← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

MelPORT Trial Summary

This trial is testing whether nodal radiation therapy can decrease the risk of nodal recurrence in patients with high risk sentinel lymph node positive melanoma who are planned for 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.Check my eligibility

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.See study design

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.

MelPORT Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

Select...

I am scheduled for immunotherapy after surgery.

Select...

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

MelPORT Trial 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

Time to regional nodal recurrence

Secondary outcome measures

Incidence of long term toxicity

Overall survival

Patient reported quality of life

+3 more

Other outcome measures

Optional blood associated biomarkers of disease control and radiation-associated toxicity

Tissue associated biomarkers of disease control and radiation-associated toxicity

MelPORT 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,178 Total Patients Enrolled

102 Trials studying Melanoma

25,146 Patients Enrolled for Melanoma

Devarati MitraPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

52 Total Patients Enrolled

Media Library

Immunotherapy (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04594187 — Phase 2

Melanoma Research Study Groups: Group I (immunotherapy, radiation therapy), Group II (immunotherapy)

Melanoma Clinical Trial 2023: Immunotherapy Highlights & Side Effects. Trial Name: NCT04594187 — Phase 2

Immunotherapy (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04594187 — 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 participants can sign up for the experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which had its inception on August 26th 2021, is presently seeking to recruit subjects. The aim of the research is to secure 168 participants at two separate medical institutes."

Answered by AI

Has the FDA sanctioned radiation therapy as a viable medical treatment?

"There is evidence that radiation therapy may be safe, thus giving it a score of 2. However, there has yet to be any data establishing efficacy for the treatment in question."

Answered by AI

Are there any unfilled slots for participants in this medical experiment?

"Affirmative, the clinical trial is open for enrollment. It was initially posted on August 26th 2021 and its details were last amended on November 11th 2022. A total of 168 patients are needed from two distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma

2021. "Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04594187.

All > Melanoma