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.

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

Summary

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.

Description

For additional information: clinicaltrials.gov/ct2/show/NCT03666273

Details
Condition head and neck cancer, Oncology
Clinical Study IdentifierTX276581
SponsorBayer HealthCare
Last Modified on14 September 2021

Eligibility

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
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