OncoMatch/Clinical Trials/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
Is NCT06806852 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BI 770371 and Pembrolizumab for head and neck squamous cell carcinoma.
Treatment: BI 770371 · Pembrolizumab · Cetuximab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Metastatic disease required
Presence of at least one measurable non-central nervous system (CNS) lesion (according to RECIST v1.1.)
Prior therapy
Cannot have received: anti-PD-1 therapy
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.
Cannot have received: anti-PD-L1 therapy
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.
Cannot have received: checkpoint inhibitor
agent directed to another stimulatory or co-inhibitory Tcell receptor (e.g. CTLA-4, OX 40, CD137)
Cannot have received: anti-SIRPα or anti-CD47 agent
Prior treatment with any anti signal regulatory protein alpha (SIRPα) or anti-integrin-associated protein (CD47) agent, regardless of treatment intent.
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell or solid organ transplantation.
Cannot have received: solid organ transplant
Prior allogeneic stem cell or solid organ transplantation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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