NCT02723006

Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma

An Open-Label, Phase 1b, Multi-Arm Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Patients With Advanced Melanoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the initial safety profile and initial antitumor activity of the combination treatments (immune checkpoint inhibitors \[nivolumab, ipilimumab\] with investigational drugs \[TAK-580, TAK-202 (plozalizumab), vedolizumab\]) in the 3 arms when administered to participants with advanced melanoma.

Detailed description

The drugs being tested in this study are called TAK-580, TAK-202 (plozalizumab), and vedolizumab. These investigational drugs were given along with standard of care checkpoint inhibitors (\[nivolumab in Arms 1 and 2\] or nivolumab + ipilimumab in Arm 3). This study looked at the safety profile of the combination treatments in each arm when administered to participants with metastatic melanoma. The study planned to enroll approximately 156 participants. Participants were assigned to one of the 3 treatment groups: * TAK-580 + nivolumab * TAK-202 (plozalizumab) + nivolumab * vedolizumab + nivolumab + ipilimumab This study consists of 3 parts. A dose-escalation safety lead-in phase, confirmatory safety phase and a cohort expansion phase. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 50 weeks. Participants may make multiple visits to the clinic and 30, 60, and 90 days after last dose of study drug for follow-up assessments.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	TAK-580	TAK-580 tablets
DRUG	TAK-202	TAK-202 infusion
DRUG	vedolizumab	vedolizumab infusion
DRUG	nivolumab	nivolumab infusion
DRUG	ipilimumab	ipilimumab infusion

Timeline

• Start date: 2016-06-22
• Primary completion: 2018-05-11
• Completion: 2018-05-11
• First posted: 2016-03-30
• Last updated: 2024-03-05
• Results posted: 2021-04-01

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study