A Study to Evaluate Radiation Therapy, Plasma Exchange, and Immunotherapy in Melanoma

Overview

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:

  • Age ≥ 18 years.
  • 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.  Patient must meet one of these criteria.
  • ECOG Performance Status (PS) ≤ 3.
  • sPD-L1 levels >1.7 ng/ml.
  • 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.
  • Pregnant or nursing women.
  • Men or women of childbearing potential who are unwilling to employ adequate contraception.

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.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.

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