Ovarian Cancer Clinical Trial

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

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.

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Full 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 (enrollment completed) Arm 3: Nemvaleukin monotherapy (enrollment completed) Arm 4: Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

448

Study ID:

NCT05092360

Recruitment Status:

Recruiting

Sponsor:

Mural Oncology, Inc

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There are 131 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35216, United States
Alaska Women's Cancer Care
Anchorage Alaska, 99508, United States
Arizona Oncology
Tucson Arizona, 85711, United States
University of California, San Diego (UCSD)- Moores Cancer Center
La Jolla California, 92093, United States
University of California, Los Angeles (UCLA)
Los Angeles California, 90025, United States
Ventura County Hematology- Oncology
Oxnard California, 93030, United States
University of Florida (UF) Health Cancer Center - Orlando Health
Orlando Florida, 32808, United States
Sarasota Memorial Hospital
Sarasota Florida, 34240, United States
Emory University
Atlanta Georgia, 30322, United States
Northwestern University
Chicago Illinois, 60611, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Indiana University (IU)
Indianapolis Indiana, 46202, United States
Norton Cancer Institute
Louisville Kentucky, 40207, United States
Mary Bird Perkins Cancer Center
Baton Rouge Louisiana, 70809, United States
University of Maryland School of Medicine
Baltimore Maryland, 21201, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48224, United States
Trinity Health Ann Arbor Hospital
Ypsilanti Michigan, 48197, United States
Astera Cancer Care
East Brunswick New Jersey, 08816, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
University of New Mexico
Albuquerque New Mexico, 87131, United States
Womens Cancer Care Associates
Albany New York, 12208, United States
Westchester Medical Center
Hawthorne New York, 10583, United States
NYU Langone Health
New York New York, 10016, United States
Columbia University
New York New York, 10032, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Vidant Medical Center
Greenville North Carolina, 27834, United States
University of Cincinnati (UC) - Cancer Institute
Cincinnati Ohio, 45219, United States
The Ohio State University (OSU)
Columbus Ohio, 43026, United States
Columbus Community Clinical Oncology Program
Columbus Ohio, 43215, United States
Mid Ohio Oncology/Hematology, Inc. dba The Mark H. Zangmeister Center
Columbus Ohio, 43219, United States
Williamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19014, United States
Greenville Health System
Greenville South Carolina, 29615, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Texas Oncology - Austin Central (Balcones Dr.)
Austin Texas, 78731, United States
Texas Oncology - DFWW (Bedford)
Bedford Texas, 76022, United States
Texas Oncology - Fort Worth Cancer Center
Fort Worth Texas, 76104, United States
Baylor College of Medicine
Houston Texas, 77030, United States
University of Virginia - Emily Couric Cancer Center
Charlottesville Virginia, 22908, United States
Virginia Cancer Specialists, PC (Lake Manassas Dr)
Gainesville Virginia, 20155, United States
Cancer Research SA
Adelaide , 5000, Australia
Blacktown Hospital
Blacktown , 2148, Australia
Royal Brisbane and Women's Hospital
Brisbane , 4029, Australia
Epworth HealthCare
East Melbourne , 3184, Australia
Canberra Hospital
Garran , 2605, Australia
Shoalhaven Cancer Care Centre
Nowra , 2540, Australia
Prince of Wales Hospital
Randwick , 2031, Australia
Icon Cancer Centre
South Brisbane , 4066, Australia
Wollongong Hospital (Illawarra Shoalhaven Local Health District)
Wollongong , 2500, Australia
LKH Feldkirch
Feldkirch , 6800, Austria
Medizinische Universitaet Graz
Graz , 8036, Austria
Medizinische Universitaet Innsbruck
Innsbruck , 6020, Austria
Medizinische Universitaet Wien
Vienna , 1090, Austria
Wiener Gesundheitsverbund - Klinik Hietzing
