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
Phase 2
Withdrawn
- Conditions
- Melanoma
- Interventions
- Biological: NivolumabBiological: Ipilimumab
- Registration Number
- NCT04495010
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adjuvant treatment Nivolumab - Neoadjuvant treatment + Adjuvant treatment Nivolumab - Neo treat with patho response-driven Adju treat or observation Nivolumab Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation Neoadjuvant treatment + Adjuvant treatment Ipilimumab - Neo treat with patho response-driven Adju treat or observation Ipilimumab Neoadjuvant treatment with pathologic response-driven Adjuvant treatment or observation
- Primary Outcome Measures
Name Time Method Event-free survival (EFS) Up to 4 years
- Secondary Outcome Measures
Name Time Method Recurrence-free survival (RFS) Time from Surgery Up to 5 years RFS by MPR Up to 5 years RFS Time from Adjuvant Therapy Up to 5 years Incidence of Adverse Events (AEs) Up to 5 years Incidence of deaths Up to 5 years Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to 5 years Incidence of Serious Adverse Events (SAEs) Up to 5 years Pathologic response rate (pRR) by immune-related pathologic response (irPR) Up to 5 years Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests Up to 5 years Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Up to 5 years Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS) Up to 5 years Concordance major pathologic response (MPR) by local and central pathology Review Up to 5 years MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR
Trial Locations
- Locations (1)
Local Institution
🇬🇧Sutton, United Kingdom