A Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck- GALAXIES H&N-202
Categories (click each to see list of all clinical trials associated with that category): Head & Neck (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Abughanimeh, Omar
Contact Information:
Kimberly Shields
kimberly.shields@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06062420?term=NCT06062420&rank=1&tab=table#recruitment-information
Summary
Primary
To evaluate the antitumor activity of novel immunotherapy combinations compared with dostarlimab in participants with PD-L1 positive R/M HNSCC
Secondary
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 evaluate the antitumor activity of novel immunotherapy combinations via treatment arm comparisons to assess the additive benefit of the triplet combination regimen (Substudy 3) in comparison to the doublet combination regimens (Substudies 1 and 2)
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
Tertiary/Exploratory/Other
To further evaluate the antitumor activity of novel immunotherapy combinations
To evaluate disease-related symptoms and treatment tolerability as reported by study participants.
To evaluate other measures of antitumor activity
To explore the relationship between PK parameters and antitumor activity, pharmacodynamics, safety endpoints, and other participant characteristics
To explore the association of baseline ctDNA features and clinical activity
To explore the correlation of additional baseline biomarkers in tumor and/or blood to clinical activity
To evaluate the pharmacodynamic effects of experimental treatment regimens Pharmacogenetics: To investigate the relationship between genetic variations in germline DNA and response to therapy