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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can take care of myself but can't do heavy physical work.
Select...
A technician can easily access my veins for treatment.
Select...
My cancer can be measured by tests or seen on scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreOther outcome measures
Effects of plasma exchange on immune cell function
Kinetics of extracellular vesicles after plasma exchange in patients with melanoma
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
~4750
Radiation Therapy
2017
Completed Phase 3
~7250
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,065 Total Patients Enrolled
40 Trials studying Melanoma
2,505 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,649 Total Patients Enrolled
557 Trials studying Melanoma
193,215 Patients Enrolled for Melanoma
Jacob J OrmePrincipal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but can't do heavy physical work.A technician can easily access my veins for treatment.You have been diagnosed with melanoma, and the diagnosis needs to be confirmed by the Mayo Clinic before participating in the trial.My cancer can be measured by tests or seen on scans.I am currently taking biotin supplements.Your sPD-L1 level is less than 1.7 ng/ml as tested by ELISA.I am not willing to use birth control.Your sPD-L1 levels measured by a specific test are higher than 1.7 ng/ml.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (radiation therapy, plasma exchange, immunotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 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
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