Actively Recruiting
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
Led by Boehringer Ingelheim · Updated on 2026-05-12
90
Participants Needed
52
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with confirmed metastatic or recurrent head and neck squamous cell carcinoma in the oral cavity, oropharynx, hypopharynx, or larynx not suitable for curative local treatment
- Willingness to provide a pretreatment biopsy or tumor tissue sample
- No prior systemic treatment for metastatic or recurrent disease; prior systemic therapy completed over 6 months ago for locally advanced disease is allowed
- No contraindications to pembrolizumab monotherapy per local guidelines
- No contraindications to cetuximab per local guidelines
- At least one measurable tumor lesion outside the central nervous system
- Additional inclusion criteria may apply
You will not qualify if you...
- Nasopharyngeal carcinoma, tumors in nasal cavity or paranasal sinuses, or cancer of unknown primary
- Tumors requiring urgent treatment like palliative care, surgery, or radiation
- Disease progression within 6 months of completing systemic therapy for locally advanced disease
- Current treatment for brain metastases or leptomeningeal disease
- Patients for whom pembrolizumab alone is not the preferred treatment
- Prior treatment with anti-SIRPα or anti-CD47 agents
- Prior treatment with anti-PD-1, anti-PD-L1, or other similar immune therapies
- Prior allogeneic stem cell or organ transplant
- Additional exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
Norton Cancer Institute, Downtown
Louisville, Kentucky, United States, 40202
Actively Recruiting
2
M Health Fairview Clinics and Surgery Center - Minneapolis
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
3
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
4
Gosford Hospital
Gosford, New South Wales, Australia, 2250
Actively Recruiting
5
Andrew Love Cancer Centre
Geelong, Victoria, Australia, 3220
Actively Recruiting
6
Hospital de Amor
Barretos, Brazil, 14784-400
Active, Not Recruiting
7
Liga Norte Riograndense contra o cancer
Natal, Brazil, 59062-000
Completed
8
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, Brazil, 15090-000
Active, Not Recruiting
9
MBAL Sveta Sofia
Sofia, Bulgaria, 1404
Not Yet Recruiting
10
CTR Oscar Lambret
Lille, France, 59020
Actively Recruiting
11
CTR Leon Berard
Lyon, France, 69373
Actively Recruiting
12
HOP Timone
Marseille, France, 13385
Not Yet Recruiting
13
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
14
ARENSIA Exploratory Medicine LLC
Tbilisi, Georgia, 0112
Actively Recruiting
15
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany, 38114
Actively Recruiting
16
Universitätsklinikum Jena
Jena, Germany, 07743
Completed
17
Universität Leipzig
Leipzig, Germany, 04103
Completed
18
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
19
Semmelweis University
Budapest, Hungary, 1083
Not Yet Recruiting
20
Clinexpert Gyongyos
Gyöngyös, Hungary, 3200
Actively Recruiting
21
Istituto Scientifico Romagnolo
Meldola (FC), Italy, 47014
Completed
22
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37126
Completed
23
Hokkaido University Hospital
Hokkaido, Sapporo, Japan, 060-8648
Not Yet Recruiting
24
Kobe University Hospital
Hyogo, Kobe, Japan, 650-0017
Actively Recruiting
25
Kansai Medical University Hospital
Osaka, Hirakata, Japan, 573-1191
Actively Recruiting
26
Shizuoka Cancer Center
Shizuoka, Sunto-gun, Japan, 411-8777
Actively Recruiting
27
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, Japan, 135-8550
Actively Recruiting
28
Unidad Clinica Farmacologica Bioemagno
Mexico City, Mexico, 04660
Not Yet Recruiting
29
Instituto Nacional de Cancerologia
México, Mexico, 14080
Actively Recruiting
30
Centro Oncológico Internacional
Tlajomulco de Zuñiga, Mexico, 45640
Not Yet Recruiting
31
ARENSIA Exploratory Medicine
Chisinau, Moldova, MD-2025
Actively Recruiting
32
Center of Oncology of the Lublin Region St. Jana z Dukli
Lublin, Poland, 20090
Not Yet Recruiting
33
"Prof. Dr. Alexandru Trestioreanu" Oncology Institut
Bucharest, Romania, 022328
Actively Recruiting
34
National University Hospital-Singapore-22806
Singapore, Singapore, 119228
Actively Recruiting
35
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
36
Samsung Medical Center
Seoul, South Korea, 135-710
Actively Recruiting
37
The Catholic University of Korea, St.Vincent's Hospital
Suwon, South Korea, 16247
Not Yet Recruiting
38
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
39
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Not Yet Recruiting
40
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Not Yet Recruiting
41
Cantonspital Aarau
Aarau, Switzerland, 5001
Not Yet Recruiting
42
National Taiwan University Hospital
Taipei, Taiwan, 10048
Actively Recruiting
43
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
44
Siriraj Hospital
Bangkoknoi, Thailand, 10700
Actively Recruiting
45
Adana City Hospital
Adana, Turkey (Türkiye), 01220
Actively Recruiting
46
Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Turkey (Türkiye), 06200
Actively Recruiting
47
Hacettepe University Oncology Hospital
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
48
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye), 06800
Not Yet Recruiting
49
Istanbul University Medical Faculty Capa Hospital
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
50
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Active, Not Recruiting
51
The Royal Marsden Hospital, Chelsea
London, United Kingdom, SW3 6JJ
Not Yet Recruiting
52
The Royal Marsden Hospital, Sutton
Sutton, United Kingdom, SM2 5PT
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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