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Checkpoint Inhibitor

Pembrolizumab + CMP-001 for Melanoma

Phase 2
Waitlist Available
Led By Ahmad Tarhini
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be >= 18 years of age
Patient must have a histologic diagnosis of melanoma belonging to specific American Joint Committee on Cancer (AJCC) 8th edition TNM stages
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

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.

Who is the study for?
Adults with operable melanoma, specifically nodal or in-transit cutaneous metastases, and no prior melanoma treatment can join. They must have good performance status (ECOG 0 or 1), injectable/measurable disease by scans, normal organ function tests, not be pregnant/breastfeeding, and willing to sign consent. Excluded are those with adrenal insufficiency, mucosal/uveal melanoma, brain metastases, severe heart/cardiac issues, immunodeficiency or on immunosuppressants.Check my eligibility
What is being tested?
The trial is testing if pembrolizumab alone or combined with CMP-001 improves outcomes for patients with surgically treatable melanoma. Pembrolizumab is an antibody that may help the immune system fight cancer; CMP-001 might boost this effect.See study design
What are the potential side effects?
Pembrolizumab can cause immune-related side effects like inflammation of organs (e.g., lungs causing pneumonitis), fatigue, infusion reactions and possibly affect liver enzymes. The combination with CMP-001 could potentially increase these risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My melanoma diagnosis matches specific cancer stage criteria.
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I am eligible for surgery to remove my cancer and have met with my cancer surgeon.
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I am fully active or can carry out light work.
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I have melanoma in my lymph nodes from an unknown source.
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I have not had systemic therapy for melanoma, including treatments like anti-PD-1.
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My cancer has spread to nearby lymph nodes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 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
Pathologic complete response rate
Secondary outcome measures
Incidence of adverse events
Overall survival
Radiographic response rate
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (CMP-001, pembrolizumab)Experimental Treatment7 Interventions
NEOADJUVANT PHASE: Patients receive CMP-001 SC on day 1 of cycle 1 and then intratumorally on days 8 and 15 of cycle 1, days 1, 8, and 15 of cycle 2, and day 1 of cycle 3. Patients also receive pembrolizumab IV over 30 minutes on day 8 of each cycle. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase. ADJUVANT PHASE: After recovery from surgery, patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET/CT throughout the trial and may undergo optional biopsy at baseline and disease progression and optional collection of blood samples throughout the trial.
Group II: Arm A (pembrolizumab)Experimental Treatment6 Interventions
NEOADJUVANT PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo surgery 1-2 weeks after completion of neoadjuvant phase. ADJUVANT PHASE: After recovery from surgery, patients receive pembrolizumab IV over 30 minutes on day 1 of every other cycle. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET/CT throughout the trial and may undergo optional biopsy at baseline and disease progression and optional collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Biopsy
2014
Completed Phase 4
~1090
Surgical Procedure
2016
Completed Phase 2
~150
Computed Tomography
2017
Completed Phase 2
~2720
Pembrolizumab
2017
Completed Phase 2
~2010
Positron Emission Tomography
2008
Completed Phase 2
~2240

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,212 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Ahmad TarhiniPrincipal InvestigatorECOG-ACRIN Cancer Research Group
4 Previous Clinical Trials
1,886 Total Patients Enrolled

Media Library

Cutaneous Melanoma Research Study Groups: Arm A (pembrolizumab), Arm B (CMP-001, pembrolizumab)
Cutaneous Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04708418 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04708418 — Phase 2

Frequently Asked Questions

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

What symptoms is Pembrolizumab used to alleviate?

"Pembrolizumab has the potential to treat malignant neoplasms, unresectable melanoma, microsatellite instability high cases, and can even be used as a form of chemotherapeutic progression."

Answered by AI

What is the upper limit for participants in this experiment?

"To move forward with the study, 54 patients that meet the requirements must be recruited. Those who wish to take part can visit two of many approved locations: University of Miami Miller School of Medicine-Sylvester Cancer Center in Miami, Florida and Southern Illinois University School of Medicine in Springfield, Illinois."

Answered by AI

To what extent could Pembrolizumab pose a hazard to individuals?

"Pembrolizumab scores a 2 on the safety scale as it is currently in phase two, meaning that while there is data affirming its security profile to some degree, there are no records of efficacy yet."

Answered by AI

What other tests have been conducted to evaluate the efficacy of Pembrolizumab?

"Pembrolizumab was initially studied at City of Hope in 2010, leading to 305 completed trials. As of today, there are 961 ongoing clinical studies with a significant presence being located in Miami, Florida."

Answered by AI

How many research laboratories have been enlisted to execute this experiment?

"The University of Miami Miller School of Medicine-Sylvester Cancer Center, Southern Illinois University School of Medicine, and Crossroads Cancer Centre are amongst the 80 medical centres that have been approved to recruit patients for this study."

Answered by AI

Is enrollment for this research still available to participants?

"Per information published on clinicaltrials.gov, this medical trial is actively seeking enrolment and was initially posted to the site on March 19th 2021 with the most recent update being December 3rd 2022."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Central Vermont Medical Center/National Life Cancer Treatment
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy in Patients With Operable Melanoma
2021. "A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy in Patients With Operable Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04708418.
~13 spots leftby Dec 2024
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