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

NCT05092360 | Terminated Phase 3 Results DMC FDA Drug

• 5 other identifiers: ALKS 4230-007GOG-3063ENGOT-OV68KEYNOTE-C71APGOT-OV8
• Study Type: interventional
• Target: 456
• Locations: 13 countries
• Sites: 110

Brief 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

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

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Estimates based on Kaplan-Meier method.

  From the first dose of study drug up to 24 months

Secondary Outcomes (7)

• Objective Response Rate (ORR) as Assessed by Investigator

  From the first dose of study drug up to 20 months

• Disease Control Rate (DCR) as Assessed by Investigator

  From the first dose of study drug up to 20 months

• Duration of Response (DOR) as Assessed by Investigator

  From the first dose of study drug up to 20 months

• Time to Response (TTR) as Assessed by Investigator

  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)

  From the first dose of study drug up to 20 months

Study Arms (4)

Nemvaleukin and Pembrolizumab Combination

EXPERIMENTAL

Biological: Nemvaleukin and Pembrolizumab Combination

Pembrolizumab (enrollment completed)

EXPERIMENTAL

Biological: Pembrolizumab

Nemvaleukin (enrollment completed)

EXPERIMENTAL

Biological: Nemvaleukin

Investigator's Choice

ACTIVE COMPARATOR

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); Drug: Paclitaxel; Drug: Topotecan; Drug: Gemcitabine

Interventions

Nemvaleukin and Pembrolizumab Combination BIOLOGICAL

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

Also known as: Nemvaleukin alfa, ALKS 4230, Keytruda

Nemvaleukin and Pembrolizumab Combination

Pembrolizumab BIOLOGICAL

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

Also known as: Keytruda

Pembrolizumab (enrollment completed)

Nemvaleukin BIOLOGICAL

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

Also known as: Nemvaleukin alfa, ALKS 4230

Nemvaleukin (enrollment completed)

Pegylated Liposomal Doxorubicin (PLD) DRUG

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

Also known as: PLD- CAELYX, DOXIL, LIPODOX, Myocet

Investigator's Choice

Paclitaxel DRUG

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

Also known as: Nov-Onxol, Taxol, Onxol, Paclitaxel Novaplus

Investigator's Choice

Topotecan DRUG

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

Also known as: Hycamtin, Potactasol

Investigator's Choice

Gemcitabine DRUG

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

Also known as: Gemzar, Infugem

Investigator's Choice

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mural Oncology, Inc: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (117)

University of Alabama at Birmingham

Birmingham, Alabama, 35216, United States

Location

Alaska Women's Cancer Care

Anchorage, Alaska, 99508, United States

Location

Arizona Oncology

Tucson, Arizona, 85711, United States

Location

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

La Jolla, California, 92093, United States

Location

University of California, Los Angeles (UCLA)

Los Angeles, California, 90025, United States

Location

Ventura County Hematology- Oncology

Oxnard, California, 93030, United States

Location

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

Orlando, Florida, 32808, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34240, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University (IU)

Indianapolis, Indiana, 46202, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48224, United States

Location

Trinity Health Ann Arbor Hospital

Ypsilanti, Michigan, 48197, United States

Location

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Womens Cancer Care Associates

Albany, New York, 12208, United States

Location

Westchester Medical Center

Hawthorne, New York, 105832, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

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

New York, New York, 10065, United States

Location

Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

University of Cincinnati (UC) - Cancer Institute

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University (OSU)

Columbus, Ohio, 43026, United States

Location

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

Columbus, Ohio, 43219, United States

Location

Williamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19014, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Texas Oncology - Austin Central (Balcones Dr.)

