MelanomaPhase 2MelPORTNCT04594187
Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
A Phase 2 study testing Immunotherapy, Quality-of-Life Assessment and Radiation Therapy in people with Melanoma, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial summary
This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Immunotherapy, Quality-of-Life Assessment and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Aug 2020to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be planned for post-operative immunotherapy
- No evidence of distant metastasis as determined by clinical examination and any form of imaging
- No evidence of clinically involved lymph nodes prior to SLNB
- Pathologically confirmed sentinel lymph node positive melanoma with high risk features (extracapsular extension [ECE] or 0.5 mm+ nodal tumor implant or 2+ involved nodes or lymphovascular invasion of the primary tumor)
- Has provided written informed consent for participation in this trial
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
Show all 9Show fewer
- Life expectancy greater than 6 months
- Patients capable of childbearing are using adequate contraception
- Available for follow-up
Who cannot join
- Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN
- Distant metastasis
- Previous radiation therapy (RT) to the nodal area planned for RT such that the prior RT field would be included in the current treatment field. In other words, treatment on this trial would require re-irradiation of tissues
- Women who are pregnant
- Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Cooper Hospital UNIV MED CTR.
Camden, New Jersey, 08103
Gregory Kubicek, MD, 855-632-2667, Kubicek-Gregory@CooperHealth.edu
Gregory Kubicek, MD
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Devarati Mitra, 713-563-1339, dmitra@mdanderson.org
Devarati Mitra
- Recruiting
Baptist - MD Anderson Cancer Center
Jacksonville, Florida, 32207
Cynthia Anderson, MD, 904-202-7300, cynthia.anderson@bmcjax.com
About this study
Official title: The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine if regional nodal radiation therapy prolongs the time to regional recurrence.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive adjuvant immunotherapy and nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks).
GROUP II: Patients receive adjuvant immunotherapy alone.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
- Conditions
- Melanoma
- Being tested
- Immunotherapy, Quality-of-Life Assessment, Radiation Therapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyOther
Also called Immunological, Immunological Therapy, Immunologically Directed Therapy
All patients must be planned for treatment with any immunotherapy agent after sentinel lymph node biopsy (e.g. pembrolizumab or nivolumab). For patients receiving radiation therapy initiation may be before, during or after radiation.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation
Undergo nodal radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Group I (immunotherapy, radiation therapy) | Experimental | 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. Receives: Other: Immunotherapy; Other: Quality-of-Life Assessment; Radiation: Radiation Therapy |
| Group II (immunotherapy) | Active comparator | Patients planned to undergo immunotherapy. Receives: Other: Immunotherapy; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to regional nodal recurrence
Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up
Measured: From date of sentinel lymph node biopsy, assessed up to 5 years
Secondary outcomes (6)
Time to locoregional recurrence
Local recurrence, locoregional recurrence (including both regional recurrence and local recurrence at the primary tumor site) will also be assessed by physical exam and routine surveillance imaging during follow-up.
Measured: From date of sentinel lymph node biopsy, assessed up to 5 years
Time to distant metastasis
Distant metastasis will also be assessed by physical exam and routine surveillance imaging during follow-up.
Measured: From date of sentinel lymph node biopsy, assessed up to 5 years
Progression-free survival
Measured: From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years
Overall survival
Measured: From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years
Incidence of long term toxicity
Long term toxicity including lymphedema, infection, decreased mobility will be assessed at the time of routine follow up appointments. Physician-reported toxicity related to regional nodal disease or treatment will be recorded as per Common Terminology Criteria for Adverse Events version 5.0. Specific toxicity to be evaluated will include: fatigue, localized edema, lymphedema, pain, skin infection, soft tissue infection, thrush, radiation recall reaction, arthritis, fibrosis, joint range of motion, dysphagia, dysgeusia and dry skin.
Measured: Up to 5 years
Patient reported quality of life
Quality of life in all patients will be assessed by Functional Assessment of Cancer Therapy General survey. Patients with head and neck nodal disease will also be assessed by the University of Washington Quality of Life survey and patients with axillary nodal disease will also be assessed by the Lymphoedema Quality of Life-ARM.
Measured: At baseline, 3 months after sentinel lymph node biopsy, 9 months after sentinel lymph node biopsy, and 2 years after sentinel lymph node biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start7 Aug 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devarati Mitra, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594187
- Sponsor's protocol ID
- 2020-0148
- Other IDs
- NCI-2020-06904, 2020-0148
- Acronym
- MelPORT
- Status last verified
- Aug 2026
- First submitted
- 10 Oct 2020
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
- ClinicalTrials.gov ID
- NCT04594187
- Acronym / sponsor ID
- MelPORT / 2020-0148
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.
Detailed description
PRIMARY OBJECTIVE:
- To determine if regional nodal radiation therapy prolongs the time to regional recurrence.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive adjuvant immunotherapy and nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks).
GROUP II: Patients receive adjuvant immunotherapy alone.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (immunotherapy, radiation therapy) | Experimental | Other: Immunotherapy, Other: Quality-of-Life Assessment, Radiation: Radiation TherapyWithin 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 (immunotherapy) | Active comparator | Other: Immunotherapy, Other: Quality-of-Life AssessmentPatients planned to undergo immunotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be planned for post-operative immunotherapy
- No evidence of distant metastasis as determined by clinical examination and any form of imaging
- No evidence of clinically involved lymph nodes prior to SLNB
- Pathologically confirmed sentinel lymph node positive melanoma with high risk features (extracapsular extension [ECE] or 0.5 mm+ nodal tumor implant or 2+ involved nodes or lymphovascular invasion of the primary tumor)
- Has provided written informed consent for participation in this trial
Key exclusion criteria (5 listed)
- Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN
- Distant metastasis
- Previous radiation therapy (RT) to the nodal area planned for RT such that the prior RT field would be included in the current treatment field. In other words, treatment on this trial would require re-irradiation of tissues
- Women who are pregnant
- Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunotherapyAlso: Immunological, Immunological Therapy, Immunologically Directed TherapyAll patients must be planned for treatment with any immunotherapy agent after sentinel lymph node biopsy (e.g. pembrolizumab or nivolumab). For patients receiving radiation therapy initiation may be before, during or after radiation. | Other | Group I (immunotherapy, radiation therapy), Group II (immunotherapy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (immunotherapy, radiation therapy), Group II (immunotherapy) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, IrradiationUndergo nodal radiation therapy | Radiation | Group I (immunotherapy, radiation therapy) |
Primary outcome
Time to regional nodal recurrence
Time frame: From date of sentinel lymph node biopsy, assessed up to 5 years
Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up
6 secondary outcomes
Time to locoregional recurrence
Time frame: From date of sentinel lymph node biopsy, assessed up to 5 years
Time to distant metastasis
Time frame: From date of sentinel lymph node biopsy, assessed up to 5 years
Progression-free survival
Time frame: From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years
Overall survival
Time frame: From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years
Incidence of long term toxicity
Time frame: Up to 5 years
Patient reported quality of life
Time frame: At baseline, 3 months after sentinel lymph node biopsy, 9 months after sentinel lymph node biopsy, and 2 years after sentinel lymph node biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Devarati Mitra principal investigator
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immunotherapy, Quality-of-Life Assessment and Radiation Therapy in people with Melanoma, run by M.D. Anderson Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devarati Mitra (713-563-1339, dmitra@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to regional nodal recurrence (time frame: From date of sentinel lymph node biopsy, assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.