Melanoma, SkinOMITNCT06754904
Omitting Therapeutic Lymph Node Dissection in Patients With Melanoma (Stage 3) and Major Pathological Response in the Index Lymph Node
A study testing Omitting TLND and Index node procedure in people with Melanoma, Skin, run by D.J. (Dirk) Grünhagen at 1 site in Netherlands.
Trial summary
Rationale: The randomized trial NADINA has demonstrated that neoadjuvant treatment with nivolumab with ipilimumab improves event-free survival (EFS) in patients with macroscopic resectable stage III melanoma. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Melanoma, Skin
- What is being tested?
- Omitting TLND and Index node procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Apr 2025to 1 Apr 2032
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be eligible for neoadjuvant treatment (ipilimumab and nivolumab)
- Patients must be 16 years of age or older.
- Patients must have a histologically confirmed diagnosis of macroscopic resectable stage III melanoma (stage III B/C/D) with one or more macroscopic lymph node metastase defined as either one:
- a palpable node, confirmed as melanoma by pathology; a non-palpable but enlarged lymph node according to RECISTv1.1 (at least 15 mm in short axis), confirmed as melanoma by pathology;
- a PET scan positive lymph node of any size confirmed as melanoma by pathology;
- The patient must have a measurable tumor burden that qualifies (according to clinical practice) for neoadjuvant therapy with immune checkpoint inhibitors
- Patients in whom ILN marking is feasible
- Written informed consent
Who cannot join
- Uveal/ocular or mucosal melanoma
- WHO performance status of two or more
- In-transit metastases only (without cytological or histological proven lymph node involvement)
- Prior targeted therapy targeting BRAF and/or MEK for melanoma
- Prior immunotherapy targeting CTLA-4, PD-1 or PD-L1 for melanoma
- Patients with (history of) distant metastasis (stage IV melanoma)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015GD
Prof. D.J. Grünhagen, +31 10 704 19 02, d.grunhagen@erasmusmc.nl
About this study
Official title: OMIT Trial: Omitting Therapeutic Lymph Node Dissection in Patients With Stage IIIB/C Melanoma and Major Pathological Response in the Index Lymph Node After Neoadjudvant Immunotherapy
Rationale: The randomized trial NADINA has demonstrated that neoadjuvant treatment with nivolumab with ipilimumab improves event-free survival (EFS) in patients with macroscopic resectable stage III melanoma. In this study, therapeutic lymph node dissection (TLND) was standard of care, showing that patients achieving a major pathological response (MPR, i.e., ≤10% residual viable tumor bed) have an excellent outcome (EFS and Distant Metastasis Free Survival (DMFS)). The PRADO trial indicated that the MPR definition can also be revealed from a surrogate lymph node response, the index lymph node (ILN), allowing sparing the extensive surgery in MPR patients. In these MPR patients the DMFS was 100% after 1 year and 98% after 2 years, and recurrence-free survival (RFS) was 95% after 1 year and 93% after 2 years. Given that TLND is associated with morbidity and has a significant impact on health-related quality of life (HR-QoL) and healthcare costs, this study aims to prospectively investigate the safety of omitting TLND in patients who have an MPR within the ILN after neoadjuvant immunotherapy.
Objectives: To investigate whether TLND can be safely omitted in patients with macroscopic resectable stage III (B/C/D) melanoma achieving an MPR within the ILN upon neoadjuvant treatment with immune checkpoint inhibitors (ipilimumab and nivolumab).
Read more
Study design: This study is a prospective, single-arm phase 2 nationwide multicenter trial.
Study population:
Inclusion criteria for study participants are as follows:
- Patients must be eligible for neoadjuvant treatment
- Patients must have a histologically confirmed diagnosis of macroscopic resectable stage III melanoma (stage III B/C/D) with one or more macroscopic lymph node metastasis
- The patient must have a measurable tumor burden that qualifies (according to clinical practice) for neoadjuvant therapy
Intervention: Omitting TLND in patients who achieve an MPR in the ILN following neoadjuvant ipilimumab and nivolumab.
