CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 243 enrolled
Drug / intervention
ALKS 4230 +1 moredrug
Likely dose
ALKS 4230 IV infusion over 30 minutes daily for 5 consecutive days per cycle; pembrolizumab IV once on Day 1 of each cycle (combination arm)AI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed solid tumor (melanoma or RCC for Part B/C)
  • ✓Advanced disease refractory to or intolerant of standard therapies
  • ✓At least 1 measurable target lesion (Part B/C)
  • ✓ECOG performance status 0 or 1
Key exclusion· 11
  • ✕Active or symptomatic CNS metastases (treated/stable lesions allowed)
  • ✕Active infection or fever ≥38.5°C within 3 days of treatment start
  • ✕QTc prolongation (>470 msec in females, >450 msec in males)
  • ✕Known hypersensitivity to ALKS 4230 or pembrolizumab

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02799095
NCT02799095Phase 2Completed
CompareCT.gov

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

Mural Oncology, Inc·interventional·Posted Jun 14, 2016·Updated May 21, 2025

In Brief

A Phase 2 clinical trial evaluating ALKS 4230 and ALKS 4230 + pembrolizumab for Advanced Solid Tumors. Completed, enrolled 243 participants across 31 sites in 7 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesAustralia, Belgium, Canada, Poland, South Korea, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 14, 2016
Enrollment StartSep 14, 2016
Primary CompletionMar 27, 2023
Study CompletionAug 2, 2023
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 10.0 years ago

Interventions

ALKS 4230drug

Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period

ALKS 4230 + pembrolizumabdrug

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