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NCT07628894 · ClinicalTrials.gov registry record · Phase 1
Circadian-Optimized Light Therapy for the Treatment of Patients With Advanced Melanoma Receiving Tumor-Infiltrating Lymphocyte Therapy
A Phase 1 study, sponsored by City of Hope Medical Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT07628894: Clinical Trial Phase 1 study, sponsored by City of Hope Medical Center.
NCT07628894 is a Phase 1 study that has not yet begun recruiting, run by City of Hope Medical Center. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07628894, a Phase 1 study, has not yet begun recruiting, sponsored by City of Hope Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- OTHER Medical Device Usage and Evaluation
- PROCEDURE Phototherapy
- OTHER Internet-Based Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2026-12-23 |
| Est. Completion | 2027-07-05 |
| Phase | Phase 1 |
What is known before NCT07628894 opens enrollment
NCT07628894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07628894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07628894 about?
NCT07628894 is a clinical study titled "Circadian-Optimized Light Therapy for the Treatment of Patients With Advanced Melanoma Receiving Tumor-Infiltrating Lymphocyte Therapy". 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 ...
What is the current status of trial NCT07628894?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2026-12-23. Estimated completion is 2027-07-05.
What interventions are being tested in trial NCT07628894?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Medical Device Usage and Evaluation (OTHER), Phototherapy (PROCEDURE), Internet-Based Intervention (OTHER).
Who is sponsoring clinical trial NCT07628894?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07628894's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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