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

Bristol-Myers Squibb1 site in 1 countryMarch 31, 2021

ConditionsMelanoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Locations: 1
Primary Endpoint: Event-free survival (EFS)
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 31, 2021

End Date

October 23, 2027

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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
•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

Outcomes

Primary Outcomes

Event-free survival (EFS)

Time Frame: Up to 4 years

Secondary Outcomes

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)