Pembrolizumab for Cutaneous Melanoma
Phase-Based Progress Estimates
Effectiveness
Safety
Cutaneous Melanoma+7 More
Pembrolizumab - BiologicalEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing pembrolizumab with or without CMP-001 to see if it can treat operable melanoma. Pembrolizumab is an immunotherapy that may help the body's immune system attack the cancer, and CMP-001 is an immunotherapy that may help the body's immune system attack the cancer and prevent the tumor cells from growing and spreading.
Eligible Conditions
- Cutaneous Melanoma
- Melanoma of Unknown Primary
- Recurrent Cutaneous Melanoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Up to 15 years
Year 15
Overall survival
Year 15
Relapse-free survival
Up to 15 years
Pathologic complete response rate
Radiographic response rate
Day 30
Incidence of adverse events
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Arm A (pembrolizumab)
1 of 2
Arm B (CMP-001, pembrolizumab)
1 of 2
Experimental Treatment
54 Total Participants · 2 Treatment Groups
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2
Arm A (pembrolizumab)Experimental Group · 4 Interventions: Computed Tomography, Positron Emission Tomography, Surgical Procedure, Pembrolizumab · Intervention Types: Procedure, Procedure, Procedure, Biological
Arm B (CMP-001, pembrolizumab)Experimental Group · 5 Interventions: Computed Tomography, Positron Emission Tomography, Surgical Procedure, Pembrolizumab, VLP-encapsulated TLR9 Agonist CMP-001 · Intervention Types: Procedure, Procedure, Procedure, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3410
Positron Emission Tomography
2008
Completed Phase 2
~2820
Surgical Procedure
2016
Completed Phase 2
~110
Pembrolizumab
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,298,834 Total Patients Enrolled
3 Trials studying Cutaneous Melanoma
118 Patients Enrolled for Cutaneous Melanoma
Ahmad TarhiniPrincipal InvestigatorECOG-ACRIN Cancer Research Group
4 Previous Clinical Trials
1,886 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:A melanoma that begins on the skin and spreads to other parts of the body, most often the lymph nodes.
A person has primary cutaneous melanoma, which is cancer that starts in the skin
Patients with in-transit cutaneous metastases that are considered potentially surgically resectable are allowed to participate in the study.
The patient must be at least 18 years old.
Patient must be able to take oral medication
Patient must have measurable disease
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and be able to take oral medication
after wide excision of the tumor suggests that regional nodal metastases are present
A melanoma that has returned after being treated and then reappears in the regional lymph nodes is likely to have spread to those nodes from the original tumor.
You have a clinically detected nodal melanoma (if single site) arising from an unknown primary.
Patients with mucosal and/or uveal melanoma are not eligible for the study.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Central Vermont Medical Center/National Life Cancer Treatment | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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