MedTrace Logo

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

NCT07538479 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-20

No results posted yet for this study

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 20°C exposure for 8 hours on Day -2 and approximately 18°C exposure for 10 hours on Day -1. The first combination cycle begins on Day 1 concurrently with PD-1/PD-L1-based treatment, with exposure to an 18°C temperature-controlled hospital room for 12 hours per day for 7 consecutive days. If tolerated, cold exposure may be repeated in subsequent PD-1/PD-L1 treatment cycles. The primary objective is to evaluate safety, tolerability, and feasibility. Secondary objectives are to explore preliminary antitumor activity and the effects on brown adipose tissue activation, peripheral immune profiling, circulating cytokines, metabolomics, gut microbiota, patient-reported outcomes, and tumor immune/metabolic biomarkers when paired tumor tissue is available.

Conditions

  • Solid Tumors
  • Solid Malignancies
  • Cold Exposure
  • Immunotherapy

Interventions

OTHER

Controlled Cold Exposure

Controlled environmental cold exposure in a temperature-controlled hospital room. Cold acclimation includes approximately 20°C for 8 hours on Day -2 and approximately 18°C for 10 hours on Day -1; formal intervention consists of 18°C exposure for 12 hours per day for 7 consecutive days and may be repeated in later cycles if tolerated.

DRUG

Investigator-Selected Standard PD-1/PD-L1 Inhibitor-Based Therapy

Standard PD-1/PD-L1 inhibitor monotherapy or PD-1/PD-L1 inhibitor-containing standard combination therapy selected according to tumor type, clinical guidelines, and routine clinical practice.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2027-07-31
Completion
2029-06-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07538479 on ClinicalTrials.gov