NCT01621490

PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma

An Exploratory Study of the Biologic Effects of Nivolumab and Ipilimumab Monotherapy and Nivolumab in Combination With Ipilimumab Treatment in Subjects With Advanced Melanoma (Unresectable or Metastatic)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced)

Detailed description

Allocation: Part 1 and 2: Single Arm study Part 3 and 4: Randomized Controlled Trial Intervention Model: Part 1 and 2: Single group: Single arm study Part 3 and 4: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study Minimum Age: Part 1: 18 Part 2, 3 and 4: 16

Conditions

• Advanced Melanoma
• Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab
DRUG	Ipilimumab

Timeline

• Start date: 2012-09-27
• Primary completion: 2017-09-12
• Completion: 2018-10-25
• First posted: 2012-06-18
• Last updated: 2024-04-23
• Results posted: 2019-12-03

Locations

14 sites across 3 countries: United States, Netherlands, Spain

Regulatory

• FDA-regulated drug study