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Platinum-resistant Ovarian CancerPhase 3ARTISTRY-7NCT05092360

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

A Phase 3 study testing Nemvaleukin and Pembrolizumab Combination, Pembrolizumab and Nemvaleukin in people with Platinum-resistant Ovarian Cancer and Fallopian Tube Cancer, run by Mural Oncology, Inc at 117 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Nemvaleukin and Pembrolizumab Combination, Pembrolizumab and Nemvaleukin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
456 participants
Where
117 sitesin 14 countries
Study dates
10 Jan 2022to 8 May 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

117 sites in 14 countries.

117 sites in 14 countries

United States37 sites

  • Womens Cancer Care Associates

    Albany, New York, 12208

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Emory University

    Atlanta, Georgia, 30322

  • Texas Oncology - Austin Central (Balcones Dr.)

    Austin, Texas, 78731

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Texas Oncology - DFWW (Bedford)

    Bedford, Texas, 76022

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35216

  • University of Virginia - Emily Couric Cancer Center

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati (UC) - Cancer Institute

    Cincinnati, Ohio, 45219

  • The Ohio State University (OSU)

    Columbus, Ohio, 43026

  • Mid Ohio Oncology/Hematology, Inc. dba The Mark H. Zangmeister Center

    Columbus, Ohio, 43219

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48224

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Williamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Virginia Cancer Specialists, PC (Lake Manassas Dr)

    Gainesville, Virginia, 20155

  • Vidant Medical Center

    Greenville, North Carolina, 27834

  • Westchester Medical Center

    Hawthorne, New York, 105832

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University (IU)

    Indianapolis, Indiana, 46202

  • University of California, San Diego (UCSD)- Moores Cancer Center

    La Jolla, California, 92093

  • University of California, Los Angeles (UCLA)

    Los Angeles, California, 90025

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • NYU Langone Health

    New York, New York, 10016

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Florida (UF) Health Cancer Center - Orlando Health

    Orlando, Florida, 32808

  • Ventura County Hematology- Oncology

    Oxnard, California, 93030

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19014

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34240

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Arizona Oncology

    Tucson, Arizona, 85711

  • Trinity Health Ann Arbor Hospital

    Ypsilanti, Michigan, 48197

Other trials in United States

Spain12 sites

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Institut Catala d'Oncologia - L'Hospitalet

    Barcelona, 8908

  • Institut Catala de Oncologia - Girona

    Girona, 17007

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Clinico Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Alvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

Germany8 sites

  • Charite Universitaetsmedizin Berlin

    Berlin, 13353

  • Universitaetsklinikum Bonn

    Bonn, 53127

  • KEM | Evang. Kliniken Essen-Mitte gGmbH

    Essen, 45136

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum des Saarlandes

    Homburg, 66421

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105

  • Universitaetsmedizin Mannheim

    Mannheim, D-68167

  • Helios Dr. Horst Schmidt Kliniken Wiesbaden

    Wiesbaden, 65199

Other trials in Germany

South Korea8 sites

  • Keimyung University Dongsan Hospital

    Daegu, 42601

  • National Cancer Center

    Goyang-si, 10408

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

  • Asan Medical Center, University of Ulsan

    Seoul, 5505

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 6273

  • Seoul St. Mary's Hospital, The Catholic University of Korea

    Seoul, 6591

Other trials in South Korea

Australia7 sites

  • Cancer Research SA

    Adelaide, 5000

  • Blacktown Hospital

    Blacktown, 2148

  • Royal Brisbane and Women's Hospital

    Brisbane, 4029

  • Epworth HealthCare

    East Melbourne, 3184

  • Canberra Hospital

    Garran, 2605

  • Icon Cancer Centre

    South Brisbane, 4066

  • Wollongong Hospital (Illawarra Shoalhaven Local Health District)

    Wollongong, 2500

Other trials in Australia

France7 sites

  • Institut de Cancerologie de l'Ouest - site Angers

    Angers, 49055

  • Centre Leon Berard

    Lyon, 69008

  • Institut Paoli-Calmettes

    Marseille, 13009

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris, 75012

  • Institut de Cancerologie de l'Ouest - site St-Herblain

    Saint-Herblain, 44805

  • Institut de cancerologie Strasbourg Europe (ICANS)

    Strasbourg, 67200

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

Belgium6 sites

  • AZ Klina

    Brasschaat, 2930

  • Chu Saint-Pierre

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Clinique CHC MontLégia

    Liège, 4000

  • AZ Damiaan

    Ostend, 8400

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Canada6 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Centre Hospitalier Universite de Sherbrooke (CHUS)

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Italy6 sites

  • Centro Riferimento Oncologico - Aviano

    Aviano, 33081

  • Nuovo Ospedale degli Infermi

    Ponderano, 13875

  • Azienda USL Toscana Centro-Ospedale di Prato Santo Stefano

    Prato, 59100

  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Rome, 168

  • A.O. Ordine Mauriziano di Torino

    Torino, 10128

  • Azienda ULSS 2 Marca trevigiana-Ospedale Ca Foncello Treviso

    Treviso, 31100

Other trials in Italy

Taiwan6 sites

  • Changhua Christian Hospital (CCH)

    Chang-hua, 500

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Linkou Chang Gung Memorial Hospital (CGMHLK)

    Tainan, 704

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Austria5 sites

  • LKH Feldkirch

    Feldkirch, 6800

  • Medizinische Universitaet Graz

    Graz, 8036

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020

  • Medizinische Universitaet Wien

    Vienna, 1090

  • Wiener Gesundheitsverbund - Klinik Hietzing

    Vienna, 1130

Other trials in Austria

United Kingdom5 sites

  • Cambridge University - Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • University College London Hospital

    London, NW1 2PG

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU

Other trials in United Kingdom

Czechia3 sites

  • Masarykuv onkologicky ustav

    Brno, 65653

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

  • Fakultni nemocnice Bulovka

    Prague, 181 00

Other trials in Czechia

Singapore1 site

  • National University Cancer Institute

    Singapore, 119074

Other trials in Singapore

About this study

Official title: 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.

