: Mexico
facility: Centro Oncologico Personalizado
city: Mexico
country: Mexico
facility: Instituto Nacional de Cancerologia
city: Tlajomulco de Zuñiga
country: Mexico
facility: Centro Oncológico Internacional
city: Chisinau
country: Moldova, Republic of
facility: ARENSIA Exploratory Medicine
city: Gliwice
country: Poland
facility: National Oncology Institute Maria Sklodowskiej Curie State Research Institute
city: Lublin
country: Poland
facility: Center of Oncology of the Lublin Region St. Jana z Dukli
city: Bucharest
country: Romania
facility: "Prof. Dr. Alexandru Trestioreanu" Oncology Institut
city: Singapore
country: Singapore
facility: National University Hospital-Singapore-22806
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Aarau
country: Switzerland
facility: Cantonspital Aarau
city: Zuerich
country: Switzerland
facility: University Hospital Zurich
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
city: Adana
country: Turkey
facility: Adana City Hospital
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Oncology Training and Research Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Oncology Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Medical Faculty Capa Hospital
city: Izmir
country: Turkey
facility: Ege University Tulay Aktas Oncology Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: The Royal Marsden Hospital, Chelsea
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital, Sutton
Study officials:
References: