Melanoma (Skin Cancer)Phase 2NCT07740941
NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB-IV (M1a) Melanoma
A Phase 2 study testing Pembrolizumab and Ipilimumab plus nivolumab in people with Melanoma (Skin Cancer) and Melanoma Stage Stage IIIB, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study evaluates the impact of neoadjuvant Programmed cell death Protein 1 (PD-1)-based treatment regimens in patients with resectable stage IIIB-M1a cutaneous or unknown primary melanoma at high risk of relapse without adjuvant therapy after definitive lymphadenectomy and irrespective of pathologic response… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin Cancer), Melanoma Stage Stage IIIB, Melanoma Stage M1
- What is being tested?
- Pembrolizumab and Ipilimumab plus nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2026to Mar 2029
- 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
- Written informed consent will be obtained to participate in the study, and HIPAA authorization for the release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee, including randomization.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-2.
- Histological confirmation of cutaneous melanoma or melanoma of unknown primary.
- AJCC stage IIIB/IVa resectable disease that is measurable by iRECIST criteria.
- Adequate hematologic, renal, hepatic, and heart function
Who cannot join
- Prior treatment with PD-1 Programmed cell death Protein 1 (PD-1) and Cytotoxic T-lymphocyte Antigen 4 (CTLA-4).
- Has an active autoimmune disease that requires systemic treatment with the use of disease-modifying agents or immunosuppressive drugs. For corticosteroids, up to 10 mg of prednisone daily, or an equivalent dose, is permitted. Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Any condition, including laboratory abnormalities, that, in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illnesses that are likely to interfere with participation in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Claire Kowalczyk, 919-984-0000, claire_kowalczyk@med.unc.edu
Alexandra V Romfoe, 919-984-0000, alexandra_romfoe@med.unc.edu
About this study
Official title: NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB- IV (M1a) Melanoma
This study evaluates the impact of neoadjuvant Programmed cell death Protein 1 (PD-1)-based treatment regimens in patients with resectable stage IIIB-M1a cutaneous or unknown primary melanoma at high risk of relapse without adjuvant therapy after definitive lymphadenectomy and irrespective of pathologic response outcome on the 2-year overall survival (OS). It was hypothesized that neoadjuvant PD1 inhibitor-based treatment without adjuvant treatment does not significantly (non-inferior) impact OS in this study patient population. Patients will be randomized to either two infusions of pembrolizumab or one infusion of ipilimumab plus nivolumab followed by a single infusion of nivolumab. Patients will undergo follow-up and restaging scans to assess event-free survival at 12 months and OS at 24 months after the first neoadjuvant treatment infusion.
- Being tested
- Pembrolizumab, Ipilimumab plus nivolumab
- Keywords
- Programmed cell death Protein 1 inhibitor, pembrolizume, ipilimumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Pembrolizumab 200 mg IV, every 3 weeks
Ipilimumab plus nivolumabDrug
Single infusion of concurrent ipilimumab (3 mg/kg) plus nivolumab (1 mg/kg) followed by a single infusion of nivolumab 240 mg IV 3 weeks later
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Participants receive pembrolizumab 200 mg IV, every 3 weeks, times 2 infusions followed by lymph node dissection, followed by no adjuvant treatment. Receives: Drug: Pembrolizumab |
| Arm B | Experimental | Participants receive ipilimumab (3 mg/kg) plus nivolumab (1 mg/kg) x one infusion, followed by a single infusion of nivolumab 240 mg IV 3 weeks later, followed by lymph node dissection, followed by no adjuvant treatment Receives: Drug: Ipilimumab plus nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The overall survival (OS) rate will be defined from the initiation of study treatments for the combined patient cohorts (cohort A and cohort B).
Measured: 2-year
Secondary outcomes (3)
Event - Free Survival (EFS)
The Event - Free Survival (EFS) rate will be defined from the initiation of study treatments for the combined patient cohorts (cohort A and cohort B).
Measured: 1-year
Major pathologic response (MPR) rate
The MPR rate for each of the two study treatment cohorts (cohort A and cohort B) will be defined using established pathologic response criteria. Pathologic response will be assessed by determining the percentage of residual viable tumor in the resected specimen. Major pathologic response is defined as ≤10% residual viable tumor, and pathologic complete response is defined as the absence of viable tumor cells.
