Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Pembrolizumab | Biological | Pembrolizumab | ALIAS |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Therapeutic Exchange Plasma | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (radiation therapy, plasma exchange, immunotherapy)
- description
- Patients undergo radiation therapy daily on days 1-5 (weekdays). Patients then undergo therapeutic plasma exchange over 1-2 hours on the first session starting on the last day of radiation therapy and the last session ending prior to immunotherapy. Beginning day 5, patients receive pembrolizumab IV or nivolumab IV. Treatment with pembrolizumab continues every 3 weeks or treatment with nivolumab continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study and SOC CT, PET, and/or MRI scans as clinically indicated during follow-up.
- interventionNames
- Biological: Nivolumab
- Biological: Pembrolizumab
- Radiation: Radiation Therapy
- Biological: Therapeutic Exchange Plasma
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Procedure: Positron Emission Tomography
- Procedure: Magnetic Resonance Imaging
Primary outcomes (2)
- measure
- Feasibility of treatment approach
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) * 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
References
Publications (1)
- DERIVEDDavidson TM, Foster N, Lucien F, Markovic S, Dong H, Winters JL, Park SS, Orme JJ. Rescuing Cancer Immunity by Plasma Exchange in Metastatic Melanoma (ReCIPE-M1): protocol for a single-institution, open-label safety trial of plasma exchange to clear sPD-L1 for immunotherapy. BMJ Open. 2022 May 12;12(5):e050112. doi: 10.1136/bmjopen-2021-050112. PMID 35551087