Vienna , 1130, Austria
AZ Klina
Brasschaat , 2930, Belgium
Chu Saint-Pierre
Brussels , 1000, Belgium
Cliniques Universitaires Saint-Luc
Brussel , 1200, Belgium
Clinique CHC MontLégia
Liège , 4000, Belgium
AZ Damiaan
Oostende , 8400, Belgium
AZ Delta
Roeselare , 8800, Belgium
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
London Health Sciences Centre
London Ontario, N6A 5, Canada
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada
Centre Hospitalier Universite de Sherbrooke (CHUS)
Sherbrooke Quebec, J1H 5, Canada
Masarykuv onkologicky ustav
Brno , 65653, Czechia
Vseobecna fakultni nemocnice v Praze
Prague , 12808, Czechia
Fakultni nemocnice Bulovka
Prague , 181 0, Czechia
Institut de Cancerologie de l'Ouest - site Angers
Angers , 49055, France
Centre Leon Berard
Lyon , 69008, France
Institut Paoli-Calmettes
Marseille , 13009, France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris , 75012, France
Institut de Cancerologie de l'Ouest - site St-Herblain
Saint-Herblain , 44805, France
Institut de cancerologie Strasbourg Europe (ICANS)
Strasbourg , 67200, France
Gustave Roussy
Villejuif , 94800, France
Charite Universitaetsmedizin Berlin
Berlin , 13353, Germany
Universitaetsklinikum Bonn
Bonn , 53127, Germany
KEM | Evang. Kliniken Essen-Mitte gGmbH
Essen , 45136, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitaetsklinikum des Saarlandes
Homburg , 66421, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel , 24105, Germany
Universitaetsmedizin Mannheim
Mannheim , D-681, Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden , 65199, Germany
Hillel Yaffe Medical Center
Hadera , 38100, Israel
Rambam Health Care Campus
Haifa , 31096, Israel
Carmel Medical Center
Haifa , 34362, Israel
Wolfson Medical Center
H̱olon , 58220, Israel
Hadassah Medical Center Ein Karem
Jerusalem , 91120, Israel
Sheba Medical Center
Ramat Gan , 52656, Israel
Kaplan Medical Center
Reẖovot , 76100, Israel
Centro Riferimento Oncologico - Aviano
Aviano , 33081, Italy
Nuovo Ospedale degli Infermi
Ponderano , 13875, Italy
Azienda USL Toscana Centro-Ospedale di Prato Santo Stefano
Prato , 59100, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome , 168, Italy
A.O. Ordine Mauriziano di Torino
Torino , 10128, Italy
Azienda ULSS 2 Marca trevigiana-Ospedale Ca Foncello Treviso
Treviso , 31100, Italy
Keimyung University Dongsan Hospital
Daegu , 42601, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Asan Medical Center, University of Ulsan
Seoul , 5505, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
Seoul , 6273, Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul , 6591, Korea, Republic of
National University Cancer Institute
Singapore , 11907, Singapore
Curie Oncology
Singapore , 32956, Singapore
Hospital Clinic Barcelona
Barcelona , 08036, Spain
Institut Catala d'Oncologia - L'Hospitalet
Barcelona , 8908, Spain
Institut Catala de Oncologia - Girona
Girona , 17007, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas De Gran Canaria , 35016, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Clinico San Carlos
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Centro Integral Oncologico Clara Campal
Madrid , 28050, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia , 30120, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Hospital Alvaro Cunqueiro
Vigo , 36312, Spain
Changhua Christian Hospital (CCH)
Chang Hua , 500, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
Linkou Chang Gung Memorial Hospital (CGMHLK)
Tainan , 704, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Cambridge University - Addenbrooke's Hospital
Cambridge , CB2 0, United Kingdom
University College London Hospital
London , NW1 2, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London , SE1 9, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford , OX3 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

448

Study ID:

NCT05092360

Recruitment Status:

Recruiting

Sponsor:


Mural Oncology, Inc

How clear is this clinincal trial information?

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