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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

NCT06806852 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-05-20

No results posted yet for this 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.

Conditions

Interventions

DRUG

BI 770371

BI 770371

DRUG

Pembrolizumab

Pembrolizumab

DRUG

Cetuximab

Cetuximab

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-14
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Bulgaria
  • France
  • Georgia
  • Germany
  • Hungary
  • Italy
  • Japan
  • Mexico
  • Moldova
  • Poland
  • Romania
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06806852 on ClinicalTrials.gov