Clinical trial NCT05092360: Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
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
Lead sponsor: Mural Oncology, Inc
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-10-25
Enrollment: 456
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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