NCT05092360

Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)

A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: Mural Oncology, Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multicenter, open-label, randomized study of nemvaleukin in combination with pembrolizumab versus protocol-specific Investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Detailed description

Patients will be centrally allocated in a randomized fashion (3:1:1:3) to receive either: Arm 1: Nemvaleukin and pembrolizumab combination therapy Arm 2: Pembrolizumab monotherapy Arm 3: Nemvaleukin monotherapy Arm 4: Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.

Conditions

• Platinum-resistant Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Nemvaleukin and Pembrolizumab Combination	Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes and Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
BIOLOGICAL	Pembrolizumab	Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
BIOLOGICAL	Nemvaleukin	Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes
DRUG	Pegylated Liposomal Doxorubicin (PLD)	40 mg/m2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+)
DRUG	Paclitaxel	80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min
DRUG	Topotecan	4 mg/m2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min
DRUG	Gemcitabine	1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min

Timeline

• Start date: 2022-01-10
• Primary completion: 2025-01-08
• Completion: 2025-05-08
• First posted: 2021-10-25
• Last updated: 2025-08-28
• Results posted: 2025-08-28

Locations

117 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Italy, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study