U.S., April 21 -- ClinicalTrials.gov registry received information related to the study (NCT07538479) titled 'Controlled Cold Exposure Combined With PD-1/PD-L1 Immunotherapy in Solid Tumors (NIVALIS)' on April 02.
Brief Summary: This is a single-center, prospective, single-arm, open-label phase I exploratory study that plans to enroll 24 participants with solid malignancies. All participants will receive controlled cold exposure in addition to standard PD-1/PD-L1 inhibitor monotherapy or PD-1/PD-L1 inhibitor-based standard combination therapy. A 2-day cold acclimation phase will precede formal intervention, consisting of approximately 20degC exposure for 8 hours on Day -2 and approximately 18degC exposure for 10 hours on Day -1. The first ...