NCT04042116

A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor

LIO-1: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With An Advanced, Metastatic Solid Tumor

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 227 (estimated)
• Sponsor: Clovis Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, Phase 1b/2 study to determine the recommended dose of lucitanib in combination with nivolumab in patients with an advanced solid tumor (Phase 1b); followed by evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced gynecological solid tumor (Phase 2) and evaluate the effects of dosing under fasting or fed state (Food Effect)

Conditions

• Advanced Solid Tumor
• Gynecologic Cancer

Interventions

Type	Name	Description
DRUG	Lucitanib	Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
DRUG	Lucitanib	Oral lucitanib will be administered once daily (QD). The dose will be 6 mg.
DRUG	Lucitanib	Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg. Subjects will be allowed to intrapatient dose escalate in increments of 2 mg up to a total dose of 10 mg QD lucitanib if they meet the study specific clinical criteria.
DRUG	Nivolumab	IV nivolumab 480 mg will be administered once every 4 weeks.

Timeline

• Start date: 2019-07-29
• Primary completion: 2023-07-01
• Completion: 2024-01-01
• First posted: 2019-08-01
• Last updated: 2022-12-20

Locations

27 sites across 6 countries: United States, Austria, Belgium, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study