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Checkpoint Inhibitor

mRNA Vaccine + Immunotherapy for Melanoma

Phase 2

Recruiting

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Complete resection within 13 weeks prior to the first dose of pembrolizumab

Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will test whether adding the immunotherapy drug, mRNA-4157, to standard of care, pembrolizumab, will improve recurrence free survival in people with high risk melanoma who have had surgery to remove the tumor.

Who is the study for?

This trial is for individuals who've had surgery to remove melanoma that spread to a lymph node and are at high risk of the cancer coming back. They should have no current evidence of disease, be in good physical condition (able to perform daily activities or light work), and have normal organ/marrow function. People with prior cancers, recent vaccines, blood transfusions, infections needing treatment, HIV/hepatitis B/C, autoimmune diseases or immunosuppression can't join.Check my eligibility

What is being tested?

The study is testing if adding a personalized cancer vaccine called mRNA-4157 to pembrolizumab (a known immune therapy) after surgery can prevent melanoma from returning better than pembrolizumab alone. Participants will either receive the combination treatment or just pembrolizumab.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in various organs including lungs (pneumonitis), flu-like symptoms from the vaccine, fatigue, skin reactions at injection sites and potential activation of autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery to remove my cancer completely within the last 13 weeks.

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My skin cancer has spread to a lymph node and is likely to come back.

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I am fully active or can carry out light work.

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I am currently free of cancer after surgery, with no signs of it returning or spreading.

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My organ and bone marrow functions are normal.

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I have a preserved tumor sample available for genetic testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging

Secondary outcome measures

Diagnostic Imaging

Number of Participants Who Discontinued Due to AEs

Number of Participants With Adverse Events (AEs)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: mRNA-4157 and PembrolizumabExperimental Treatment2 Interventions

Participants will receive up to 9 doses of mRNA-4157 (every 21 days). Participants may continue on pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.

Group II: PembrolizumabActive Control1 Intervention

Participants will receive pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor

108 Previous Clinical Trials

61,379,060 Total Patients Enrolled

1 Trials studying Melanoma

1,089 Patients Enrolled for Melanoma

Merck Sharp & Dohme LLCIndustry Sponsor

3,890 Previous Clinical Trials

5,060,044 Total Patients Enrolled

120 Trials studying Melanoma

21,426 Patients Enrolled for Melanoma

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03897881 — Phase 2

Melanoma Research Study Groups: mRNA-4157 and Pembrolizumab, Pembrolizumab

Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03897881 — Phase 2

Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03897881 — Phase 2

Frequently Asked Questions

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

How many people are being tested in this experiment?

"Unfortunately, this particular trial is not currently seeking patients. The listing was created on July 18th, 2019 but was last updated on August 23rd, 2022. However, there are presently 784 other clinical trials actively recruiting patients with melanoma and 1000 mRNA-4157 trials also looking for participants."

Answered by AI

For what reason is the mRNA-4157 medication most often prescribed?

"mRNA-4157 is commonly used to treat malignant neoplasms, but it can also help patients microsatellite instability high and those that have disease progression after chemotherapy."

Answered by AI

At how many different hospitals is this clinical trial taking place?

"Across the United States, there are 17 hospitals recruiting patients for this study. Some of these locations include Massachusetts General Hospital in Boston, Smilow Cancer Center at Yale New Haven Hospital in New Haven, and University of Colorado Cancer Center in Aurora."

Answered by AI

Could you tell me if mRNA-4157 has been explored in other research?

"Currently, there are 1000 active clinical trials studying mRNA-4157. Out of these, 122 are in Phase 3. Additionally, while many of the clinical trials for mRNA-4157 are based in Houston, Texas, there are 36034 locations running studies for this medication across the globe."

Answered by AI

What is the governmental organization's stance on mRNA-4157?

"While Phase 2 trials don't have the same level of data supporting efficacy, mRNA-4157's safety was rated a 2 because there is some clinical evidence to suggest it's safe."

Answered by AI

Are patients currently being recruited for this clinical trial?

"The clinical trial, which was first posted on July 18th 2019, is no longer recruiting patients. This information can be found on clinicaltrials.gov and the most recent edit was made on August 23rd, 2022. Although this specific study has completed recruitment, there are 1,784 other trials currently looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)

2019. "An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03897881.

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