Main study endpoints: The two coprimary endpoints are 2-year Local Recurrence Free Survival (LRFS) and 2-year DMFS.
- Conditions
- Melanoma, Skin
- Being tested
- Omitting TLND, Index node procedure
- Keywords
- Neoadjuvant, Ipilimumab, Nivolumab, Immunotherapy, Index node, Therapeutic lymph node dissection, Omitting
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omitting TLNDProcedure or surgery
Omitting TLND in patients who achieve an MPR in the index node following neoadjuvant ipilimumab and nivolumab.
Index node procedureProcedure or surgery
Index node procedure
| Study group | Role | What they receive |
|---|---|---|
| Omitting TLND | Experimental | Omitting TLND in patients who achieve an MPR in the ILN following neoadjuvant ipilimumab and nivolumab. Receives: Procedure: Omitting TLND; Procedure: Index node procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Recurrence Free Survival (LRFS)
LRFS, as defined as time from removal of the index lymph node (ILN) until local (in basin) recurrence in the MPR group. Accepting a local relapse of 20%.
Measured: 2 years after inclusion
Distant Metastasis Free Survival (DMFS)
DMFS assessed in the MPR group, as defined as time from the start of neoadjuvant immunotherapy, nivolumab with ipilimumab, until the first occurrence of distant metastasis. Accepting DMFS 3% lower than the 2 years DMFS of the NADINA trial
Measured: 2 years after inclusion
Secondary outcomes (9)
Evaluation of health-related quality of life (HRQoL), EORTC QLQ C30
Description of the changes in HR-QoL scores from baseline to follow-up visits, measured by validated questionnaires using EORTC Quality of Life Questionnaire-core 30 (EORTC QLQ C30). The EORTC QLQ C30 is scored on 4 point Likert-scales: "Not at all", "A little", "Quite a bit", and "Very much."
Measured: 3 years after inclusion
Evaluation of health-related quality of life (HRQoL), FACT-M
Description of the changes in HR-QoL scores from baseline to follow-up visits, measured by validated questionnaires using Melanoma Surgery Specific subscale of the FACT-M. The FACT-M is scored on a 5 point Likert-scale: "Not at all", "A little bit", "Somewhat", "Quite a bit", and "Very much."
Measured: 3 years after inclusion
Description of the pathological response rates in the ILN
The pathologic response rate is categorized into pathologic complete response (pCR), near-pCR, major pathologic response (MPR), pathologic partial response (pPR), pathologic no response (pNR), according to International Neoadjuvant Melanoma Consortium (INMC) criteria.
Measured: 1 year after inclusion
Evaluation of the surgical morbidity, CTCAE v5
Description of the incidence and severity of post-surgical complications according to CTCAE v5
Measured: 2 year after inclusion
Evaluation of the surgical morbidity, Clavien Dindo
Description of the incidence and severity of post-surgical complications according to Clavien Dindo
Measured: 2 year after inclusion
Radiological evaluation of the index lymph node
Calculate Concordance rates between radiological and pathological response (pCR, pPR, pNR) in the ILN
Measured: 1 year after inclusion
Proportion of patients undergoing therapeutic lymph node dissection (TLND)
Description of the proportion of patients undergoing TLND stratified by MPR and non-MPR status
Measured: 5 years after inclusion
Melanoma specific survival
Description of the Melanoma specific survival, as calculated time from the date of start of neoadjuvant therapy to the date of death due to melanoma
Measured: 5 years after inclusion
Overall survival
Description of the overall survival, as calculated time from the date of start of neoadjuvant therapy to the date of death due to melanoma or any cause
Measured: 5 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start23 Apr 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Melanoma, SkinStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Omitting TLND in patients who achieve an MPR in the ILN following neoadjuvant ipilimumab and nivolumab.
- Masking
- None (open label)
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D.J. (Dirk) Grünhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, D.J. (Dirk) Grünhagen, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754904
- Sponsor's protocol ID
- NL88017.078.24
- Other IDs
- NL88017.078.24
- Acronym
- OMIT
- Status last verified
- Aug 2025
- First submitted
- 13 Dec 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have decided not to share de-identified individual participant data, as the dataset is intended for exclusive use by the primary research group. Sharing the data with researchers outside of this group is not aligned with the original goals and agreements of the study. Should there be a need for collaboration or data sharing in the future, we will evaluate this in consultation with the relevant parties.
