Phase 1 study of BAY1905254 - An early clinical research study to evaluate a new drug called Bapotulimab (BAY1905254) in the expansion cohort in combination with Pembolizumab in Head and Neck cancer that has returned or is discovered to be metastatic and is expressing PDL1.

  • sponsor
    Bayer HealthCare
Updated on 14 September 2021
squamous cell carcinoma
primary tumor
metastatic head and neck cancer
metastatic head and neck squamous cell carcinoma


This study is being done to learn more about a new drug called Bapotulimab given in combination with Pembrolizumab.  The purpose of this study is to learn if this new combination of drugs is safe for the participants, how it affects the body and to try to find the best dose of the new drug to give to participants and to obtain a preliminary assessment of the tumor response efficacy in the recurrent or metastatic Head and Neck Cancer.


For additional information:

Condition Pembrolizumab, Immunotherapy, Head and Neck Cancer, HNSCC, PD1, Immune checkpoint inhibitor, Bapotulimab, PDL1, ILDR2, head and neck cancer, Oncology, Head and Neck Cancer
Clinical Study IdentifierTX276581
SponsorBayer HealthCare
Last Modified on14 September 2021


Yes No Not Sure

Inclusion Criteria

Patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma considered incurable by local therapies and eligible to receive anti-PD(L)1 as first-line treatment (PD-L1 positive with Combined Positive Score [CPS] ≥1 as evaluated in pre-screening)
Primary tumor locations: oropharynx, oral cavity, hypopharynx, or larynx (nasopharynx (any histology) is not allowed)
No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy completed > 6 m prior if given as part of multimodal treatment for locally advanced disease)
No prior treatment with immune checkpoint inhibitors
Can provide archival tumor tissue not older than 3 months from a core or excisional biopsy (fine needle aspirate is not sufficient) for PD-L1 pre-screening using the PD-L1 IHC 22C3 pharmDx assay
Instead of de novo analysis, available data for PD-L1 expression using CPS assessment in this assay can be accepted after discussion with and approval by the sponsor

Exclusion Criteria

Progressive disease within six months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC
History of severe immune related adverse effects from prior immunotherapy, except hypothyroidism clinically stable on hormone replacement treatment and controlled type 1 diabetes
Grade ≥ 3 infections within 4 weeks before the first study drug administration
Clinically active infections > Grade 1 within 2 weeks before the first study drug administration
Previous or active myocarditis/myositis in history (independent of cause)
History of cardiac disease as defined in the protocol
Pneumonitis, idiopathic pulmonary fibrosis, organizing, interstitial lung disease
Active or history of autoimmune disease
Known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Treatment with systemic immunosuppressant medications within 2 weeks before the first study drug administration
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note