Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Melanoma
- Melanoma Stage III
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Subjects with Stage III resectable melanoma will receive one dose of nivolumab 480 mg IV, then undergo standard definitive surgery approximately 4 weeks after the initial dose of nivolumab. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab 480 mg IV...
Subjects with Stage III resectable melanoma will receive one dose of nivolumab 480 mg IV, then undergo standard definitive surgery approximately 4 weeks after the initial dose of nivolumab. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab 480 mg IV every 4 weeks or ipilimumab plus nivolumab, as determined by pathologic response at the time of resection. Subjects with pathologic complete response or near pathologic complete response (PathCR/nearCR) (Arm A) receive adjuvant nivolumab for up to one year. Subjects with <PathCR/nearCR are randomized 1:2 to either adjuvant nivolumab (480 mg) for up to one year (Arm B) or adjuvant ipilimumab (1mg/kg) plus nivolumab (3mg/kg) for 4 doses and then nivolumab (480 mg) alone for a total of one year (Arm C).
Tracking Information
- NCT #
- NCT04013854
- Collaborators
- Not Provided
- Investigators
- Not Provided