This phase 1/2 nonrandomized clinical trial found the combination of PDS0101, PDS01ADC, and BA has an acceptable safety profile and showed promising clinical activity and OS outcomes in patients with advanced HPV-16–positive cancers, either ICB naive or ICB resistant, supporting further investigation of PDS0101, PDS01ADC, and simultaneous PD-L1 and TGF-β inhibition in this patient population. This evidence concerns the gene TGFB1 and cancer.