Publications
Blank CU, Lucas MW, Scolyer RA, van de Wiel BA, Menzies AM, Lopez-Yurda M, Hoeijmakers LL, Saw RPM, Lijnsvelt JM, Maher NG, Pulleman SM, Gonzalez M, Torres Acosta A, van Houdt WJ, Lo SN, Kuijpers AMJ, Spillane A, Klop WMC, Pennington TE, Zuur CL, Shannon KF, Seinstra BA, Rawson RV, Haanen JBAG, Ch'ng S, Naipal KAT, Stretch J, van Thienen JV, Rtshiladze MA, Wilgenhof S, Kapoor R, Meerveld-Eggink A, Grijpink-Ongering LG, van Akkooi ACJ, Reijers ILM, Gyorki DE, Grunhagen DJ, Speetjens FM, Vliek SB, Placzke J, Spain L, Stassen RC, Amini-Adle M, Lebbe C, Faries MB, Robert C, Ascierto PA, van Rijn R, van den Berkmortel FWPJ, Piersma D, van der Westhuizen A, Vreugdenhil G, Aarts MJB, Stevense-den Boer MAM, Atkinson V, Khattak M, Andrews MC, van den Eertwegh AJM, Boers-Sonderen MJ, Hospers GAP, Carlino MS, de Groot JB, Kapiteijn E, Suijkerbuijk KPM, Rutkowski P, Sandhu S, van der Veldt AAM, Long GV. Neoadjuvant Nivolumab and Ipilimumab in Resectable Stage III Melanoma. N Engl J Med. 2024 Nov 7;391(18):1696-1708. doi: 10.1056/NEJMoa2402604. Epub 2024 Jun 2.
PubMed 38828984Reijers ILM, Menzies AM, van Akkooi ACJ, Versluis JM, van den Heuvel NMJ, Saw RPM, Pennington TE, Kapiteijn E, van der Veldt AAM, Suijkerbuijk KPM, Hospers GAP, Rozeman EA, Klop WMC, van Houdt WJ, Sikorska K, van der Hage JA, Grunhagen DJ, Wouters MW, Witkamp AJ, Zuur CL, Lijnsvelt JM, Torres Acosta A, Grijpink-Ongering LG, Gonzalez M, Jozwiak K, Bierman C, Shannon KF, Ch'ng S, Colebatch AJ, Spillane AJ, Haanen JBAG, Rawson RV, van de Wiel BA, van de Poll-Franse LV, Scolyer RA, Boekhout AH, Long GV, Blank CU. Personalized response-directed surgery and adjuvant therapy after neoadjuvant ipilimumab and nivolumab in high-risk stage III melanoma: the PRADO trial. Nat Med. 2022 Jun;28(6):1178-1188. doi: 10.1038/s41591-022-01851-x. Epub 2022 Jun 5.
PubMed 35661157
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OMIT Trial: Omitting Therapeutic Lymph Node Dissection in Patients With Stage IIIB/C Melanoma and Major Pathological Response in the Index Lymph Node After Neoadjudvant Immunotherapy
- ClinicalTrials.gov ID
- NCT06754904
- Acronym / sponsor ID
- OMIT / NL88017.078.24
- Conditions
- Melanoma, Skin
- Keywords
- Neoadjuvant, Ipilimumab, Nivolumab, Immunotherapy, Index node, Therapeutic lymph node dissection, Omitting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- D.J. (Dirk) GrünhagenUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2032 (estimated)
- First posted
- 1 Jan 2025 (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.
