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

NCT05092360 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2025-08-28

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Mural Oncology Medical Monitor · Mural Oncology, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2025-01-08
Completion
2025-05-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05092360 on ClinicalTrials.gov