What side effects are associated with this type of intervention?

Common treatments for melanoma, such as immunotherapy and radiation therapy, have distinct side effect profiles. Immunotherapy, including immune checkpoint inhibitors like nivolumab and pembrolizumab, can cause immune-mediated adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Severe adverse events (grade ≥3) occur in about 30% of patients. Radiation therapy, particularly nodal radiation, can lead to side effects like skin irritation, fatigue, and lymphedema. These treatments aim to reduce the risk of recurrence by targeting and destroying cancer cells in the lymph nodes.

What prior FDA approvals exist?

The FDA has approved several treatments for melanoma that aim to reduce recurrence and target cancer cells in lymph nodes. Pembrolizumab, an immune checkpoint inhibitor, has been approved for high-risk stage III melanoma and has shown to prolong recurrence-free survival. Additionally, the combination of dabrafenib and trametinib, which targets BRAF V600 mutations, is approved for adjuvant therapy in patients with high-risk node-positive melanoma. These treatments, similar to nodal radiation therapy, aim to decrease the risk of nodal recurrence by targeting and destroying cancer cells in the lymph nodes.

What other types of research exist?

Promising alternatives to nodal radiation therapy for melanoma patients include: 1) Combination immunotherapy (e.g., nivolumab and ipilimumab), which has shown high pathologic response rates and improved survival outcomes. 2) Neoadjuvant immunotherapy, which can reduce the need for extensive surgery and improve quality of life. 3) Targeted therapies for BRAF V600-mutated tumors, such as combined BRAF/MEK inhibitors. These approaches offer effective treatment options with potential benefits in terms of response rates and reduced surgical morbidity.

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Immunotherapy

Radiation Therapy for Melanoma (MelPORT Trial)

Phase 2

Recruiting

Led By Devarati Mitra

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less

No evidence of distant metastasis as determined by clinical examination and any form of imaging

Must not have

Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study

Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing if adding radiation to lymph nodes along with immune-boosting medicine helps prevent cancer from coming back in patients with a specific type of skin cancer. It focuses on patients who have a high risk of their cancer spreading to their lymph nodes and are already planned to receive immunotherapy.

Who is the study for?

This trial is for adults with high-risk melanoma that's spread to sentinel lymph nodes but not elsewhere, who haven't had all their affected lymph nodes removed and are set for immunotherapy. They should be fairly active (ECOG ≤3), able to follow up, have a life expectancy over 6 months, and use contraception if capable of childbearing.

What is being tested?

The study is testing whether radiation therapy on the lymph nodes after a biopsy can lower the chance of cancer returning in those nodes for patients with high-risk melanoma starting immunotherapy, without removing more lymph nodes.

What are the potential side effects?

Potential side effects may include skin irritation or burns at the radiation site, fatigue from both radiation and immunotherapy treatments, as well as possible immune-related reactions due to immunotherapy.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but cannot do heavy physical work.

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My cancer has not spread to distant parts of my body.

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I am scheduled for immunotherapy after surgery.

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My melanoma has spread to my lymph nodes with high-risk features.

Exclusion Criteria

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

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I am an adult who can make my own medical decisions, not pregnant, and not incarcerated.

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I have had all lymph nodes removed where cancer was found.

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My cancer has spread to distant parts of my body.

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I am currently pregnant.

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I have had radiation therapy before in the same area that needs treatment now.

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

Time to regional nodal recurrence

Secondary study objectives

Incidence of long term toxicity

Patient reported quality of life

Time to distant metastasis

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (immunotherapy, radiation therapy)Experimental Treatment3 Interventions

Within 12 weeks of SLNB, patients start nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks). Immunotherapy planned to begin at any time after SLNB.

Group II: Group II (immunotherapy)Active Control2 Interventions

Patients planned to undergo immunotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 9Eligibility 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 include immunotherapy, targeted therapy, and radiation therapy. Immunotherapy, such as checkpoint inhibitors (e.g., nivolumab and ipilimumab), works by enhancing the body's immune response to recognize and destroy cancer cells. Targeted therapy involves drugs that specifically target genetic mutations in melanoma cells, such as BRAF inhibitors, which block the activity of the mutated BRAF protein that promotes cancer cell growth. Radiation therapy, including nodal radiation therapy, uses high-energy rays to target and destroy cancer cells in specific areas, such as the lymph nodes, reducing the risk of recurrence. These treatments are crucial for melanoma patients as they offer targeted approaches to control and eliminate cancer, potentially improving survival rates and quality of life.

Management of metastatic melanoma 2005.