Head and Neck Squamous Cell CarcinomaPhase 1NCT06806852
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
A Phase 1 study testing BI 770371, Pembrolizumab and Cetuximab in people with Head and Neck Squamous Cell Carcinoma, run by Boehringer Ingelheim at 51 sites in 22 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- BI 770371, Pembrolizumab and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 51 sitesin 22 countries
- Study dates
- 14 May 2025to 31 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
51 sites in 22 countries.
51 sites in 22 countries
Japan5 sites
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Kobe University Hospital
Hyogo, Kobe, 650-0017
Kansai Medical University Hospital
Osaka, Hirakata, 573-1191
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Turkey (Türkiye)5 sites
Adana City Hospital
Adana, 01220
Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200
Hacettepe University Oncology Hospital
Ankara, 06230
Ankara Bilkent City Hospital
Ankara, 06800
Istanbul University Medical Faculty Capa Hospital
Istanbul, 34093
France4 sites
CTR Oscar Lambret
Lille, 59020
CTR Leon Berard
Lyon, 69373
HOP Timone
Marseille, 13385
Institut Gustave Roussy
Villejuif, 94805
Germany4 sites
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, 38114
Universitätsklinikum Jena
Jena, 07743
Universität Leipzig
Leipzig, 04103
Universitätsklinikum Ulm
Ulm, 89081
Mexico4 sites
Centro Oncologico Personalizado
México, 06760
Instituto Nacional de Cancerologia
México, 14080
Unidad Clinica Farmacologica Bioemagno
Mexico City, 04660
Centro Oncológico Internacional
Tlajomulco de Zuñiga, 45640
United States3 sites
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Norton Cancer Institute, Downtown
Louisville, Kentucky, 40202
M Health Fairview Clinics and Surgery Center - Minneapolis
Minneapolis, Minnesota, 55455
Brazil3 sites
Hospital de Amor
Barretos, 14784-400
Liga Norte Riograndense contra o cancer
Natal, 59062-000
Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
South Korea3 sites
Severance Hospital
Seoul, 03722
Samsung Medical Center
Seoul, 135-710
The Catholic University of Korea, St.Vincent's Hospital
Suwon, 16247
United Kingdom3 sites
St Bartholomew's Hospital
London, EC1A 7BE
The Royal Marsden Hospital, Chelsea
London, SW3 6JJ
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT
Australia2 sites
Andrew Love Cancer Centre
Geelong, Victoria, 3220
Gosford Hospital
Gosford, New South Wales, 2250
Hungary2 sites
Semmelweis University
Budapest, 1083
Clinexpert Gyongyos
Gyöngyös, 3200
Italy2 sites
Istituto Scientifico Romagnolo
Meldola (FC), 47014
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Taiwan2 sites
National Taiwan University Hospital
Taipei, 10048
Taipei Veterans General Hospital
Taipei, 11217
Poland1 site
Center of Oncology of the Lublin Region St. Jana z Dukli
Lublin, 20090
Romania1 site
"Prof. Dr. Alexandru Trestioreanu" Oncology Institut
Bucharest, 022328
Singapore1 site
National University Hospital-Singapore-22806
Singapore, 119228
About this study
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)
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.
Read more
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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- BI 770371, Pembrolizumab, Cetuximab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 770371Drug
BI 770371
PembrolizumabDrug
Pembrolizumab
CetuximabDrug
Cetuximab
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab | Experimental | Not described Receives: Drug: Pembrolizumab |
| Pembrolizumab + BI 770371 | Experimental | Not described Receives: Drug: BI 770371; Drug: Pembrolizumab |
| Pembrolizumab + BI 770371 + Cetuximab | Experimental | Not described Receives: Drug: BI 770371; Drug: Pembrolizumab; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response (OR) with confirmation
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.
Measured: Up to 27 months
Secondary outcomes (7)
Occurrence of treatment related adverse event (AE) from first treatment administration until the earliest of 90 days after the last dose, death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent
Measured: Up to 27 months
Occurrence of treatment related AE leading to treatment discontinuation from first treatment administration until the earliest of 90 days after the last dose, death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent
Measured: Up to 27 months
Overall survival (OS)
OS defined as the time from first treatment administration until death from any cause.
Measured: Up to 27 months
Overall survival at 6 and 12 months (OS6 and OS12)
OS defined as being alive at 6 months or at 12 months from first treatment administration.
Measured: At 6 months and 12 months
Progression-free survival (PFS)
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.
Measured: Up to 27 months
Progression-free survival at 6 months (PFS6)
PFS defined as being alive and without progression at 6 months from first treatment administration.
Measured: At 6 months
Duration of objective response (DOR)
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.
Measured: Up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start14 May 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806852
- Sponsor's protocol ID
- 1501-0002
- Other IDs
- 2024-517091-38-00, U1111-1312-0435
- Status last verified
- Oct 2026
- First submitted
- 28 Jan 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06806852
- Acronym / sponsor ID
- 1501-0002
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab | Experimental | Drug: Pembrolizumab |
| Pembrolizumab + BI 770371 | Experimental | Drug: BI 770371, Drug: Pembrolizumab |
| Pembrolizumab + BI 770371 + Cetuximab | Experimental | Drug: BI 770371, Drug: Pembrolizumab, Drug: Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 770371BI 770371 | Drug | Pembrolizumab + BI 770371, Pembrolizumab + BI 770371 + Cetuximab |
| PembrolizumabPembrolizumab | Drug | Pembrolizumab, Pembrolizumab + BI 770371, Pembrolizumab + BI 770371 + Cetuximab |
| CetuximabCetuximab | Drug | Pembrolizumab + BI 770371 + Cetuximab |
Primary outcome
Objective response (OR) with confirmation
Time frame: 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.
7 secondary outcomes
Occurrence of treatment related adverse event (AE) from first treatment administration until the earliest of 90 days after the last dose, death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent
Time frame: Up to 27 months
Occurrence of treatment related AE leading to treatment discontinuation from first treatment administration until the earliest of 90 days after the last dose, death, subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent
Time frame: Up to 27 months
Overall survival (OS)
Time frame: Up to 27 months
Overall survival at 6 and 12 months (OS6 and OS12)
Time frame: At 6 months and 12 months
Progression-free survival (PFS)
Time frame: Up to 27 months
Progression-free survival at 6 months (PFS6)
Time frame: At 6 months
Duration of objective response (DOR)
Time frame: Up to 27 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 770371, Pembrolizumab and Cetuximab in people with Head and Neck Squamous Cell Carcinoma, run by Boehringer Ingelheim at 51 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Japan, Turkey (Türkiye), France, Germany, Mexico and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response (OR) with confirmation (time frame: Up to 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.