Recruiting
Phase 2

Pembrolizumab & Nivolumab

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07740941

Conditions

Melanoma (Skin Cancer)

Melanoma Stage Stage IIIB

Melanoma Stage M1

Melanoma Stage IV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Ipilimumab plus nivolumab

Study Details

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). 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.

Conditions

Melanoma (Skin Cancer)

Melanoma Stage Stage IIIB

Melanoma Stage M1

Melanoma Stage IV

Study ID

NCT07740941

Start date

Aug 6, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Participants receive pembrolizumab 200 mg IV, every 3 weeks, times 2 infusions followed by lymph node dissection, followed by no adjuvant treatment.

experimental: Arm B

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

Interventions

Pembrolizumab

Pembrolizumab 200 mg IV, every 3 weeks

Ipilimumab plus nivolumab

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

Primary outcome measure

  • Overall survival [ Time Frame: 2-year ]

Central Contacts and Locations

Central contacts

Claire Kowalczyk

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

Alexandra V Romfoe

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

Locations

Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Claire Kowalczyk

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

Alexandra V Romfoe

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

Principal Investigator:

Stergios Moschos, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

  • Programmed cell death Protein 1 inhibitor
  • pembrolizume
  • ipilimumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.