NCT04410445

Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence

A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 765 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.

Detailed 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/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.

Conditions

• Melanoma
• Melanoma Stage III
• Melanoma Stage IV
• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	Bempegaldesleukin	Specified dose on specified days
BIOLOGICAL	Nivolumab	Specified dose on specified days

Timeline

• Start date: 2020-07-27
• Primary completion: 2022-09-22
• Completion: 2022-09-22
• First posted: 2020-06-01
• Last updated: 2023-04-21
• Results posted: 2023-04-21

Locations

212 sites across 17 countries: United States, Australia, Austria, Czechia, France, Germany, Greece, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study