Study Summary
This trial is testing how well radiation therapy, plasma exchange, and either pembrolizumab or nivolumab work in treating patients with melanoma.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: Up to 2 years
Year 2
Overall survival (OS)
Year 2
Progression-free survival (PFS)
Up to 2 years
Effects of plasma exchange on immune cell function
Feasibility of treatment approach
Incidence of adverse events (AEs)
Kinetics of extracellular vesicles after plasma exchange in patients with melanoma
Kinetics of soluble (s)PD-L1 removal and regeneration by plasma exchange in patients with melanoma
Overall response rate
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Treatment (radiation therapy, plasma exchange, immunotherapy)
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Pembrolizumab · No Placebo Group · Phase < 1
Treatment (radiation therapy, plasma exchange, immunotherapy)Experimental Group · 4 Interventions: Pembrolizumab, Therapeutic Exchange Plasma, Nivolumab, Radiation Therapy · Intervention Types: Biological, Biological, Biological, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Nivolumab
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7010
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,072 Previous Clinical Trials
41,128,898 Total Patients Enrolled
543 Trials studying Melanoma
157,021 Patients Enrolled for Melanoma
Mayo ClinicLead Sponsor
2,918 Previous Clinical Trials
3,506,960 Total Patients Enrolled
36 Trials studying Melanoma
2,034 Patients Enrolled for Melanoma
Jacob J OrmePrincipal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
15 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are willing to return to the study institution for follow-up.
You are of childbearing potential.
You have a high level of sPD-L1 by ELISA.
The study apheresis technician determines that vascular access is feasible.
You provide written informed consent.
You are willing to provide blood samples for correlative research purposes.
References
- Davidson, Tara M, Nathan Foster, Fabrice Lucien, Svetomir Markovic, Haidong Dong, Jeffrey L Winters, Sean S Park, and Jacob J Orme. 2022. “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. BMJ. doi:10.1136/bmjopen-2021-050112.
- 2020. "Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04581382.
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Conditions
Cancer Related
Treatments