Nivolumab + cabozantinib shows feasible safety and prolonged disease stabilization in a small HIV-positive solid-tumor cohort

Nivolumab is a PD-1 immune checkpoint inhibitor and cabozantinib is a multi-kinase TKI (including VEGFR2/MET/AXL) with putative myeloid/TME-modulating effects; this multicenter Phase 1 pilot enrolled people with HIV (PWH) on stable ART with advanced solid tumors (NCT04514484). Between November 2021 and January 2024, 8 were enrolled and 7 treated (Kaposi sarcoma n=5; chondrosarcoma n=1; prostate cancer n=1); among 6 response-evaluable patients, best response was stable disease in 5, including >12-month disease stabilization in 3 heavily pretreated patients, with no dose-limiting toxicities, infrequent grade 3 TRAEs, and no grade 4/5 TRAEs; HIV viral load and CD4 counts remained stable on therapy. Efficacy is hard to benchmark given the tiny, heterogeneous cohort and “SD-only” responses, but in HIV-associated KS, single-agent PD-1 blockade has reported objective responses in prospective data (e.g., pembrolizumab ORR ~62% in a KS cohort), so this pilot’s signal looks more like disease control than clear additive tumor shrinkage.