MelanomaEXCILYNTNCT05839912
Excision of Lymph Node Trial (EXCILYNT) (Mel69)
A study testing Excision of clinically detected lymph node metastasis before any systemic therapy and Excision of clinically detected lymph node metastasis after neoadjuvant systemic therapy in people with Melanoma, run by Craig L Slingluff, Jr at 7 sites in United States.
Trial summary
The purpose of this study is to find out if removing only the cancerous lymph node (known as a lymph node excision) is effective at preventing cancer from coming back in the same area of the lymph node excision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Excision of clinically detected lymph node metastasis before any systemic therapy and Excision of clinically detected lymph node metastasis after neoadjuvant systemic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Sep 2023to 1 Sep 2028
- Phase
- Interventional
- 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
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 years or older at enrollment
- ECOG performance status of 0-2
- Subjects must have histologically (or cytologically) confirmed metastatic melanoma to only one lymph node in the axilla, groin, or iliac basin that was detected clinically. A clinically positive lymph node is defined as a palpable and clinically suspicious node (based on palpation or imaging), or non-palpable lymph node that is FDG-avid or ≥ 0.95 cm on PET-CT, based on professional assessment of the radiologist, and that also is confirmed to contain metastatic melanoma on biopsy.
- The clinically positive lymph node may have been removed within 8 weeks prior to enrollment, and in that case may or may not have been evaluated by PET-CT; it is considered a clinically positive node if it was either identified as clinically suspicious on exam and/or on preoperative scans based on FDG-avidity and/or diameter ≥ 0.95 cm, and also confirmed histologically. The clinically positive node must be within the primary draining node basin of the primary melanoma, or the metastasis may be from an unknown primary site. A node that was removed at sentinel node biopsy will not meet this eligibility criterion. A patient will not be eligible if there is evidence of an additional clinically positive node on imaging or physical exam after excision of the first clinically positive node.
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- Subjects must be able to undergo LNEx and must not be on a clinical trial that requires TLND.
- Subjects may have previously had metastatic melanoma to a sentinel node in the same node basin, if complete lymph node dissection was not done, and if at least 1 year has elapsed since the prior positive sentinel node biopsy.
- Individuals will be required to have radiological studies to rule out radiologically evident melanoma metastasis. Required studies include:
- PET-CT scan, and
- Head CT scan or MRI These scans may have been performed prior to resection of the primary melanoma and/or sentinel node biopsy if they showed no evidence of other metastases.
Who cannot join
- Subjects who have had a prior complete lymph node dissection or radiation therapy of the clinically positive node basin.
- Subjects who have, or have had, in-transit or satellite metastases from the same primary melanoma that has metastasized to the cLN that is the focus of the current study.
- The only exception are subjects who have had in-transit or satellite metastases without intervening recurrence within the year prior to the subject's enrollment on the study.
- Subjects who have, or have had, one or more metastases distant to the primary draining lymph node basin. An individual with small radiologic or clinical findings of an indeterminate nature may still be eligible: examples include a new 5 mm lung nodule that is too small to characterize or an asymptomatic 12 mm bony lucency that is not classic for malignancy, where clinical care may otherwise be to follow the patient with repeat imaging rather than to treat the lesion.
- Subjects with pre-existing lymphedema that precludes assessment of lymphedema. Pre-existing lymphedema should be discussed with the principal investigator (PI) at the treating institution or the overall study PI. Some patients with mild stable lymphedema at the time of enrollment may still be evaluable. The primary endpoint for lymphedema measurement is the circumference 10 cm proximal to ankle/wrist on the involved side vs the contralateral side. If there is a pre-existing difference, then it will be important to be able to assess for meaningful increases after surgery.
- Subjects whose treating physician(s) plan adjuvant radiation therapy to the involved node basin, because that also would confound assessment of node basin recurrence and lymphedema.
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- Individuals for whom there is a medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator.
- Subjects with a prior or concurrent malignancy may be eligible if its natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the regimen.
- Subjects who are receiving systemic or intratumoral therapy for this melanoma within 3 months of enrollment. They may have received prior adjuvant systemic therapy for an earlier stage of disease, but should be off that therapy for 3 months prior to enrollment.
