NCT04495010

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma

Interventions

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

Timeline

• Start date: 2021-03-31
• Primary completion: 2024-02-28
• Completion: 2027-10-23
• First posted: 2020-07-31
• Last updated: 2021-03-19

Locations

118 sites across 16 countries: United States, Australia, Austria, Belgium, Brazil, Denmark, France, Germany, Italy, Netherlands, Poland, Russia, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study