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Checkpoint Inhibitor

Combination Immunotherapy for Melanoma

Phase 1 & 2
Waitlist Available
Led By Matthew S. Block, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed diagnosis of unresectable stage III or metastatic melanoma (stage IV) not amenable to curative local therapy
Documented progression of disease after initiation of therapy with OR lack of response to therapy with a PD-1- or PD-L1-targeting monoclonal antibody (pembrolizumab, nivolumab, etc) after at least 18 weeks; NOTE: This treatment could have been at any time prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to the first 2 consecutive evaluations approximately 6 weeks apart assessed up to 5 years
Awards & highlights

Study Summary

This trial is testing a combination of therapies to treat melanoma- cryosurgery, dendritic cell therapy, and pembrolizumab.

Who is the study for?
This trial is for adults with advanced melanoma (stage III-IV) that can't be surgically removed. Participants must have measurable disease, adequate organ function, and no prior satisfactory response to PD-1 or PD-L1 inhibitors. They should not have active infections, certain heart conditions, other cancers needing treatment within 3 years, or severe autoimmune diseases. Pregnant individuals and those with HIV or hepatitis are excluded.Check my eligibility
What is being tested?
The study tests a combination of treatments: a vaccine made from the patient's own white blood cells mixed with tumor proteins (dendritic cell therapy), cryosurgery to freeze tumor cells, and pembrolizumab—an antibody targeting cancer growth. The goal is to see if this combo is more effective in treating melanoma than current methods.See study design
What are the potential side effects?
Potential side effects include typical reactions to vaccines such as soreness at injection site and flu-like symptoms; cryosurgery may cause local pain or skin damage; pembrolizumab can lead to immune-related issues like inflammation in organs, fatigue, skin rash, diarrhea, liver enzyme elevation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma cannot be removed by surgery and is at an advanced stage.
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My cancer progressed or didn't respond to specific immune therapy after 18 weeks.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have at least two treatable tumors not previously treated with radiation, excluding the brain.
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My kidney function, measured by creatinine levels, is within the normal range.
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My white blood cell count is healthy.
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I have at least one tumor that can be measured and hasn't been treated with radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to the first 2 consecutive evaluations approximately 6 weeks apart assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to the first 2 consecutive evaluations approximately 6 weeks apart assessed up to 5 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
Tumor response rate
Secondary outcome measures
Clinical benefit rate defined as the proportion of patients who have completed 6 courses of treatment without disease progression
Incidence of adverse events assessed using Common Terminology Criteria for Adverse Events (CTCAE)
Overall survival
+2 more
Other outcome measures
Change in PD-L1 levels
Change in the number of tumor infiltrating lymphocytes (TILs) in tumor biopsies

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (apheresis, pembrolizumab, cryosurgery, mDCs)Experimental Treatment4 Interventions
Patients undergo apheresis over 4 hours on day 1 or course 1. Patients also receive pembrolizumab IV over 30 minutes on day 1. Courses with pembrolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Within 36 hours after receiving pembrolizumab, patients undergo cryosurgery over 45 minutes on day 1 or 2 of courses 2 and 3. Patients also receive mature dendritic cells IT on day 1 or 2 of courses 2 and 3 after cryosurgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryosurgery
2015
Completed Phase 4
~540
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,044 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,639 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Matthew S. Block, M.D., Ph.D.Principal InvestigatorMayo Clinic
5 Previous Clinical Trials
192 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03325101 — Phase 1 & 2
Cutaneous Melanoma Research Study Groups: Treatment (apheresis, pembrolizumab, cryosurgery, mDCs)
Cutaneous Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03325101 — Phase 1 & 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03325101 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what reasons is Cryosurgery most commonly used?

"Cryosurgery can be used to treat cancerous growths, inoperable melanoma, and microsatellite instability."

Answered by AI

Are we currently enrolling patients in this trial?

"This specific study, whose first posting was on November 15th 2017, is not looking for new patients at this time according to clinicaltrials.gov. Although, there are 1848 other trials which ARE recruiting individuals right now."

Answered by AI

Does this treatment have a history?

"There are currently 1000 active clinical studies being conducted on cryosurgery, with 122 of those in the third and final phase. The majority of these trials originate from Houston, Texas; however, there are 36030 locations running similar studies."

Answered by AI

What is the upper limit for how many people can join this experiment?

"As of right now, this particular trial is not looking for any more participants. This information is based off the study's posting date (11/15/2017) as well as its last update (10/25/2022). For those still searching for trials to join, there are 848 clinical trials actively recruiting patients with stage iv cutaneous melanoma ajcc v6 and v7 and 1000 studies for Cryosurgery that need participants."

Answered by AI
~1 spots leftby Oct 2024