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Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04581382
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : January 6, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Melanoma Biological: Nivolumab Biological: Pembrolizumab Radiation: Radiation Therapy Biological: Therapeutic Exchange Plasma Early Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

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 days 4-6 or 5-7. Beginning on day 7, 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.

After completion of study treatment, patients are followed up at 3 weeks and then for up to 2 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiation Therapy, Plasma Exchange, and Immunotherapy in Melanoma
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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 days 4-6 or 5-7. Beginning on day 7, 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.
 Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • CMAB819
  • MDX-1106
  • NIVO
  • Nivolumab Biosimilar CMAB819
  • ONO-4538
  • Opdivo

Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

Biological: Therapeutic Exchange Plasma
Undergo therapeutic plasma exchange
Other Name: TEP


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of treatment approach [ Time Frame: Up to 2 years ]
    Feasibility will be assessed by being able to complete the study accrual in a reasonable time period.

  2. Kinetics of soluble (s)PD-L1 removal and regeneration by plasma exchange in patients with melanoma [ Time Frame: Up to 2 years ]
    Graphical methods and descriptive statistics will be used to explore this endpoint. The Wilcoxon Signed-Rank test will be used to assess the change in the sPD-L1 levels over time across the different timepoints of interest.


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to 2 years ]
    Overall response rate is the proportion of patients with a tumor response (partial response or complete response at least 4 weeks apart).

  2. Progression-free survival (PFS) [ Time Frame: From registration to the first of either disease progression or death from any cause, assessed up to 2 years ]
    PFS will be estimated using the method of Kaplan-Meier.

  3. Overall survival (OS) [ Time Frame: From registration to death from any cause, assessed up to 2 years ]
    OS will be estimated using the method of Kaplan-Meier.

  4. Incidence of adverse events (AEs) [ Time Frame: Up to 2 years ]
    The descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 will be utilized for AE reporting. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns.


Other Outcome Measures:
  1. Effects of plasma exchange on immune cell function [ Time Frame: Up to 2 years ]
  2. Kinetics of extracellular vesicles after plasma exchange in patients with melanoma [ Time Frame: Up to 2 years ]
    Will associate the kinetics with clinical outcome data (response rate, OS, PFS).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  • Feasible vascular access as determined by study apheresis technician (either by peripheral intravenous access or by placement of a temporary central line)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581382


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Jacob J. Orme, M.D.         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jacob J Orme Mayo Clinic in Rochester
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04581382    
Other Study ID Numbers: MC200703
NCI-2020-06970 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC200703 ( Other Identifier: Mayo Clinic in Rochester )
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Pembrolizumab
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action