Not Yet RecruitingPhase 1

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

United States8 participantsStarted 2026-12-23

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is in Phase 1 and hasn't started recruiting yet — given that early timing, what would be the realistic wait before I could even be considered, and how does that fit with the urgency of my treatment plan?
2The trial is testing light therapy alongside tumor-infiltrating lymphocyte therapy — can you help me understand what TIL therapy involves and whether I would be a candidate for it, since the light therapy seems to be built around that treatment?
3Since the primary outcome being measured is 'adherence' rather than tumor response or survival, does that mean this Phase 1 study is mainly trying to figure out whether patients can stick to the light therapy routine, and what does that mean for what I'd personally gain by joining?
4What does circadian-optimized light therapy actually involve day-to-day — for example, would I need special equipment at home, follow a strict lighting schedule, or make other lifestyle changes that could be hard to manage during cancer treatment?
5Given that this study is Phase 1 and not yet recruiting, would you recommend I pursue standard treatment now and potentially revisit this trial later, or are there other active trials I should be looking at in the meantime?'?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adherence

Timeframe: From the start of intervention through the end of the intervention period, assessed up to day 90

Trial details

NCT IDNCT07628894

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-05

View on ClinicalTrials.gov More Advanced Cutaneous Melanoma trials