Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma Participants

Overview

The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.

Full Title of Study: “A Phase 2, Randomized Study of Neoadjuvant Nivolumab Plus Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab Plus Ipilimumab Followed by Either Adjuvant Nivolumab or Postsurgical Observation Depending on Pathologic Response Compared With Adjuvant Nivolumab in Treatment-Naive Patients With Resectable Clinically Detectable Stage III Melanoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2024

Interventions

  • Biological: Nivolumab
    • Specified dose on specified days
  • Biological: Ipilimumab
    • Specified dose on specified days

Arms, Groups and Cohorts

  • Experimental: Neoadjuvant treatment + Adjuvant treatment
  • Experimental: Adjuvant treatment
  • Experimental: Neo treat with patho response-driven Adju treat or observation
    • Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation

Clinical Trial Outcome Measures

Primary Measures

  • Event-free survival (EFS)
    • Time Frame: Up to 4 years

Secondary Measures

  • Recurrence-free survival (RFS) Time from Surgery
    • Time Frame: Up to 5 years
  • RFS Time from Adjuvant Therapy
    • Time Frame: Up to 5 years
  • Pathologic response rate (pRR) by immune-related pathologic response (irPR)
    • Time Frame: Up to 5 years
  • Concordance major pathologic response (MPR) by local and central pathology Review
    • Time Frame: Up to 5 years
    • MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR
  • RFS by MPR
    • Time Frame: Up to 5 years
  • Incidence of Adverse Events (AEs)
    • Time Frame: Up to 5 years
  • Incidence of Serious Adverse Events (SAEs)
    • Time Frame: Up to 5 years
  • Incidence of deaths
    • Time Frame: Up to 5 years
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests
    • Time Frame: Up to 5 years
  • Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
    • Time Frame: Up to 5 years
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
    • Time Frame: Up to 5 years
  • Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS)
    • Time Frame: Up to 5 years

Participating in This Clinical Trial

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria

  • Males and females, ≥ 12 years of age [Except: where local regulations and/or institutional policies do not allow for participants < 18 years of age (adolescent population) to participate. For those sites, the eligible participant population is 18 years of age or local age of majority, inclusive]
  • Diagnosed with cytologically or histologically confirmed Stage IIIB, IIIC, or IIID cutaneous melanoma as per American Joint Committee on Cancer (AJCC) staging system, with ≥ 1 clinically detectable lymph node metastases (N1b, N2b, N3b), which are measurable according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
  • Adult participants and adolescents 16 to 18 years old must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1. Adolescents < 16 years old must have Lanksky Play-Performance Status scale performance of ≥ 60
  • Must be treatment-naïve (ie, no prior systemic anticancer therapy as adjuvant therapy for melanoma or unresectable/metastatic melanoma)
  • Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria

  • Women who are breastfeeding
  • Patients with serious or uncontrolled medical disorders
  • Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol-defined inclusion/exclusion criteria apply

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb
  • Overall Contact(s)
    • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,, please email:, Clinical.Trials@bms.com

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