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

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513230-38-00

Acronym

ALKS 4230-007

Enrollment

244

Registered

2024-09-04

Start date

2022-12-15

Completion date

2025-05-09

Last updated

2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube, or Primary Peritoneal Cancer, Platinum-Resistant Epithelial Ovarian

Brief summary

Overall survival (OS)

Detailed description

1. Progression-free survival (PFS) as assessed by Investigator, based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, 2. Objective response rate (ORR) as assessed by Investigator, based on RECIST v1.1, 3. Disease control rate (DCR), duration of response (DOR), and time to response (TTR) as assessed by Investigator, based on RECIST v1.1, 4. Cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG), 5. Safety as assessed by treatment-emergent adverse events (TEAEs), clinical laboratory parameters, vital signs, and electrocardiograms (ECGs)

Interventions

DRUGTOPOTECAN HYDROCHLORIDE

DRUGDOXORUBICIN HYDROCHLORIDE

DRUGPACLITAXEL

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGNEMVALEUKIN ALFA

DRUGGEMCITABINE HYDROCHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	—

Secondary

Measure	Time frame
1. Progression-free survival (PFS) as assessed by Investigator, based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, 2. Objective response rate (ORR) as assessed by Investigator, based on RECIST v1.1, 3. Disease control rate (DCR), duration of response (DOR), and time to response (TTR) as assessed by Investigator, based on RECIST v1.1, 4. Cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG), 5. Safety as assessed by treatment-emergent adverse events (TEAEs), clinical laboratory parameters, vital signs, and electrocardiograms (ECGs)	—

Measure

Time frame

—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Italy, Lithuania, Norway, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026