NCT02799095

A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors

A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Mural Oncology, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To better understand the safety and tolerability of ALKS 4230 in humans

Detailed description

To investigate the safety and tolerability of ALKS 4230, determine the recommended Phase 2 dose (RP2D) and assess anti-tumor activity in Monotherapy and ALKS 4230 in Combination with pembrolizumab.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ALKS 4230	Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period
DRUG	ALKS 4230 + pembrolizumab	IV infusion of ALKS 4230 over 30 minutes given daily for 5 consecutive days followed by an off-treatment period; pembrolizumab administered IV once with ALKS 4230 on the first day of each cycle

Timeline

• Start date: 2016-09-14
• Primary completion: 2023-03-27
• Completion: 2023-08-02
• First posted: 2016-06-14
• Last updated: 2025-05-21
• Results posted: 2025-05-21

Locations

31 sites across 7 countries: United States, Australia, Belgium, Canada, Poland, South Korea, Spain