Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma
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|ClinicalTrials.gov Identifier: NCT04581382|
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : January 6, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: Nivolumab Biological: Pembrolizumab Radiation: Radiation Therapy Biological: Therapeutic Exchange Plasma||Early Phase 1|
I. To determine the kinetics of soluble (s)PD-L1 removal and regeneration by plasma exchange in patients with melanoma.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Radiation: Radiation Therapy
Undergo radiation therapy
Biological: Therapeutic Exchange Plasma
Undergo therapeutic plasma exchange
Other Name: TEP
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- Effects of plasma exchange on immune cell function [ Time Frame: Up to 2 years ]
- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referral Office 855-776-0015 firstname.lastname@example.org|
|Principal Investigator: Jacob J. Orme, M.D.|
|Principal Investigator:||Jacob J Orme||Mayo Clinic in Rochester|
|Responsible Party:||Mayo Clinic|
|Other Study ID Numbers:||
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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action