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Testing BI 765179 alone and in combination with ezabenlimab in advanced cancer (solid tumors) and BI 765179 in combination with pembrolizumab in advanced head and neck cancer

This study is being done to see if the study drug, called BI 765179, in combination with another drug called pembrolizumab, can help people with advanced head and neck cancer.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will meet with the study team to determine if you are eligible for the study. You will have an exam, labs, and imaging. If you are eligible, you will be assigned to receive one of the two drug cohorts. You will receive your study drug and pembrolizumab in the hospital. After you stop receiving the study drugs, you will need to return to clinic for follow up visits. Once these visits are completed, you will be contacted by phone to assess your condition.

In-person visits:
34+, depending on how long you take the study drugs

Phone or online visits:
Survival follow up visits may be completed by phone

Total length of participation:
27 months, possibly more for follow up and if you continue taking the study drug

Looking for Specific Volunteers

Able to participate:

Have metastatic or incurable, recurrent head and neck cancer
No prior therapy for metastatic or incurable, recurrent disease
Tumor has PD-L1
Archived tissue or willing to have a biopsy
Adequate lab values per protocol

Not eligible if:

Disease can be treated with local therapy
Previous treatment with drugs that target CD137 and/or PD-(L)1
Active infection requiring treatment
Have HIV and meet criteria in protocol

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Comprehensive Cancer Center
cancerclinicaltrials@med.unc.edu

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Sumita Trivedi
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Head and Neck)

IRB Number

24-2837

ClinicalTrials.gov

NCT04958239

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Questions?

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