Morning light therapy alongside tumor-infiltrating lymphocyte treatment for advanced melanoma

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced melanoma whose disease progressed after immune checkpoint inhibitor therapy and who are going to have standard TIL therapy (lifileucel/Amtagvi). It tests morning light therapy at home alongside TIL therapy.

Age

18 years or older

Sex

All sexes can join

Disease stage

Advanced melanoma (stage III or stage IV cutaneous melanoma, including metastatic)

Earlier treatment

Disease progressed on or after immune checkpoint inhibitor therapy. Approved and consented for standard-of-care TIL therapy (lifileucel/Amtagvi).

Main reasons for not taking part

• Melatonin or sleep medicines (such as zolpidem, trazodone, benzodiazepines) within 14 days before enrolment
• Night shift work in the past 30 days or expected during the trial
• Travel across 2 or more time zones in the past 14 days
• Untreated moderate to severe obstructive sleep apnea
• History of mania, bipolar disorder, migraine or active seizure disorder

The registry criteria, word for word

What the trial wants to find out

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.

The group in the trial

• Treatment (COLT, TIL)Treatment being tested

  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.

  Treatment: Biospecimen Collection, Internet-Based Intervention, Medical Device Usage and Evaluation, Phototherapy, Questionnaire Administration, and Therapeutic Tumor Infiltrating Lymphocytes