Circadian-Optimized Light Therapy for the Treatment of Patients With Advanced Melanoma Receiving Tumor-Infiltrating Lymphocyte Therapy
Starting soon · Phase 1
Conditions studied: Advanced Cutaneous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma
In brief
This phase I trial tests the effect of Circadian-Optimized Light Therapy (COLT) in conjunction with standard of care tumor-infiltrating lymphocytes (TIL) therapy in treating patients with melanoma that may have spread from where it first started to nearby tissue, lymph nodes or distant parts of the body (advanced). Circadian rhythm is the body's natural 24 hour clock which helps keep the body operating on a healthy wake-sleep cycle. Exposure to morning light has been shown to have a positive impact. Patients with advanced cancers often experience circadian disruption, including exposure to hospital-related light, treatment side effects, and inflammation. TIL are made by collecting and growing specialized T cells (a type of white blood cell) from a patient's tumor and given back to the patient to help stimulate the immune system in different ways to stop tumor cells from growing. However, disruptions in the circadian rhythm may impact the effectiveness of TIL therapy. COLT is a home-based digital intervention that delivers circadian-effective morning light using the Circadian OS iPad application. Daily light exposure may help prevent circadian disruption and improve immune and inflammatory responses. Adding COLT sessions to standard of care therapy with TIL may be safe and tolerable in patients with advanced melanoma.
Key facts
- Study ID
- NCT07628894
- Run by
- City of Hope Medical Center
- People needed
- 8
- Starts
- 2026-12-23
- Expected to finish
- 2027-07-05
- Last updated by the study team
- 2026-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Documented informed consent of the participant and/or legally authorized representative
- Age: ≥ 18 years
- Ability to read and understand English for questionnaires
- Progression on or after immune checkpoint inhibitor therapy
- Deemed eligible and consented for standard-of-care TIL therapy (lifileucel/Amtagvi)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (typically required for TIL therapy; confirm with clinical standards of practice [SOP])
You may not qualify if…
- Explicit Munich Chronotype Questionnaire (MCTQ) cutoffs (< 2:00, > 5:00)
- Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment
- Night shift work within the past 30 days or expected during the intervention
- Travel across ≥ 2 time zones within the past 14 days
- Diagnosed or suspected untreated moderate to severe obstructive sleep apnea
- History of mania, hypomania, bipolar disorder, migraine (with or without photophobia), or active seizure disorder
- Active psychosis, suicidal ideation, or recent psychiatric hospitalization (< 3 months)
- Ocular conditions exacerbated by bright light exposure
- Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Where it is running
- City of Hope Medical Center — Duarte, California, United States
Full record on ClinicalTrials.gov
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