NCT04581382CompletedEarly phase 1
Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma
Radiation Therapy, Plasma Exchange, and Immunotherapy in Melanoma
Source: ClinicalTrials.gov · Last updated 10 Jul 2025
Brief summary (registry, in English)
This early phase I trial investigates how well radiation therapy, plasma exchange, and pembrolizumab or nivolumab work in treating patients with melanoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Plasma exchange (also known as "plasmapheresis") is a way to "clean" or "flush out" the blood. Immunotherapy with monoclonal antibodies, such as pembrolizumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Plasma exchange may help to improve the effect of standard radiation therapy and immunotherapy treatment on tumor cells of patients with melanoma.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 18 Sept 2020
- Start date
- 14 Dec 2020
- Primary completion date
- 6 Oct 2024
- Lead sponsor
- Mayo Clinic
- Diseases
- Melanoma
- NCT number
- NCT04581382
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 18
- From 14 Dec 2020 to the primary completion date, 6 Oct 2024
- 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.
Other
- Persons taking a biotin supplement
- sPD-L1 level \< 1.7 ng/ml by ELISA
- Pregnant or nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
Who the study is looking for
- Histological confirmation of melanoma. Patients may have completed biopsy outside of Mayo Clinic, but there must be an internal review done to confirm diagnosis prior to confirming eligibility
- Measurable or non-measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 3
- sPD-L1 levels \> 1.7 ng/ml by enzyme-linked immunosorbent assay (ELISA)
- Negative pregnancy test done =\< 7 days prior to radiation therapy, for women of childbearing potential only
- Provide written informed consent
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
- Willing to provide blood samples for correlative research purposes
Age in the registry: 18 years to - · Sex: All · Does not accept 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 |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.