A Study to Evaluate Radiation Therapy, Plasma Exchange, and Immunotherapy in Melanoma
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-003367
NCT ID: NCT04581382
Sponsor Protocol Number: MC200703
About this study
The purpose of this study is to determine the kinetics of sPD-L1 removal and regeneration by plasma exchange in patients with melanoma.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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)
- Feasible vascular access as determined by study apheresis technician (either by
peripheral intravenous access or by placement of a temporary central line)
- 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
Exclusion Criteria:
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 2/28/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Sean Park, M.D., Ph.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available