Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma
NCT ID: NCT04581382
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
18 participants
INTERVENTIONAL
2020-12-14
2024-10-06
Brief Summary
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Detailed Description
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I. To determine the kinetics of soluble (s)PD-L1 removal and regeneration by plasma exchange in patients with melanoma.
SECONDARY OBJECTIVES:
I. To observe response at 3 months after plasma exchange plus immunotherapy. II. To observe ongoing response at approximate 3 month intervals after plasma exchange plus immunotherapy.
CORRELATIVE RESEARCH OBJECTIVES:
I. To determine the effects of plasma exchange on immune cell function. II. To observe the kinetics of extracellular vesicles (EVs) after plasma exchange in patients with melanoma.
OUTLINE:
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 intravenously (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 standard of care (SOC) computed tomography (CT), positron emission tomography (PET), and/or magnetic resonance imaging (MRI) scans as clinically indicated during follow-up.
After completion of study treatment, patients are followed up at 3 weeks and then for up to 2 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (radiation therapy, plasma exchange, immunotherapy)
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.
Nivolumab
Given IV
Pembrolizumab
Given IV
Radiation Therapy
Undergo radiation therapy
Therapeutic Exchange Plasma
Undergo therapeutic plasma exchange
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Positron Emission Tomography
Undergo PET
Magnetic Resonance Imaging
Undergo MRI
Interventions
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Nivolumab
Given IV
Pembrolizumab
Given IV
Radiation Therapy
Undergo radiation therapy
Therapeutic Exchange Plasma
Undergo therapeutic plasma exchange
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Positron Emission Tomography
Undergo PET
Magnetic Resonance Imaging
Undergo MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Sean S. Park, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Jacob J. Orme, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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Davidson 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.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2020-06970
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC200703
Identifier Type: OTHER
Identifier Source: secondary_id
20-003367
Identifier Type: OTHER
Identifier Source: secondary_id
MC200703
Identifier Type: -
Identifier Source: org_study_id
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