NCT07660666Not yet recruiting
Feasibility of an Enhanced Symptom Monitoring and Expedited Subspecialty Care Referral Intervention to Improve Side Effect Management for Patients With Melanoma Receiving an Immune Checkpoint Inhibitor
EMPOWER: Enhancing Melanoma Care Through Patient-Reported Outcomes Monitoring With Early, Rapid Immunotherapy Toxicity Subspecialty Care
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
This clinical trial tests the feasibility of patient reported outcomes monitoring with early, rapid immunotherapy toxicity subspecialty care to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor. Immune checkpoint inhibitors have improved outcomes for patients with advanced melanoma, but their use is frequently complicated by immune related adverse events (irAEs). IrAEs can affect any organ system, range in severity from mild to life threatening, and often require a pause or stopping of immunotherapy treatment. Early identification and management of irAEs may reduce progression to severe toxicity. Electronic patient self reporting of symptoms with ways to support early involvement of non oncology subspecialists may be a feasible way to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Jun 2029
- Lead sponsor
- OHSU Knight Cancer Institute
- Diseases
- Melanoma
- NCT number
- NCT07660666
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Nov 2026 to the primary completion date, 1 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- PATIENT: Previously received ICI therapy
- PATIENT: Concurrently receiving a non-ICI systemic therapy
- PATIENT: Concurrently receiving radiation, unless hypofractionated palliative radiation prescribed to alleviate poorly controlled symptoms (e.g., pain)
Other
- PATIENT: Life expectancy of \< 6 months at time of enrollment
- PATIENT: Needs to rely on a proxy to complete patient-reported outcome instruments
- PATIENT: Unwilling or unable to complete surveys electronically
- CAREGIVER: Needs to rely on a proxy to complete survey instrument(s)
- CAREGIVER: Unwilling or unable to complete surveys electronically
Who the study is looking for
- PATIENT: Age 18 years or older
- PATIENT: Histologically confirmed diagnosis of melanoma
- PATIENT: Plan to begin a standard of care (SOC) immune checkpoint inhibitor (ICI) for the treatment of melanoma per Food and Drug Administration (FDA) approval and/or National Comprehensive Cancer Network (NCCN) guidelines
- PATIENT: Willing and able to provide informed consent
- CAREGIVER: Age 18 years or older
- CAREGIVER: Family member or primary caregiver of a study participant
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OHSU Knight Cancer Institute Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.