What side effects are associated with this type of intervention?

Common side effects of melanoma treatments similar to mRNA-4157 and pembrolizumab include fatigue, rash, pruritus, and diarrhea. Immune-related adverse events such as colitis, hepatitis, endocrinopathies, and pneumonitis are also frequent with pembrolizumab. Cancer vaccines like mRNA-4157 may cause injection site reactions, flu-like symptoms, and other immune-related effects. Combining these treatments could potentially amplify immune-related side effects.

What prior FDA approvals exist?

Pembrolizumab, an immune checkpoint inhibitor blocking the PD-1 pathway, has been approved by the FDA for the treatment of melanoma. Other similar FDA-approved treatments include nivolumab (another PD-1 inhibitor) and ipilimumab (a CTLA-4 inhibitor). These drugs enhance the immune response against melanoma cells. The combination of nivolumab and ipilimumab has also been approved and is effective in treating advanced or metastatic melanoma. These treatments are similar in their mechanism of action to the combination of mRNA-4157 and pembrolizumab being studied in the trial, as they both aim to stimulate the immune system to target tumor-specific antigens.

What other types of research exist?

Promising alternatives to mRNA-4157 and pembrolizumab for melanoma patients include: 1) Nivolumab, another PD-1 inhibitor, often used in combination with ipilimumab (a CTLA-4 inhibitor) for enhanced efficacy. 2) Talimogene laherparepvec (T-VEC) combined with pembrolizumab, which has shown positive results in advanced melanoma. 3) Relatlimab, a LAG-3 inhibitor, in combination with nivolumab, which targets different immune checkpoints to improve response rates. These alternatives offer different mechanisms of action and combination strategies that may benefit melanoma patients.

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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

Must not have

Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab

Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a combination of a personalized cancer vaccine (mRNA-4157) and an immune-boosting medication (pembrolizumab) can better prevent melanoma from returning in patients who have had their tumors surgically removed. Pembrolizumab has been shown to help prevent the return and spread of melanoma in patients who have had their tumors surgically removed.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken steroids or immunosuppressants in the last week.

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I have not had a blood transfusion or received colony-stimulating factors in the last 2 weeks.

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I have had interstitial lung disease before.

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I have been cancer-free from any previous cancer for at least 5 years.

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I am currently being treated for an infection.

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I have had a solid organ or bone marrow transplant.

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I have serious heart failure.

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I have had pneumonitis that needed steroids.

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I have been diagnosed with HIV.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Diagnostic Imaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3130

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for melanoma, such as mRNA-4157 and pembrolizumab, work by enhancing the body's immune response against cancer cells. mRNA-4157 is a personalized cancer vaccine that stimulates the immune system to recognize and attack tumor-specific antigens. Pembrolizumab is an immune checkpoint inhibitor that blocks the PD-1 pathway, which cancer cells use to evade immune detection. By blocking this pathway, pembrolizumab helps the immune system to better identify and destroy melanoma cells. These treatments are significant for melanoma patients as they offer targeted strategies to improve the immune system's ability to combat cancer, potentially leading to better recurrence-free survival and overall outcomes.

Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006).