Austin, Texas, 78731, United States

Location

Texas Oncology - DFWW (Bedford)

Bedford, Texas, 76022, United States

Location

Texas Oncology - Fort Worth Cancer Center

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Virginia - Emily Couric Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Virginia Cancer Specialists, PC (Lake Manassas Dr)

Gainesville, Virginia, 20155, United States

Location

Cancer Research SA

Adelaide, 5000, Australia

Location

Blacktown Hospital

Blacktown, 2148, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, 4029, Australia

Location

Epworth HealthCare

East Melbourne, 3184, Australia

Location

Canberra Hospital

Garran, 2605, Australia

Location

Icon Cancer Centre

South Brisbane, 4066, Australia

Location

Wollongong Hospital (Illawarra Shoalhaven Local Health District)

Wollongong, 2500, Australia

Location

LKH Feldkirch

Feldkirch, 6800, Austria

Location

Medizinische Universitaet Graz

Graz, 8036, Austria

Location

Medizinische Universitaet Innsbruck

Innsbruck, 6020, Austria

Location

Medizinische Universitaet Wien

Vienna, 1090, Austria

Location

Wiener Gesundheitsverbund - Klinik Hietzing

Vienna, 1130, Austria

Location

AZ Klina

Brasschaat, 2930, Belgium

Location

Chu Saint-Pierre

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Clinique CHC MontLégia

Liège, 4000, Belgium

Location

AZ Damiaan

Ostend, 8400, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hospitalier Universite de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Masarykuv onkologicky ustav

Brno, 65653, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia

Location

Fakultni nemocnice Bulovka

Prague, 181 00, Czechia

Location

Institut de Cancerologie de l'Ouest - site Angers

Angers, 49055, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, 75012, France

Location

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

Saint-Herblain, 44805, France

Location

Institut de cancerologie Strasbourg Europe (ICANS)

Strasbourg, 67200, France

Location

Gustave Roussy

Villejuif, 94800, France

Location

Charite Universitaetsmedizin Berlin

Berlin, 13353, Germany

Location

Universitaetsklinikum Bonn

Bonn, 53127, Germany

Location

KEM | Evang. Kliniken Essen-Mitte gGmbH

Essen, 45136, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Universitaetsmedizin Mannheim

Mannheim, D-68167, Germany

Location

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, 65199, Germany

Location

Centro Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Nuovo Ospedale degli Infermi

Ponderano, 13875, Italy

Location

Azienda USL Toscana Centro-Ospedale di Prato Santo Stefano

Prato, 59100, Italy

Location

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

Rome, 168, Italy

Location

A.O. Ordine Mauriziano di Torino

Torino, 10128, Italy

Location

Azienda ULSS 2 Marca trevigiana-Ospedale Ca Foncello Treviso

Treviso, 31100, Italy

Location

National University Cancer Institute

Singapore, 119074, Singapore

Location

Keimyung University Dongsan Hospital

Daegu, 42601, South Korea

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Asan Medical Center, University of Ulsan

Seoul, 5505, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, 6273, South Korea

Location

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

Seoul, 6591, South Korea

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Institut Catala d'Oncologia - L'Hospitalet

Barcelona, 8908, Spain

Location

Institut Catala de Oncologia - Girona

Girona, 17007, Spain

Location

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, 35016, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

Location

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, 36312, Spain

Location

Changhua Christian Hospital (CCH)

Chang-hua, 500, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Linkou Chang Gung Memorial Hospital (CGMHLK)

Tainan, 704, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Cambridge University - Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

University College London Hospital

London, NW1 2PG, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37334673 DERIVED

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

pembrolizumab; liposomal doxorubicin; Doxorubicin; Paclitaxel; Taxes; Topotecan; Gemcitabine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Camptothecin; Alkaloids; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Study was terminated due to business and strategic decision.

Results Point of Contact

• Title: Study Director
• Organization: Mural Oncology, Inc.

clinicaltrials@muraloncology.com

+1 (781) 614-0100

Study Officials

• Mural Oncology Medical Monitor

  Mural Oncology, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 25, 2021
• Study Start: January 10, 2022
• Primary Completion: January 8, 2025
• Study Completion: May 8, 2025
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-06

Locations

ES (12); AU (5); BE (6); CZ (3); SG (1); TW (6); US (37); IT (6); GB (5); CA (6); FR (7); DE (8); KR (8)