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

NCT07628894 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 25102NCI-2026-03733P30CA033572
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From the first day of COLT administration through 30 days after completion of intervention

• Patient-reported acceptability and usability of COLT

  Up to day 90

• Patient scores for quality of life and symptom burden

  Up to day 90

• Patient scores for fatigue

  Up to day 28

• Patient scores for depression

  Up to day 90

Study Arms (1)

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.

Procedure: Biospecimen Collection; Other: Internet-Based Intervention; Other: Medical Device Usage and Evaluation; Procedure: Phototherapy; Other: Questionnaire Administration; Biological: Therapeutic Tumor Infiltrating Lymphocytes

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Treatment (COLT, TIL)

Internet-Based Intervention OTHER

Receive access to Circadian OS application

Treatment (COLT, TIL)

Medical Device Usage and Evaluation OTHER

Wear wrist actigraphy

Treatment (COLT, TIL)

Phototherapy PROCEDURE

Undergo light therapy sessions

Also known as: Actinotherapy, Bright Light Therapy, light therapy

Treatment (COLT, TIL)

Questionnaire Administration OTHER

Ancillary studies

Treatment (COLT, TIL)

Therapeutic Tumor Infiltrating Lymphocytes BIOLOGICAL

Given infusion

Also known as: Tumor Infiltrating Lymphocytes

Treatment (COLT, TIL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[SOP\])

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Specimen Handling; Phototherapy; Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Therapeutics

Study Officials

• Kelly Mahuron

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): December 23, 2026
• Primary Completion (Estimated): July 5, 2027
• Study Completion (Estimated): July 5, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

US (1)