Phase 1 Study of Controlled Cold Exposure with PD-1PD-L1 Immunotherapy in Adults with Solid Tumors

What this Trial Is About

Researchers are exploring the safety, feasibility, and initial effectiveness of combining controlled cold exposure with standard PD-1PD-L1 immunotherapy for adults with solid tumors. This phase I, single-center, open-label study plans to include 24 participants receiving standard immunotherapy either alone or in combination, according to routine clinical practice. The study aims to assess how cold exposure influences immune responses, tumor biomarkers, and patient outcomes alongside immunotherapy. Participants will undergo a 2-day cold acclimation before starting the combined treatment, with temperature-controlled exposure at approximately 20B0C on Day -2 and 18B0C on Day -1. From Day 1, participants will be exposed daily to 18B0C for 12 hours over 7 consecutive days while receiving their immunotherapy. If well tolerated, this cold exposure may be repeated during subsequent treatment cycles. Standard immunotherapy regimens are selected based on tumor type and clinical guidelines. During the study, researchers will monitor safety, tolerability, and adherence to the cold exposure protocol, recording adverse events from the start of the intervention until 30 days after treatment ends. They will also evaluate tumor response through imaging performed every 6-12 weeks for up to a year, and assess survival outcomes for up to 36 months. Additional assessments include immune profiling, metabolomics, gut microbiota analysis, patient-reported outcomes, and biomarker studies on tumor tissue when available. The total duration of participant involvement depends on treatment response and follow-up schedules.

Controlled Cold Exposure Combined With PD-1/PD-L1 Immunotherapy in Solid Tumors (NIVALIS)