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
Condition(s) studied
Investigational drug(s) / intervention(s)
BI 770371: BI 770371
Pembrolizumab: Pembrolizumab
Cetuximab: Cetuximab
Study 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
Primary outcome measure(s)
- 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.
Trial sites (51)
| Facility | City | Region | Status |
|---|---|---|---|
| Norton Cancer Institute, Downtown | Louisville | Kentucky | |
| M Health Fairview Clinics and Surgery Center - Minneapolis | Minneapolis | Minnesota | |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | |
| Gosford Hospital | Gosford | New South Wales | |
| Andrew Love Cancer Centre | Geelong | Victoria | |
| Hospital de Amor | Barretos | Brazil | |
| Liga Norte Riograndense contra o cancer | Natal | Brazil | |
| Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto | São José do Rio Preto | Brazil | |
| MBAL Sveta Sofia | Sofia | Bulgaria | |
| CTR Oscar Lambret | Lille | France | |
| CTR Leon Berard | Lyon | France | |
| HOP Timone | Marseille | France | |
| Institut 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 | |
| Clinexpert Gyongyos | Gyöngyös | Hungary | |
| Istituto Scientifico Romagnolo | Meldola (FC) | 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 | |
| Unidad Clinica Farmacologica Bioemagno | Mexico City | Mexico | |
| Centro Oncologico Personalizado | México | Mexico | |
| Instituto Nacional de Cancerologia | México | Mexico | |
| Centro Oncológico Internacional | Tlajomulco de Zuñiga | Mexico | |
| ARENSIA Exploratory Medicine | Chisinau | Moldova | |
| 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 | |
| Severance Hospital | Seoul | South Korea | |
| Samsung Medical Center | Seoul | South Korea | |
| The Catholic University of Korea, St.Vincent's Hospital | Suwon | South Korea | |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | |
| Cantonspital Aarau | Aarau | Switzerland |
+ 11 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Boehringer Ingelheim trials in Turkey
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06806852 on ClinicalTrials.gov ↗ ← All trials in Turkey