NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB-IV (M1a) Melanoma

NCT07740941 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LCCC2510
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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 outcome on the 2-year overall survival (OS). We hypothesize 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.

Conditions

Melanoma (Skin Cancer); Melanoma Stage Stage IIIB; Melanoma Stage M1; Melanoma Stage IV

Keywords

Programmed cell death Protein 1 inhibitor; pembrolizume; ipilimumab

Outcome Measures

Primary Outcomes (1)

• 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).

  2-year

Secondary Outcomes (3)

• Event - Free Survival (EFS)

  1-year

• Major pathologic response (MPR) rate

  Up to 12 weeks

• Treatment Related Adverse Events (TRAEs)

  Up to 12 weeks

Study Arms (2)

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.

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

Drug: Ipilimumab plus nivolumab

Interventions

Pembrolizumab DRUG

Pembrolizumab 200 mg IV, every 3 weeks

Arm A

Ipilimumab plus nivolumab DRUG

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

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab; Ipilimumab; Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Stergios Moschos, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Kowalczyk

CONTACT

919-984-0000; claire_kowalczyk@med.unc.edu

Alexandra V Romfoe

CONTACT

919-984-0000; alexandra_romfoe@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Assignment, non-inferiority assessment. Allocation: Randomized1:1

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

US (1)