Read the 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.

Being tested
Nemvaleukin and Pembrolizumab Combination, Pembrolizumab, Nemvaleukin, Pegylated Liposomal Doxorubicin (PLD), Paclitaxel
Keywords
PROC, EOC, ALKS 4230, IL-2, Ovarian Cancer, KEYNOTE-C71, Platinum Resistant, Epithelian Ovarian Cancer, Nemvaleukin alfa, Pembrolizumab, ARTISTRY-7, ART-7, paclitaxel, pegylated liposoma doxorubicin, PLD, topotecan, gemzar, gemcitabine
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nemvaleukin and Pembrolizumab CombinationBiological

    Also called Nemvaleukin alfa, ALKS 4230, Keytruda

    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

  • PembrolizumabBiological

    Also called Keytruda

    Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes

  • NemvaleukinBiological

    Also called Nemvaleukin alfa, ALKS 4230

    Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes

  • Pegylated Liposomal Doxorubicin (PLD)Drug

    Also called PLD- CAELYX, DOXIL, LIPODOX, Myocet

    40 mg/m2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+)

  • PaclitaxelDrug

    Also called Nov-Onxol, Taxol, Onxol, Paclitaxel Novaplus

    80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min

  • TopotecanDrug

    Also called Hycamtin, Potactasol

    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

  • GemcitabineDrug

    Also called Gemzar, Infugem

    1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min

Study groups in NCT05092360
Study groupRoleWhat they receive
Nemvaleukin and Pembrolizumab CombinationExperimentalNot described
Receives: Biological: Nemvaleukin and Pembrolizumab Combination
Pembrolizumab (enrollment completed)ExperimentalNot described
Receives: Biological: Pembrolizumab
Nemvaleukin (enrollment completed)ExperimentalNot described
Receives: Biological: Nemvaleukin
Investigator's ChoiceActive comparatorOptions 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.
Receives: Drug: Pegylated Liposomal Doxorubicin (PLD); Drug: Paclitaxel; Drug: Topotecan; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Estimates based on Kaplan-Meier method.

    Measured: From the first dose of study drug up to 24 months

Secondary outcomes (7)

  1. Objective Response Rate (ORR) as Assessed by Investigator

    Response is based on RECIST v1.1 criteria.

    Measured: From the first dose of study drug up to 20 months

  2. Disease Control Rate (DCR) as Assessed by Investigator

    Response is based on RECIST v1.1 criteria.

    Measured: From the first dose of study drug up to 20 months

  3. Duration of Response (DOR) as Assessed by Investigator

    Response is based on RECIST v1.1 criteria.

    Measured: From the first dose of study drug up to 20 months

  4. Time to Response (TTR) as Assessed by Investigator

    Response is based on RECIST v1.1 criteria.

    Measured: From the first dose of study drug up to 20 months

  5. Percentage of Participants With Cancer Antigen (CA)-125 Response as Defined by the Gynecologic Cancer Inter Group (GCIG)

    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.

    Measured: From the first dose of study drug up to 20 months

  6. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Measured: From first dose of study drug up to 90 days after last dose (up to 23 months)

  7. Progression-free Survival (PFS) as Assessed by Investigator

    Measured: From the first dose of study drug up to 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start10 Jan 2022
  3. Primary completion8 Jan 2025
  4. Study completion8 May 2025

Why it stopped: Study terminated due to business and strategic decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
456 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05092360
Sponsor's protocol ID
ALKS 4230-007
Other IDs
GOG-3063, ENGOT-OV68, KEYNOTE-C71, APGOT-OV8
Acronym
ARTISTRY-7
Status last verified
Jun 2025
First submitted
13 Oct 2021
Last updated
28 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Herzog TJ, Hays JL, Barlin JN, Buscema J, Cloven NG, Kong LR, Tyagi NK, Lanneau GS, Long BJ, Marsh RL, Seward SM, Starks DC, Welch S, Moore KN, Konstantinopoulos PA, Gilbert L, Monk BJ, O'Malley DM, Chen X, Dalal R, Coleman RL, Sehouli J. ARTISTRY-7: phase III trial of nemvaleukin alfa plus pembrolizumab vs chemotherapy for platinum-resistant ovarian cancer. Future Oncol. 2023 Jul;19(23):1577-1591. doi: 10.2217/fon-2023-0246. Epub 2023 Jun 19.

    PubMed 37334673

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nemvaleukin and Pembrolizumab Combination, Pembrolizumab and Nemvaleukin in people with Platinum-resistant Ovarian Cancer and Fallopian Tube Cancer, run by Mural Oncology, Inc at 117 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Spain, Germany, South Korea, Australia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From the first dose of study drug up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05092360, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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