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Not yet recruiting NCT07740941

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

Phase II Interventional Melanoma (Skin Cancer) Melanoma Stage Stage IIIB Melanoma Stage M1 Melanoma Stage IV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pembrolizumab, Ipilimumab plus nivolumab.
Who it may be relevant to
Registry conditions: Melanoma (Skin Cancer), Melanoma Stage Stage IIIB, Melanoma Stage M1, Melanoma Stage IV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Pembrolizumab
    Pembrolizumab 200 mg IV, every 3 weeks
  • Drug 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 measures

  • Overall survival [Time frame: 2-year]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Lineberger Comprehensive Cancer Center — Chapel Hill

Identifiers

NCT: NCT07740941 · LCCC2510

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