Pembrolizumab for Cutaneous Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cutaneous Melanoma+7 More
Pembrolizumab - Biological
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

1 of 3

Other trials for Cutaneous Melanoma

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

2 of 3
This is further along than 68% of similar trials

Other trials for Cutaneous Melanoma

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 preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: October 17th, 2022

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 - 65100.0%
What site did they apply to?
Central Vermont Medical Center/National Life Cancer Treatment100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%