Measured: Up to 12 weeks
Treatment Related Adverse Events (TRAEs)
TRAEs are defined as adverse events assessed by the investigator as related to study treatment, Grade 3 or higher grades. The incidence of TRAEs will be determined separately for each of the two cohorts and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 6.0. CTCAE classifies severity as follows: Grade 1 - asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 - minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3 - severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 - life-threatening consequences; urgent intervention indicated. Grade 5 - death related to the adverse event.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start6 Aug 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive 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
- Model description
- Assignment, non-inferiority assessment. Allocation: Randomized1:1
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stergios Moschos, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740941
- Sponsor's protocol ID
- LCCC2510
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2026
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB- IV (M1a) Melanoma
- ClinicalTrials.gov ID
- NCT07740941
- Acronym / sponsor ID
- LCCC2510
- Keywords
- Programmed cell death Protein 1 inhibitor, pembrolizume, ipilimumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 3 Aug 2026 (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 study evaluates the impact of neoadjuvant Programmed cell death Protein 1 (PD-1)-based treatment regimens in patients with resectable stage IIIB-M1a cutaneous or unknown primary melanoma at high risk of relapse without adjuvant therapy after definitive lymphadenectomy and irrespective of pathologic response outcome on the 2-year overall survival (OS). It was hypothesized that neoadjuvant PD1 inhibitor-based treatment without adjuvant treatment does not significantly (non-inferior) impact OS in this study patient population. Patients will be randomized to either two infusions of pembrolizumab or one infusion of ipilimumab plus nivolumab followed by a single infusion of nivolumab. Patients will undergo follow-up and restaging scans to assess event-free survival at 12 months and OS at 24 months after the first neoadjuvant treatment infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Assignment, non-inferiority assessment. Allocation: Randomized1:1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: PembrolizumabParticipants receive pembrolizumab 200 mg IV, every 3 weeks, times 2 infusions followed by lymph node dissection, followed by no adjuvant treatment. |
| Arm B | Experimental | Drug: Ipilimumab plus nivolumabParticipants receive ipilimumab (3 mg/kg) plus nivolumab (1 mg/kg) x one infusion, followed by a single infusion of nivolumab 240 mg IV 3 weeks later, followed by lymph node dissection, followed by no adjuvant treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent will be obtained to participate in the study, and HIPAA authorization for the release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee, including randomization.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-2.
- Histological confirmation of cutaneous melanoma or melanoma of unknown primary.
Key exclusion criteria (3 listed)
- Prior treatment with PD-1 Programmed cell death Protein 1 (PD-1) and Cytotoxic T-lymphocyte Antigen 4 (CTLA-4).
- Has an active autoimmune disease that requires systemic treatment with the use of disease-modifying agents or immunosuppressive drugs. For corticosteroids, up to 10 mg of prednisone daily, or an equivalent dose, is permitted. Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Any condition, including laboratory abnormalities, that, in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illnesses that are likely to interfere with participation in this clinical 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 |
|---|---|---|
| PembrolizumabPembrolizumab 200 mg IV, every 3 weeks | Drug | Arm A |
| Ipilimumab plus nivolumabSingle infusion of concurrent ipilimumab (3 mg/kg) plus nivolumab (1 mg/kg) followed by a single infusion of nivolumab 240 mg IV 3 weeks later | Drug | Arm B |
Primary outcome
Overall survival
Time frame: 2-year
The overall survival (OS) rate will be defined from the initiation of study treatments for the combined patient cohorts (cohort A and cohort B).
3 secondary outcomes
Event - Free Survival (EFS)
Time frame: 1-year
Major pathologic response (MPR) rate
Time frame: Up to 12 weeks
Treatment Related Adverse Events (TRAEs)
Time frame: Up to 12 weeks
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 30 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink 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.
Stergios Moschos, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab and Ipilimumab plus nivolumab in people with Melanoma (Skin Cancer) and Melanoma Stage Stage IIIB, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 7 inclusion and 3 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 30 Sep 2026. 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 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 Claire Kowalczyk (919-984-0000, claire_kowalczyk@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2-year). 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 30 Sep 2026.