Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Melanoma
  • Melanoma (Skin)
  • Melanoma Stage III
  • Melanoma Stage IV
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be randomized in a 1:1 ratio to one of two treatment armsMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 12 years and 125 years
Gender
Both males and females

Description

The main purpose of this study is to compare the efficacy, as measured by recurrence-free survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph node [LN] metastasis > 1 mm), Stage IIIB/...

The main purpose of this study is to compare the efficacy, as measured by recurrence-free survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph node [LN] metastasis > 1 mm), Stage IIIB/C/D, or Stage IV (American Joint Committee on Cancer [AJCC] 8th edition) cutaneous melanoma with no evidence of disease (NED) who are at high risk for recurrence.

Tracking Information

NCT #
NCT04410445
Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Mann Muhsin, MD Nektar Therapeutics