Rationale: The randomized trial NADINA has demonstrated that neoadjuvant treatment with nivolumab with ipilimumab improves event-free survival (EFS) in patients with macroscopic resectable stage III melanoma. In this study, therapeutic lymph node dissection (TLND) was standard of care, showing that patients achieving a major pathological response (MPR, i.e., ≤10% residual viable tumor bed) have an excellent outcome (EFS and Distant Metastasis Free Survival (DMFS)). The PRADO trial indicated that the MPR definition can also be revealed from a surrogate lymph node response, the index lymph node (ILN), allowing sparing the extensive surgery in MPR patients. In these MPR patients the DMFS was 100% after 1 year and 98% after 2 years, and recurrence-free survival (RFS) was 95% after 1 year and 93% after 2 years. Given that TLND is associated with morbidity and has a significant impact on health-related quality of life (HR-QoL) and healthcare costs, this study aims to prospectively investigate the safety of omitting TLND in patients who have an MPR within the ILN after neoadjuvant immunotherapy.
Objectives: To investigate whether TLND can be safely omitted in patients with macroscopic resectable stage III (B/C/D) melanoma achieving an MPR within the ILN upon neoadjuvant treatment with immune checkpoint inhibitors (ipilimumab and nivolumab).
Study design: This study is a prospective, single-arm phase 2 nationwide multicenter trial.
Study population:
Inclusion criteria for study participants are as follows:
- Patients must be eligible for neoadjuvant treatment
- Patients must have a histologically confirmed diagnosis of macroscopic resectable stage III melanoma (stage III B/C/D) with one or more macroscopic lymph node metastasis
- The patient must have a measurable tumor burden that qualifies (according to clinical practice) for neoadjuvant therapy
Intervention: Omitting TLND in patients who achieve an MPR in the ILN following neoadjuvant ipilimumab and nivolumab.
Main study endpoints: The two coprimary endpoints are 2-year Local Recurrence Free Survival (LRFS) and 2-year DMFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Omitting TLND in patients who achieve an MPR in the ILN following neoadjuvant ipilimumab and nivolumab.
| Arm | Type | Receives |
|---|---|---|
| Omitting TLND | Experimental | Procedure: Omitting TLND, Procedure: Index node procedureOmitting TLND in patients who achieve an MPR in the ILN following neoadjuvant ipilimumab and nivolumab. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must be eligible for neoadjuvant treatment (ipilimumab and nivolumab)
- Patients must be 16 years of age or older.
- Patients must have a histologically confirmed diagnosis of macroscopic resectable stage III melanoma (stage III B/C/D) with one or more macroscopic lymph node metastase defined as either one:
- a palpable node, confirmed as melanoma by pathology; a non-palpable but enlarged lymph node according to RECISTv1.1 (at least 15 mm in short axis), confirmed as melanoma by pathology;
- a PET scan positive lymph node of any size confirmed as melanoma by pathology;
Key exclusion criteria (6 listed)
- Uveal/ocular or mucosal melanoma
- WHO performance status of two or more
- In-transit metastases only (without cytological or histological proven lymph node involvement)
- Prior targeted therapy targeting BRAF and/or MEK for melanoma
- Prior immunotherapy targeting CTLA-4, PD-1 or PD-L1 for melanoma
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 |
|---|---|---|
| Omitting TLNDOmitting TLND in patients who achieve an MPR in the index node following neoadjuvant ipilimumab and nivolumab. | Procedure or surgery | Omitting TLND |
| Index node procedureIndex node procedure | Procedure or surgery | Omitting TLND |
Primary outcome
Local Recurrence Free Survival (LRFS)
Time frame: 2 years after inclusion
LRFS, as defined as time from removal of the index lymph node (ILN) until local (in basin) recurrence in the MPR group. Accepting a local relapse of 20%.
Distant Metastasis Free Survival (DMFS)
Time frame: 2 years after inclusion
DMFS assessed in the MPR group, as defined as time from the start of neoadjuvant immunotherapy, nivolumab with ipilimumab, until the first occurrence of distant metastasis. Accepting DMFS 3% lower than the 2 years DMFS of the NADINA trial
9 secondary outcomes
Evaluation of health-related quality of life (HRQoL), EORTC QLQ C30
Time frame: 3 years after inclusion
Evaluation of health-related quality of life (HRQoL), FACT-M
Time frame: 3 years after inclusion
Description of the pathological response rates in the ILN
Time frame: 1 year after inclusion
Evaluation of the surgical morbidity, CTCAE v5
Time frame: 2 year after inclusion
Evaluation of the surgical morbidity, Clavien Dindo
Time frame: 2 year after inclusion
Radiological evaluation of the index lymph node
Time frame: 1 year after inclusion
Proportion of patients undergoing therapeutic lymph node dissection (TLND)
Time frame: 5 years after inclusion
Melanoma specific survival
Time frame: 5 years after inclusion
Overall survival
Time frame: 5 years after inclusion
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 7 Aug 2025.
