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Checkpoint Inhibitor

Combination Therapy for Melanoma

Mayo Clinic in Rochester, Rochester, MN
Therapeutic Exchange Plasma +3 morePhase < 1Waitlist AvailableLed by Jacob J OrmeResearch Sponsored by Mayo Clinic

Study Summary

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

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have a medical condition that can or cannot be measured.

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

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 Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4120
Radiation Therapy
2017
Completed Phase 3
~7250
Pembrolizumab
2017
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,112 Previous Clinical Trials
3,502,882 Total Patients Enrolled
39 Trials studying Melanoma
2,515 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,486 Previous Clinical Trials
41,265,919 Total Patients Enrolled
556 Trials studying Melanoma
160,592 Patients Enrolled for Melanoma
Jacob J OrmePrincipal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
15 Total Patients Enrolled

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 carcinomae 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
~5 spots leftby Nov 2024