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Withdrawn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

• 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

Study Timeline

• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-07-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19
• Study Start: 2021-03-31
• Primary Completion: 2024-02-28
• Study Completion: 2027-10-23

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• Status: WITHDRAWN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

Primary Outcome Measures

Name	Time	Method
Event-free survival (EFS)	Up to 4 years

Secondary Outcome Measures

Name	Time	Method
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
RFS by MPR	Up to 5 years
Incidence of Serious Adverse Events (SAEs)	Up to 5 years
Recurrence-free survival (RFS) Time from Surgery	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