Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cutaneous Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Clinical Stage III Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage IV Cutaneous Melanoma AJCC v8 | — | UNRESOLVED | — |
| Metastatic Cutaneous Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Internet-Based Intervention | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Other | — | UNRESOLVED |
| Phototherapy | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Therapeutic Tumor Infiltrating Lymphocytes | Biological | Therapeutic Tumor Infiltrating Lymphocytes | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (COLT, TIL)
- description
- Starting on day -14, patients receive access to the Circadian OS application and within the first hour of waking up undergo light therapy sessions over 1 hour daily between 8:00 and 10:00 am for up to 28 days after TIL in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care TIL infusion on day 0. Patients may optionally continue COLT for up to 90 days post TIL infusion. Patients also wear wrist actigraphy continuously to monitor sleep-wake cycles, light exposure, and circadian rhythms during TIL therapy. Additionally, patients undergo blood sample collection throughout the study.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Internet-Based Intervention
- Other: Medical Device Usage and Evaluation
- Procedure: Phototherapy
- Other: Questionnaire Administration
- Biological: Therapeutic Tumor Infiltrating Lymphocytes
Primary outcomes (1)
- measure
- Adherence
- timeFrame
- From the start of intervention through the end of the intervention period, assessed up to day 90
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 (including compliance issues related to feasibility/logistics)
References
Publications (0)
Data not yet available