NCT07628894Not yet recruitingPhase 1
Circadian-Optimized Light Therapy for the Treatment of Patients With Advanced Melanoma Receiving Tumor-Infiltrating Lymphocyte Therapy
A Single-Center, Prospective Pilot Trial of Circadian-Optimized Light Therapy (COLT) in Patients Undergoing Tumor-Infiltrating Lymphocyte (TIL) Therapy for Metastatic Melanoma
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 1 Jun 2026
- Start date
- 23 Dec 2026
- Primary completion date
- 5 Jul 2027
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Melanoma
- NCT number
- NCT07628894
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 8
- From 23 Dec 2026 to the primary completion date, 5 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment
Other illness
- 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
Other
- Explicit Munich Chronotype Questionnaire (MCTQ) cutoffs (\< 2:00, \> 5:00)
- 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
- 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)
Who the study is looking for
- 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 \[SOP\])
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.