- The only exception is for patients who are being treated at a participating center with neoadjuvant therapy for 1 cLN, and who otherwise meet criteria for enrollment. They should be screened and enrolled as soon as possible. The intent of this exception is to allow enrollment of patients who are being evaluated at that center before the study is open but whose LN Excision date can occur after the study is open to enrollment, or for patients who are not able to make a decision about enrollment on this study prior to starting neoadjuvant therapy. For such patients, data collected prior to starting neoadjuvant therapy should be recorded as screening data (such as imaging studies), but baseline lymphedema measurements, FACT-M and WPAI surveys, and anything else not done prior to starting neoadjuvant therapy should be performed as soon as possible, and prior to LN Excision. This exception does reduce the power to address some exploratory endpoints; so, use of this exception should be minimized as much as possible.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
Emory University
Atlanta, Georgia, 30322
Bridney Stewart, 404-778-4520, bridney.giovonni.stewart@emory.edu
- Not yet recruiting
University of Maryland
Baltimore, Maryland, 21201
- Recruiting
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
Chandler Warren, chandler.warren@duke.edu
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Lymph Node Excision (LNEx) for Patients With Stage III Melanoma With One Clinically Positive Node: Excision of Lymph Node Trial [EXCILYNT]
The purpose of this study is to find out if removing only the cancerous lymph node (known as a lymph node excision) is effective at preventing cancer from coming back in the same area of the lymph node excision. The study team is also trying to find out the side effects of this type of surgery and how much the surgery impacts quality of life.
In order to be eligible for this study, participants must have been diagnosed with metastatic melanoma and have one detected cancerous lymph node by imaging (CT/PET scan) or clinical examination, and are a candidate for lymph node excision.
- Conditions
- Melanoma
- Being tested
- Excision of clinically detected lymph node metastasis before any systemic therapy, Excision of clinically detected lymph node metastasis after neoadjuvant systemic therapy
- Keywords
- melanoma, surgery, lymph node excision
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision of clinically detected lymph node metastasis before any systemic therapyProcedure or surgery
Surgical intervention to remove the clinically detected lymph node metastasis after which physician choice adjuvant systemic therapy is permitted
Excision of clinically detected lymph node metastasis after neoadjuvant systemic therapyProcedure or surgery
Surgical intervention to remove the clinically detected lymph node metastasis after physician choice neo adjuvant systemic therapy. Physician choice adjuvant therapy is allowed after surgery
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Excision of cLN before systemic therapy | Experimental | Excision of the clinically detected metastatic lymph node before systemic therapy. Receives: Procedure: Excision of clinically detected lymph node metastasis before any systemic therapy |
| Cohort 2: Excision of cLN after neoadjuvant systemic therapy | Experimental | Excision of the clinically detected metastatic lymph node after systemic neoadjuvant therapy. Receives: Procedure: Excision of clinically detected lymph node metastasis after neoadjuvant systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Node basin-only recurrence
Number of participants with recurrence of melanoma within the node basin without concurrent or preceding distant metastatic recurrence
Measured: 3 years after the lymph node excision
Secondary outcomes (1)
Lymphedema
Proportion of patients with lymphedema in the extremity closest to the dissected lymph node basin
Measured: within 3 years after the lymph node excision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start6 Sep 2023
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig L Slingluff, Jr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Craig L Slingluff, Jr., MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839912
- Sponsor's protocol ID
- 230011
- Acronym
- EXCILYNT
- Status last verified
- Sep 2025
- First submitted
- 20 Apr 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymph Node Excision (LNEx) for Patients With Stage III Melanoma With One Clinically Positive Node: Excision of Lymph Node Trial [EXCILYNT]
- ClinicalTrials.gov ID
- NCT05839912
- Acronym / sponsor ID
- EXCILYNT / 230011
- Conditions
- Melanoma
- Keywords
- melanoma, surgery, lymph node excision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Craig L Slingluff, JrUniversity, hospital or other
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 3 May 2023 (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.