- Background: PubMed 38828984Blank CU, Lucas MW, Scolyer RA, van de Wiel BA, Menzies AM, Lopez-Yurda M, Hoeijmakers LL, Saw RPM, Lijnsvelt JM, Maher NG, Pulleman SM, Gonzalez M, Torres Acosta A, van Houdt WJ, Lo SN, Kuijpers AMJ, Spillane A, Klop WMC, Pennington TE, Zuur CL, Shannon KF, Seinstra BA, Rawson RV, Haanen JBAG, Ch'ng S, Naipal KAT, Stretch J, van Thienen JV, Rtshiladze MA, Wilgenhof S, Kapoor R, Meerveld-Eggink A, Grijpink-Ongering LG, van Akkooi ACJ, Reijers ILM, Gyorki DE, Grunhagen DJ, Speetjens FM, Vliek SB, Placzke J, Spain L, Stassen RC, Amini-Adle M, Lebbe C, Faries MB, Robert C, Ascierto PA, van Rijn R, van den Berkmortel FWPJ, Piersma D, van der Westhuizen A, Vreugdenhil G, Aarts MJB, Stevense-den Boer MAM, Atkinson V, Khattak M, Andrews MC, van den Eertwegh AJM, Boers-Sonderen MJ, Hospers GAP, Carlino MS, de Groot JB, Kapiteijn E, Suijkerbuijk KPM, Rutkowski P, Sandhu S, van der Veldt AAM, Long GV. Neoadjuvant Nivolumab and Ipilimumab in Resectable Stage III Melanoma. N Engl J Med. 2024 Nov 7;391(18):1696-1708. doi: 10.1056/NEJMoa2402604. Epub 2024 Jun 2.
- Background: PubMed 35661157Reijers ILM, Menzies AM, van Akkooi ACJ, Versluis JM, van den Heuvel NMJ, Saw RPM, Pennington TE, Kapiteijn E, van der Veldt AAM, Suijkerbuijk KPM, Hospers GAP, Rozeman EA, Klop WMC, van Houdt WJ, Sikorska K, van der Hage JA, Grunhagen DJ, Wouters MW, Witkamp AJ, Zuur CL, Lijnsvelt JM, Torres Acosta A, Grijpink-Ongering LG, Gonzalez M, Jozwiak K, Bierman C, Shannon KF, Ch'ng S, Colebatch AJ, Spillane AJ, Haanen JBAG, Rawson RV, van de Wiel BA, van de Poll-Franse LV, Scolyer RA, Boekhout AH, Long GV, Blank CU. Personalized response-directed surgery and adjuvant therapy after neoadjuvant ipilimumab and nivolumab in high-risk stage III melanoma: the PRADO trial. Nat Med. 2022 Jun;28(6):1178-1188. doi: 10.1038/s41591-022-01851-x. Epub 2022 Jun 5.
- Individual participant dataSharing planned: No. We have decided not to share de-identified individual participant data, as the dataset is intended for exclusive use by the primary research group. Sharing the data with researchers outside of this group is not aligned with the original goals and agreements of the study. Should there be a need for collaboration or data sharing in the future, we will evaluate this in consultation with the relevant parties.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omitting TLND and Index node procedure in people with Melanoma, Skin, run by D.J. (Dirk) Grünhagen at 1 site in Netherlands.
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 8 inclusion and 6 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 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 Drik Grünhagen, MD, PhD (+31 10 704 19 02, d.grunhagen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Recurrence Free Survival (LRFS) (time frame: 2 years after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06754904, which also lists 2 linked publications.
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 7 Aug 2025.