Advanced Cutaneous MelanomaPhase 1NCT07628894
Circadian-Optimized Light Therapy for the Treatment of Patients With Advanced Melanoma Receiving Tumor-Infiltrating Lymphocyte Therapy
A Phase 1 study testing Biospecimen Collection, Internet-Based Intervention and Medical Device Usage and Evaluation in people with Advanced Cutaneous Melanoma and Clinical Stage III Cutaneous Melanoma AJCC v8, run by City of Hope Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cutaneous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
- What is being tested?
- Biospecimen Collection, Internet-Based Intervention and Medical Device Usage and Evaluation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2026to 5 Jul 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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])
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
Kelly Mahuron, kmahuron@coh.org
Kelly Mahuron
About this study
Official title: A Single-Center, Prospective Pilot Trial of Circadian-Optimized Light Therapy (COLT) in Patients Undergoing Tumor-Infiltrating Lymphocyte (TIL) Therapy for Metastatic Melanoma
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the feasibility of COLT with TIL therapy.
SECONDARY OBJECTIVES:
- Evaluate the safety of COLT with TIL therapy. II. Evaluate the acceptability of COLT intervention to patients. III. Evaluate the effect of COLT on patient-reported quality of life metrics.
EXPLORATORY OBJECTIVES:
- Evaluate changes that occur in patient circadian clocks with COLT during TIL therapy using actigraphy and circadian clock gene analysis.
II. Evaluate the alterations and time course that occur in tumor immune cell subsets and phenotype with COLT during TIL therapy.
III. Evaluate the toxicities related to TIL therapy (i.e., cytopenia, interleukin 2 [IL-2] toxicity) that occur with COLT during TIL therapy.
OUTLINE:
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.
After completion of study intervention, patients are followed up at 30 days.
- Conditions
- Advanced Cutaneous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma
- Being tested
- Biospecimen Collection, Internet-Based Intervention, Medical Device Usage and Evaluation, Phototherapy, Questionnaire Administration
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Internet-Based InterventionOther
Receive access to Circadian OS application
Medical Device Usage and EvaluationOther
Wear wrist actigraphy
PhototherapyProcedure or surgery
Also called Actinotherapy, Bright Light Therapy, light therapy
Undergo light therapy sessions
Questionnaire AdministrationOther
Ancillary studies
Therapeutic Tumor Infiltrating LymphocytesBiological
Also called Tumor Infiltrating Lymphocytes
Given infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment (COLT, TIL) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Other: Internet-Based Intervention; Other: Medical Device Usage and Evaluation; Procedure: Phototherapy; Other: Questionnaire Administration; Biological: Therapeutic Tumor Infiltrating Lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
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.
Measured: From the start of intervention through the end of the intervention period, assessed up to day 90
Secondary outcomes (5)
Incidence, severity, and attribution of COLT-related treatment-emergent adverse events
Will be graded by Common Terminology Criteria for Adverse Events version 5.0.
Measured: From the first day of COLT administration through 30 days after completion of intervention
Patient-reported acceptability and usability of COLT
Will be assessed using the Acceptability of Intervention Measure questionnaire. Responses will be summarized as total and subscale scores with means, standard deviations, medians, and ranges. The proportion of participants meeting a predefined threshold for acceptability or usability on the instrument's scale will also be reported with exact 95 percent confidence intervals.
Measured: Up to day 90
Patient scores for quality of life and symptom burden
Will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care. Data will be evaluated for functional scale, global health status, and symptoms. Scores will be summarized descriptively and compared across study phases.
Measured: Up to day 90
Patient scores for fatigue
Will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue questionnaire. Data will be evaluated for functional scale, global health status, and symptoms. Scores will be summarized descriptively and compared across study phases.
Measured: Up to day 28
Patient scores for depression
Will be evaluated using PROMIS Depression questionnaire. Data will be evaluated for functional scale, global health status, and symptoms. Scores will be summarized descriptively and compared across study phases.
Measured: Up to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start23 Dec 2026 (estimated)
- Primary completion5 Jul 2027 (estimated)
- Study completion5 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Cutaneous MelanomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kelly Mahuron, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628894
- Sponsor's protocol ID
- 25102
- Other IDs
- NCI-2026-03733, 25102, P30CA033572
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No