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

PHASE3TerminatedINTERVENTIONAL
Enrollment

456

Participants

Timeline

Start Date

January 10, 2022

Primary Completion Date

January 8, 2025

Study Completion Date

May 8, 2025

Conditions
Platinum-resistant Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer
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

Trial Locations (117)

168

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

500

Changhua Christian Hospital (CCH), Chang-hua

704

Linkou Chang Gung Memorial Hospital (CGMHLK), Tainan City

National Cheng Kung University Hospital, Tainan City

1000

Chu Saint-Pierre, Brussels

1090

Medizinische Universitaet Wien, Vienna

1130

Wiener Gesundheitsverbund - Klinik Hietzing, Vienna

1200

Cliniques Universitaires Saint-Luc, Brussels

2148

Blacktown Hospital, Blacktown

2500

Wollongong Hospital (Illawarra Shoalhaven Local Health District), Wollongong

2605

Canberra Hospital, Garran

2930

AZ Klina, Brasschaat

3184

Epworth HealthCare, East Melbourne

4000

Clinique CHC MontLégia, Liège

4029

Royal Brisbane and Women's Hospital, Brisbane

4066

Icon Cancer Centre, South Brisbane

5000

Cancer Research SA, Adelaide

5505

Asan Medical Center, University of Ulsan, Seoul

6020

Medizinische Universitaet Innsbruck, Innsbruck

6273

Gangnam Severance Hospital, Yonsei University Health System, Seoul

6591

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

6800

LKH Feldkirch, Feldkirch

8036

Medizinische Universitaet Graz, Graz

8400

AZ Damiaan, Ostend

8800

AZ Delta, Roeselare

8908

Institut Catala d'Oncologia - L'Hospitalet, Barcelona

10002

National Taiwan University Hospital, Taipei

10016

NYU Langone Health, New York

10065

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

10128

A.O. Ordine Mauriziano di Torino, Torino

10408

National Cancer Center, Goyang-si

11217

Taipei Veterans General Hospital, Taipei

12208

Womens Cancer Care Associates, Albany

12808

Vseobecna fakultni nemocnice v Praze, Prague

13009

Institut Paoli-Calmettes, Marseille

13353

Charite Universitaetsmedizin Berlin, Berlin

13875

Nuovo Ospedale degli Infermi, Ponderano

17007

Institut Catala de Oncologia - Girona, Girona

19014

University of Pennsylvania, Philadelphia

20155

Virginia Cancer Specialists, PC (Lake Manassas Dr), Gainesville

21201

University of Maryland School of Medicine, Baltimore

22908

University of Virginia - Emily Couric Cancer Center, Charlottesville

24105

Universitaetsklinikum Schleswig-Holstein Campus Kiel, Kiel

27834

Vidant Medical Center, Greenville

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28050

Centro Integral Oncologico Clara Campal, Madrid

30120

Hospital Clinico Universitario Virgen de la Arrixaca, Murcia

30322

Emory University, Atlanta

31100

Azienda ULSS 2 Marca trevigiana-Ospedale Ca Foncello Treviso, Treviso

32808

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

33081

Centro Riferimento Oncologico - Aviano, Aviano

34240

Sarasota Memorial Hospital, Sarasota

35016

Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria

35216

University of Alabama at Birmingham, Birmingham

36312

Hospital Alvaro Cunqueiro, Vigo

40705

Taichung Veterans General Hospital, Taichung

42601

Keimyung University Dongsan Hospital, Daegu

43026

The Ohio State University (OSU), Columbus

43219

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

44805

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

45219

University of Cincinnati (UC) - Cancer Institute, Cincinnati

46010

Hospital Clinico Universitario de Valencia, Valencia

46202

Indiana University (IU), Indianapolis

48197

Trinity Health Ann Arbor Hospital, Ypsilanti

48224

Barbara Ann Karmanos Cancer Institute, Detroit

49055

Institut de Cancerologie de l'Ouest - site Angers, Angers

53127

Universitaetsklinikum Bonn, Bonn

57105

Avera Cancer Institute, Sioux Falls

59100

Azienda USL Toscana Centro-Ospedale di Prato Santo Stefano, Prato

60611

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

65199

Helios Dr. Horst Schmidt Kliniken Wiesbaden, Wiesbaden

65653

Masarykuv onkologicky ustav, Brno

66421

Universitaetsklinikum des Saarlandes, Homburg

67200

Institut de cancerologie Strasbourg Europe (ICANS), Strasbourg

69008

Centre Leon Berard, Lyon

69120

Universitaetsklinikum Heidelberg, Heidelberg

70809

Mary Bird Perkins Cancer Center, Baton Rouge

75012

Groupe Hospitalier Diaconesses Croix Saint Simon, Paris

76022

Texas Oncology - DFWW (Bedford), Bedford

76104

Texas Oncology - Fort Worth Cancer Center, Fort Worth

77030

Baylor College of Medicine, Houston

78731

Texas Oncology - Austin Central (Balcones Dr.), Austin

85711

Arizona Oncology, Tucson

87131

University of New Mexico, Albuquerque

90025

University of California, Los Angeles (UCLA), Los Angeles

92093

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

93030

Ventura County Hematology- Oncology, Oxnard

94800

Gustave Roussy, Villejuif

97213

Providence Portland Medical Center, Portland

97401

Williamette Valley Cancer Institute and Research Center, Eugene

99508

Alaska Women's Cancer Care, Anchorage

105832

Westchester Medical Center, Hawthorne

119074

National University Cancer Institute, Singapore

08816

Astera Cancer Care, East Brunswick

08901

Rutgers Cancer Institute of New Jersey, New Brunswick

T2N 4N2

Tom Baker Cancer Centre, Calgary

L8V 5C2

Juravinski Cancer Centre, Hamilton

N6A 5W9

London Health Sciences Centre, London

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2M9

Princess Margaret Hospital, Toronto

J1H 5N4

Centre Hospitalier Universite de Sherbrooke (CHUS), Sherbrooke

181 00

Fakultni nemocnice Bulovka, Prague

Unknown

"KEM , Evang. Kliniken Essen-Mitte gGmbH"

D-68167

Universitaetsmedizin Mannheim, Mannheim

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

08036

Hospital Clinic Barcelona, Barcelona

CB2 0QQ

Cambridge University - Addenbrooke's Hospital, Cambridge

NW1 2PG

University College London Hospital, London

SE1 9RT

Guy's and St Thomas' NHS Foundation Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

OX3 9DU

Oxford University Hospitals NHS Foundation Trust, Oxford

Sponsors
All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Mural Oncology, Inc

INDUSTRY

NCT05092360 - Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) | Biotech Hunter | Biotech Hunter