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

August 11, 2025 updated by: Mural Oncology, Inc

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

456

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Cancer Research SA
      • Blacktown, Australia, 2148
        • Blacktown Hospital
      • Brisbane, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • East Melbourne, Australia, 3184
        • Epworth Healthcare
      • Garran, Australia, 2605
        • Canberra Hospital
      • South Brisbane, Australia, 4066
        • Icon Cancer Centre
      • Wollongong, Australia, 2500
        • Wollongong Hospital (Illawarra Shoalhaven Local Health District)
  • Austria
      • Feldkirch, Austria, 6800
        • LKH Feldkirch
      • Graz, Austria, 8036
        • Medizinische Universitaet Graz
      • Innsbruck, Austria, 6020
        • Medizinische Universitaet Innsbruck
      • Vienna, Austria, 1090
        • Medizinische Universitaet Wien
      • Vienna, Austria, 1130
        • Wiener Gesundheitsverbund - Klinik Hietzing
  • Belgium
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc
      • Brussels, Belgium, 1000
        • CHU Saint-Pierre
      • Liège, Belgium, 4000
        • Clinique CHC MontLégia
      • Ostend, Belgium, 8400
        • AZ Damiaan
      • Roeselare, Belgium, 8800
        • AZ Delta
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universite de Sherbrooke (CHUS)
  • Czechia
      • Brno, Czechia, 65653
        • Masarykuv onkologicky ustav
      • Prague, Czechia, 12808
        • Vseobecna fakultni nemocnice v Praze
      • Prague, Czechia, 181 00
        • Fakultni nemocnice Bulovka
  • France
      • Angers, France, 49055
        • Institut de Cancérologie de l'Ouest - Site Angers
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Marseille, France, 13009
        • Institut Paoli-Calmettes
      • Paris, France, 75012
        • Groupe Hospitalier Diaconesses Croix Saint Simon
      • Saint-Herblain, France, 44805
        • Institut de Cancerologie de l'Ouest - site St-Herblain
      • Strasbourg, France, 67200
        • Institut de cancérologie Strasbourg Europe (ICANS)
      • Villejuif, France, 94800
        • Gustave Roussy
  • Germany
      • Berlin, Germany, 13353
        • Charite Universitaetsmedizin Berlin
      • Bonn, Germany, 53127
        • Universitaetsklinikum Bonn
      • Essen, Germany, 45136
        • KEM | Evang. Kliniken Essen-Mitte gGmbH
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg
      • Homburg, Germany, 66421
        • Universitaetsklinikum des Saarlandes
      • Kiel, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel
      • Mannheim, Germany, D-68167
        • Universitaetsmedizin Mannheim
      • Wiesbaden, Germany, 65199
        • Helios Dr. Horst Schmidt Kliniken Wiesbaden
  • Italy
      • Aviano, Italy, 33081
        • Centro Riferimento Oncologico - Aviano
      • Ponderano, Italy, 13875
        • Nuovo Ospedale Degli Infermi
      • Prato, Italy, 59100
        • Azienda USL Toscana Centro-Ospedale di Prato Santo Stefano
      • Rome, Italy, 168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
      • Torino, Italy, 10128
        • A.O. Ordine Mauriziano di Torino
      • Treviso, Italy, 31100
        • Azienda ULSS 2 Marca trevigiana-Ospedale Ca Foncello Treviso
  • Singapore
      • Singapore, Singapore, 119074
        • National University Cancer Institute
  • South Korea
      • Daegu, South Korea, 42601
        • Keimyung University Dongsan Hospital
      • Goyang-si, South Korea, 10408
        • National Cancer Center
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 5505
        • Asan Medical Center, University of Ulsan
      • Seoul, South Korea, 6273
        • Gangnam Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 6591
        • Seoul St. Mary's Hospital, The Catholic University of Korea
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
      • Barcelona, Spain, 8908
        • Institut Català d'Oncologia - L'Hospitalet
      • Girona, Spain, 17007
        • Institut Catala de Oncologia - Girona
      • Las Palmas de Gran Canaria, Spain, 35016
        • Hospital Universitario Insular de Gran Canaria
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal
      • Murcia, Spain, 30120
        • Hospital Clínico Universitario Virgen de la Arrixaca
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Vigo, Spain, 36312
        • Hospital Alvaro Cunqueiro
  • Taiwan
      • Chang-hua, Taiwan, 500
        • Changhua Christian Hospital (CCH)
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Tainan City, Taiwan, 704
        • National Cheng Kung University Hospital
      • Tainan City, Taiwan, 704
        • Linkou Chang Gung Memorial Hospital (CGMHLK)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University - Addenbrooke's Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom, NW1 2PG
        • University College London Hospital
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • University of Alabama at Birmingham
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Women's Cancer Care
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology
    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego (UCSD)- Moores Cancer Center
      • Los Angeles, California, United States, 90025
        • University of California, Los Angeles (UCLA)
      • Oxnard, California, United States, 93030
        • Ventura County Hematology- Oncology
    • Florida
      • Orlando, Florida, United States, 32808
        • University of Florida (UF) Health Cancer Center - Orlando Health
      • Sarasota, Florida, United States, 34240
        • Sarasota Memorial Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University (IU)
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
    • Michigan
      • Detroit, Michigan, United States, 48224
        • Barbara Ann Karmanos Cancer Institute
      • Ypsilanti, Michigan, United States, 48197
        • Trinity Health Ann Arbor Hospital
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Astera Cancer Care
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • New York
      • Albany, New York, United States, 12208
        • Womens Cancer Care Associates
      • Hawthorne, New York, United States, 105832
        • Westchester Medical Center
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10065
        • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Vidant Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati (UC) - Cancer Institute
      • Columbus, Ohio, United States, 43219
        • Mid Ohio Oncology/Hematology, Inc. dba The Mark H. Zangmeister Center
      • Columbus, Ohio, United States, 43026
        • The Ohio State University (OSU)
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Williamette Valley Cancer Institute and Research Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19014
        • University of Pennsylvania
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology - Austin Central (Balcones Dr.)
      • Bedford, Texas, United States, 76022
        • Texas Oncology - DFWW (Bedford)
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology - Fort Worth Cancer Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia - Emily Couric Cancer Center
      • Gainesville, Virginia, United States, 20155
        • Virginia Cancer Specialists, PC (Lake Manassas Dr)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient is female and ≥18 years of age.
  • Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous, endometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal cancer.
  • Patient has platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically on or after their most recent line of anticancer therapy.
  • Patient must have received at least 1 prior line of systemic anticancer therapy in the platinum sensitive setting, and no more than 5 prior lines of systemic anticancer therapy in the platinum-resistant setting. Patient must have received at least 1 line of therapy containing bevacizumab.
  • Patient has at least one measurable lesion that qualifies as a target lesion based on RECISTv1.1.
  • Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifying archival tumor tissue.

