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Circadian-Optimized Light Therapy for Advanced Melanoma

This study is testing a new approach called Circadian-Optimized Light Therapy (COLT) alongside standard tumor-infiltrating lymphocyte (TIL) therapy (lifileucel/Amtagvi) for people with advanced melanoma. Advanced melanoma is a type of skin cancer that has spread. COLT uses morning light exposure to help regulate your body's natural 24-hour clock, which can be disrupted in cancer patients. The study aims to see if COLT is practical and safe to use with TIL therapy, and if it improves your quality of life. You may be eligible if you are 18 or older, have advanced melanoma that has progressed after immune checkpoint inhibitor therapy, and are eligible for TIL therapy. The study will assess how well participants stick to the light therapy.

Study design
This interventional study is testing a new treatment approach in a small group of 8 participants. It is not specified if this is a randomized or blinded study.
What's involved
You would receive access to a special app, undergo daily light therapy sessions for about an hour each morning, and wear a wrist device continuously. You will also have blood samples collected throughout the study.
Compensation
Not stated in the trial record.
Follow-up
You may continue the light therapy for up to 90 days after TIL infusion, and adherence will be assessed up to day 90.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07628894

Circadian-Optimized Light Therapy for the Treatment of Patients With Advanced Melanoma Receiving Tumor-Infiltrating Lymphocyte Therapy

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~8 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:Biospecimen CollectionInternet-Based InterventionMedical Device Usage and EvaluationPhototherapyQuestionnaire AdministrationTherapeutic Tumor Infiltrating Lymphocytes

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adherence
Measured over From the start of intervention through the end of the intervention period, assessed up to day 90

Conditions

Advanced Cutaneous Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Cutaneous Melanoma

Explore related trials

Melanoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Kelly Mahuron · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Kelly Mahuron
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 \[SOP\])

Exclusion

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)

What this trial measures

  • AdherenceFrom the start of intervention through the end of the intervention period, assessed up to day 90

    Will be measured as the proportion of prescribed daily Circadian-Optimized Light Therapy (COLT) sessions attempted by each participant. Session initiation, duration, and completion will be automatically recorded by the Circadian OS application and verified at scheduled study visits. Participants who attempt at least 50% of sessions will be considered adherent. Adherence data will be summarized descriptively, including the median and range of completion rates across participants. Will be reported with a two-sided 95% exact (Clopper-Pearson) confidence interval.