Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
- Conditions
- Platinum-resistant Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancer
- Interventions
- Biological: PembrolizumabBiological: NemvaleukinBiological: Nemvaleukin and Pembrolizumab Combination
- Registration Number
- NCT05092360
- Lead Sponsor
- Mural Oncology, Inc
- 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.
- 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 (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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 456
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab (enrollment completed) Pembrolizumab - Nemvaleukin (enrollment completed) Nemvaleukin - Nemvaleukin and Pembrolizumab Combination Nemvaleukin and Pembrolizumab Combination - Investigator's Choice Pegylated Liposomal Doxorubicin (PLD) 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. Investigator's Choice Topotecan 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. Investigator's Choice Gemcitabine 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. Investigator's Choice Paclitaxel 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.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to 3 years
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) as assessed by Investigator Up to 1 year Progression-free survival (PFS) as assessed by Investigator Up to 1 year Disease Control Rate (DCR) as assessed by Investigator Up to 1 year Incidence of treatment-emergent adverse events (TEAEs) Up to 3 years Objective response rate as assessed by Investigator Up to 1 year Time to Response (TTR) as assessed by Investigator Up to 18-24 weeks Cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG) Up to 1 year
Trial Locations
- Locations (117)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Hospital Alvaro Cunqueiro
🇪🇸Vigo, Spain
Indiana University (IU)
🇺🇸Indianapolis, Indiana, United States
University of Cincinnati (UC) - Cancer Institute
🇺🇸Cincinnati, Ohio, United States
NYU Langone Health
🇺🇸New York, New York, United States
Alaska Women's Cancer Care
🇺🇸Anchorage, Alaska, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Cliniques Universitaires Saint-Luc
🇧🇪Brussel, Belgium
Chu Saint-Pierre
🇧🇪Brussels, Belgium
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Medizinische Universitaet Wien
🇦🇹Vienna, Austria
Arizona Oncology
🇺🇸Tucson, Arizona, United States
Centre Hospitalier Universite de Sherbrooke (CHUS)
🇨🇦Sherbrooke, Quebec, Canada
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Medizinische Universitaet Graz
🇦🇹Graz, Austria
Wiener Gesundheitsverbund - Klinik Hietzing
🇦🇹Vienna, Austria
LKH Feldkirch
🇦🇹Feldkirch, Austria
AZ Delta
🇧🇪Roeselare, Belgium
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
National University Cancer Institute
🇸🇬Singapore, Singapore
Changhua Christian Hospital (CCH)
🇨🇳Chang Hua, Taiwan
Linkou Chang Gung Memorial Hospital (CGMHLK)
🇨🇳Tainan, Taiwan
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Astera Cancer Care
🇺🇸East Brunswick, New Jersey, United States
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
A.O. Ordine Mauriziano di Torino
🇮🇹Torino, Italy
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California, San Diego (UCSD)- Moores Cancer Center
🇺🇸La Jolla, California, United States
University of California, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Ventura County Hematology- Oncology
🇺🇸Oxnard, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Trinity Health Ann Arbor Hospital
🇺🇸Ypsilanti, Michigan, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Westchester Medical Center
🇺🇸Hawthorne, New York, United States
Womens Cancer Care Associates
🇺🇸Albany, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
The Ohio State University (OSU)
🇺🇸Columbus, Ohio, United States
Vidant Medical Center
🇺🇸Greenville, North Carolina, United States
Williamette Valley Cancer Institute and Research Center
🇺🇸Eugene, Oregon, United States
Mid Ohio Oncology/Hematology, Inc. dba The Mark H. Zangmeister Center
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Texas Oncology - DFWW (Bedford)
🇺🇸Bedford, Texas, United States
University of Virginia - Emily Couric Cancer Center
🇺🇸Charlottesville, Virginia, United States
Texas Oncology - Fort Worth Cancer Center
🇺🇸Fort Worth, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Virginia Cancer Specialists, PC (Lake Manassas Dr)
🇺🇸Gainesville, Virginia, United States
Cancer Research SA
🇦🇺Adelaide, Australia
Blacktown Hospital
🇦🇺Blacktown, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Australia
Epworth HealthCare
🇦🇺East Melbourne, Australia
Canberra Hospital
🇦🇺Garran, Australia
Icon Cancer Centre
🇦🇺South Brisbane, Australia
Wollongong Hospital (Illawarra Shoalhaven Local Health District)
🇦🇺Wollongong, Australia
Medizinische Universitaet Innsbruck
🇦🇹Innsbruck, Austria
AZ Klina
🇧🇪Brasschaat, Belgium
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Clinique CHC MontLégia
🇧🇪Liège, Belgium
AZ Damiaan
🇧🇪Oostende, Belgium
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Masarykuv onkologicky ustav
🇨🇿Brno, Czechia
Institut de Cancerologie de l'Ouest - site Angers
🇫🇷Angers, France
Vseobecna fakultni nemocnice v Praze
🇨🇿Prague, Czechia
Fakultni nemocnice Bulovka
🇨🇿Prague, Czechia
Centre Leon Berard
🇫🇷Lyon, France
Institut Paoli-Calmettes
🇫🇷Marseille, France
Institut de cancerologie Strasbourg Europe (ICANS)
🇫🇷Strasbourg, France
Groupe Hospitalier Diaconesses Croix Saint Simon
🇫🇷Paris, France
Gustave Roussy
🇫🇷Villejuif, France
Charite Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Institut de Cancerologie de l'Ouest - site St-Herblain
🇫🇷Saint-Herblain, France
Universitaetsklinikum Bonn
🇩🇪Bonn, Germany
KEM | Evang. Kliniken Essen-Mitte gGmbH
🇩🇪Essen, Germany
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Helios Dr. Horst Schmidt Kliniken Wiesbaden
🇩🇪Wiesbaden, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Germany
Universitaetsmedizin Mannheim
🇩🇪Mannheim, Germany
Centro Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy
Azienda USL Toscana Centro-Ospedale di Prato Santo Stefano
🇮🇹Prato, Italy
Nuovo Ospedale degli Infermi
🇮🇹Ponderano, Italy
Azienda ULSS 2 Marca trevigiana-Ospedale Ca Foncello Treviso
🇮🇹Treviso, Italy
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center, University of Ulsan
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain
Institut Catala d'Oncologia - L'Hospitalet
🇪🇸Barcelona, Spain
Institut Catala de Oncologia - Girona
🇪🇸Girona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Insular de Gran Canaria
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Centro Integral Oncologico Clara Campal
🇪🇸Madrid, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
University College London Hospital
🇬🇧London, United Kingdom
Cambridge University - Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
Gangnam Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
University of Florida (UF) Health Cancer Center - Orlando Health
🇺🇸Orlando, Florida, United States
Texas Oncology - Austin Central (Balcones Dr.)
🇺🇸Austin, Texas, United States
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom