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Checkpoint Inhibitor

Combination Therapy for Melanoma

Phase < 1

Waitlist Available

Led By Jacob J Orme

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)

Must not have

Persons taking a biotin supplement

Men or women of childbearing potential who are unwilling to employ adequate contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking biotin supplements.

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I am not willing to use birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of treatment approach

Kinetics of soluble (s)PD-L1 removal and regeneration by plasma exchange in patients with melanoma

Secondary study objectives

Incidence of adverse events (AEs)

Overall response rate

Overall survival (OS)

+1 more

Other study objectives

Kinetics of extracellular vesicles after plasma exchange in patients with melanoma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Radiation Therapy

2017

Completed Phase 3

~7250

Nivolumab

2014

Completed Phase 3

~5220