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Checkpoint Inhibitor

Combination Therapy for Melanoma

Phase < 1
Waitlist Available
Led By Sean S. Park, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 3
Feasible vascular access as determined by study apheresis technician (either by peripheral intravenous access or by placement of a temporary central line)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing how well radiation therapy, plasma exchange, and either pembrolizumab or nivolumab work in treating patients with melanoma.

Who is the study for?
This trial is for melanoma patients with measurable or non-measurable disease, able to visit the study site for follow-up, and have proper vascular access. Participants must not be pregnant, agree to use contraception if of childbearing potential, provide consent and blood samples for research, have a performance status score of 3 or less (meaning they are capable of self-care), and an sPD-L1 level above 1.7 ng/ml.Check my eligibility
What is being tested?
The trial investigates the combination of radiation therapy (high energy x-rays to kill tumor cells), plasma exchange ('flushing out' the blood), and immunotherapy drugs pembrolizumab or nivolumab in treating melanoma. It aims to see how well these treatments work together in attacking cancer cells and limiting their growth.See study design
What are the potential side effects?
Potential side effects include typical reactions from radiation like skin changes and fatigue; plasma exchange may cause dizziness or allergic reactions; immunotherapies can lead to immune system-related inflammation affecting various organs, infusion reactions, tiredness, digestive issues, skin rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but can't do heavy physical work.
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A technician can easily access my veins for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of treatment approach
Kinetics of soluble (s)PD-L1 removal and regeneration by plasma exchange in patients with melanoma
Secondary outcome measures
Incidence of adverse events (AEs)
Overall response rate
Overall survival (OS)
+1 more
Other outcome measures
Effects of plasma exchange on immune cell function
Kinetics of extracellular vesicles after plasma exchange in patients with melanoma

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (radiation therapy, plasma exchange, immunotherapy)Experimental Treatment8 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Positron Emission Tomography
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Nivolumab
2014
Completed Phase 3
~4750
Radiation Therapy
2017
Completed Phase 3
~7250
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,227 Previous Clinical Trials
3,771,650 Total Patients Enrolled
40 Trials studying Melanoma
2,505 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,353 Total Patients Enrolled
557 Trials studying Melanoma
193,172 Patients Enrolled for Melanoma
Sean S. Park, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04581382 — Phase < 1
Melanoma Research Study Groups: Treatment (radiation therapy, plasma exchange, immunotherapy)
Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04581382 — Phase < 1
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04581382 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab been examined in any other research projects?

"Currently, 1633 studies are in progress studying Pembrolizumab with 200 of them being Phase 3 trials. Houston, Texas is a major centre for these clinical investigations but there are over 73,000 sites conducting experiments concerning this medication worldwide."

Answered by AI

What goals is this research attempting to achieve?

"The principal outcome that will be monitored for up to 24 months is the feasibility of this treatment regimen. Secondary objectives include assessing progression-free survival, overall response rate and overall survival via Kaplan-Meier estimates."

Answered by AI

What is the cap on the number of participants in this medical experiment?

"Yes, the information on clinicaltrials.gov affirms that this scientific exploration is currently accepting applicants. It was initially advertised in December of 2020 and most recently updated in May 2022. The experiment is accommodating 20 subjects across a single site."

Answered by AI

What indications is Pembrolizumab routinely prescribed for?

"Pembrolizumab is a viable treatment for unresectable melanoma, as well as microsatellite instability high and squamous cell carcinoma cases with a heightened risk of recurrence."

Answered by AI

Does this clinical experiment currently admit participants?

"Per the data posted on clinicaltrials.gov, this study is actively enrolling participants and has been since December 14th 2020 (latest update - 5 May 2022)."

Answered by AI
Recent research and studies
BMJ OpenJournal
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
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.
clinicaltrials.govStudy
Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma
2020. "Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04581382.
All > Melanoma
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