Exclusion Criteria:

  • Patient has primary platinum-refractory disease or primary platinum resistance, defined as disease progression during first-line platinum-based therapy (refractory) or disease progression <3 months after completion of first-line platinum-based therapy (resistant).
  • Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcoma subtype.
  • Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumor with low malignant potential (ie, borderline or low-grade serous tumor).
  • Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis) of ≥500 mL within 4 weeks of first dose of study drug.
  • Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof.
  • Patient has prior exposure to any anti-PD1/PD-L1 therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nemvaleukin and Pembrolizumab Combination
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
Other Names:
  • Keytruda
  • Nemvaleukin alfa
  • ALKS 4230
Active Comparator: Investigator's Choice
Options for protocol-specific Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator will pre-select the Investigator's choice treatment before the randomization of each patient.
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+)
Other Names:
  • Myocet
  • DOXIL
  • PLD- CAELYX
  • LIPODOX
Drug: Paclitaxel
80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min
Other Names:
  • Taxol
  • Nov-Onxol
  • Onxol
  • Paclitaxel Novaplus
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
Other Names:
  • Hycamtin
  • Potactasol
Drug: Gemcitabine
1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min
Other Names:
  • Gemzar
  • Infugem
Experimental: Pembrolizumab (enrollment completed)
Biological: Pembrolizumab
Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
Other Names:
  • Keytruda
Experimental: Nemvaleukin (enrollment completed)
Biological: Nemvaleukin
Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes
Other Names:
  • Nemvaleukin alfa
  • ALKS 4230

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From the first dose of study drug up to 24 months
Estimates based on Kaplan-Meier method.
From the first dose of study drug up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) as Assessed by Investigator
Time Frame: From the first dose of study drug up to 20 months
Response is based on RECIST v1.1 criteria.
From the first dose of study drug up to 20 months
Disease Control Rate (DCR) as Assessed by Investigator
Time Frame: From the first dose of study drug up to 20 months
Response is based on RECIST v1.1 criteria.
From the first dose of study drug up to 20 months
Duration of Response (DOR) as Assessed by Investigator
Time Frame: From the first dose of study drug up to 20 months
Response is based on RECIST v1.1 criteria.
From the first dose of study drug up to 20 months
Time to Response (TTR) as Assessed by Investigator
Time Frame: From the first dose of study drug up to 20 months
Response is based on RECIST v1.1 criteria.
From the first dose of study drug up to 20 months
Percentage of Participants With Cancer Antigen (CA)-125 Response as Defined by the Gynecologic Cancer Inter Group (GCIG)
Time Frame: From the first dose of study drug up to 20 months
A Cancer Antigen-125 response is defined as at least a 50% reduction in CA-125 levels from baseline, and the response must be confirmed and maintained for at least 28 days as per the GCIG.
From the first dose of study drug up to 20 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From first dose of study drug up to 90 days after last dose (up to 23 months)
From first dose of study drug up to 90 days after last dose (up to 23 months)
Progression-free Survival (PFS) as Assessed by Investigator
Time Frame: From the first dose of study drug up to 20 months
From the first dose of study drug up to 20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mural Oncology, Inc

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Mural Oncology Medical Monitor, Mural Oncology, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Actual)

January 8, 2025

Study Completion (Actual)

May 8, 2025

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALKS 4230-007
  • GOG-3063 (Other Identifier: The GOG Foundation)
  • ENGOT-OV68 (Other Identifier: European Network Gynaecological Oncological Trial groups)
  • KEYNOTE-C71 (Other Identifier: Merck)
  • APGOT-OV8 (Other Identifier: APAC Gynecologic Oncology Trial Group)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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