The purpose of this study is to find out if removing only the cancerous lymph node (known as a lymph node excision) is effective at preventing cancer from coming back in the same area of the lymph node excision. The study team is also trying to find out the side effects of this type of surgery and how much the surgery impacts quality of life.
In order to be eligible for this study, participants must have been diagnosed with metastatic melanoma and have one detected cancerous lymph node by imaging (CT/PET scan) or clinical examination, and are a candidate for lymph node excision.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Excision of cLN before systemic therapy | Experimental | Procedure: Excision of clinically detected lymph node metastasis before any systemic therapyExcision of the clinically detected metastatic lymph node before systemic therapy. |
| Cohort 2: Excision of cLN after neoadjuvant systemic therapy | Experimental | Procedure: Excision of clinically detected lymph node metastasis after neoadjuvant systemic therapyExcision of the clinically detected metastatic lymph node after systemic neoadjuvant therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 18 years or older at enrollment
- ECOG performance status of 0-2
- Subjects must have histologically (or cytologically) confirmed metastatic melanoma to only one lymph node in the axilla, groin, or iliac basin that was detected clinically. A clinically positive lymph node is defined as a palpable and clinically suspicious node (based on palpation or imaging), or non-palpable lymph node that is FDG-avid or ≥ 0.95 cm on PET-CT, based on professional assessment of the radiologist, and that also is confirmed to contain metastatic melanoma on biopsy.
Key exclusion criteria (10 listed)
- Subjects who have had a prior complete lymph node dissection or radiation therapy of the clinically positive node basin.
- Subjects who have, or have had, in-transit or satellite metastases from the same primary melanoma that has metastasized to the cLN that is the focus of the current study.
- Subjects who have, or have had, one or more metastases distant to the primary draining lymph node basin. An individual with small radiologic or clinical findings of an indeterminate nature may still be eligible: examples include a new 5 mm lung nodule that is too small to characterize or an asymptomatic 12 mm bony lucency that is not classic for malignancy, where clinical care may otherwise be to follow the patient with repeat imaging rather than to treat the lesion.
- Subjects with pre-existing lymphedema that precludes assessment of lymphedema. Pre-existing lymphedema should be discussed with the principal investigator (PI) at the treating institution or the overall study PI. Some patients with mild stable lymphedema at the time of enrollment may still be evaluable. The primary endpoint for lymphedema measurement is the circumference 10 cm proximal to ankle/wrist on the involved side vs the contralateral side. If there is a pre-existing difference, then it will be important to be able to assess for meaningful increases after surgery.
- Subjects whose treating physician(s) plan adjuvant radiation therapy to the involved node basin, because that also would confound assessment of node basin recurrence and lymphedema.
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 |
|---|---|---|
| Excision of clinically detected lymph node metastasis before any systemic therapySurgical intervention to remove the clinically detected lymph node metastasis after which physician choice adjuvant systemic therapy is permitted | Procedure or surgery | Cohort 1: Excision of cLN before systemic therapy |
| Excision of clinically detected lymph node metastasis after neoadjuvant systemic therapySurgical intervention to remove the clinically detected lymph node metastasis after physician choice neo adjuvant systemic therapy. Physician choice adjuvant therapy is allowed after surgery | Procedure or surgery | Cohort 2: Excision of cLN after neoadjuvant systemic therapy |
Primary outcome
Node basin-only recurrence
Time frame: 3 years after the lymph node excision
Number of participants with recurrence of melanoma within the node basin without concurrent or preceding distant metastatic recurrence
1 secondary outcome
Lymphedema
Time frame: within 3 years after the lymph node excision
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 17 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Craig L Slingluff, Jr., MD principal investigator
University of Virginia
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excision of clinically detected lymph node metastasis before any systemic therapy and Excision of clinically detected lymph node metastasis after neoadjuvant systemic therapy in people with Melanoma, run by Craig L Slingluff, Jr at 7 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 11 inclusion and 10 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 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
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 Samantha Schaeffer (434-982-6714, SMS6WN@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Node basin-only recurrence (time frame: 3 years after the lymph node excision). 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 17 Sep 2025.