Recurrent/Metastatic Head and Neck Carcinoma
Conditions
Interventions
Drug: Dostarlimab
Dostarlimab will be administered.
Drug: Belrestotug
Belrestotug will be administered.
Drug: GSK6097608
GSK6097608 will be administered.
Drug: GSK4381562
GSK43815628 will be admini
Sponsors
Ishibashi Hideyasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participants provide signed informed consentmust and are >-18 years of age at the time of signing the ICF. -Have histologically or cytologically-confirmed R/M HNSCC that is considered incurable by local therapies (the eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.). -Has measurable (target) disease based on RECIST 1.1. -Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. -Provides a tumor tissue sample obtained Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of R/M HNSCC. -Has tumor PD-L1 expression as determined by the DAKO 22C3 assay. -If the primary tumor site is oropharyngeal carcinoma, the participant must have HPV results using a p16 histology assay. -Has adequate organ function. -If of childbearing potential, female participants must be willing to use adequate contraception.
Exclusion criteria
Exclusion criteria: -Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-1, PD-L1, CTLA-4, TIGIT, CD96, or other immune checkpoint pathways. -Participants with previous malignancies unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period. -Has had major surgery within 4 weeks of the first dose of study intervention. -Have active tumor bleeding or a high risk of bleeding. -Has PD within 4 months of completion of curatively intended treatment for locoregionally advanced HNSCC. -Participants with any carcinomatous meningitis or leptomeningeal spread and those with uncontrolled or symptomatic CNS metastases. -Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years. -Has symptomatic ascites or pleural effusion. -History or evidence of cardiovascular risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the antitumor activity of novel immunotherapy combinations compared with dostarlimab in participants with PD-L1 positive R/M HNSCC | — |
Secondary
| Measure | Time frame |
|---|---|
| -To further assess the clinical activity of novel immunotherapy combinations compared with dostarlimab in participants with PD-L1 positive R/M HNSCC. -To assess the ctDNA-based response rate in novel immunotherapy combinations. -To assess the additive benefit of the triplet combination regimen in comparison to the doublet combination regimens. -To further characterize the safety of novel immunotherapy combinations. -To determine the immunogenicity of individual agents comprising novel immunotherapy combinations. -To characterize the PK properties of novel immunotherapy combinations. -To assess the relationship between ctDNA-based response with clinical activity parameters in novel immunotherapy combinations. | — |
Countries
Argentina, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Norway, Poland, Portugal, Romania, Spain, Sweden, Taiwan, Turkiye, United States
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline K.K.
Outcome results
None listed