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

Fallopian Tube Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092360
• Other study ID #: ALKS 4230-007
• Secondary ID: GOG-3063ENGOT-OV
• Status: Recruiting
• Phase: Phase 3
• Start date: January 10, 2022
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Mural Oncology, Inc
• Contact: Senior Direct, Global Clinical Services
• Phone: 781-614-0100 (US Only)
• Email: clinicaltrials[@]muraloncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 448
• Est. completion date: May 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Platinum-resistant Ovarian Cancer
• Primary Peritoneal Cancer

Intervention

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
• Pembrolizumab
Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
• 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+)
• Paclitaxel
80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min
• 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
• Gemcitabine
1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min

Locations

Country	Name	City	State
Australia	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	Shoalhaven Cancer Care Centre	Nowra
Australia	Prince of Wales Hospital	Randwick
Australia	Icon Cancer Centre	South Brisbane
Australia	Wollongong Hospital (Illawarra Shoalhaven Local Health District)	Wollongong
Austria	LKH Feldkirch	Feldkirch
Austria	Medizinische Universitaet Graz	Graz
Austria	Medizinische Universitaet Innsbruck	Innsbruck
Austria	Medizinische Universitaet Wien	Vienna
Austria	Wiener Gesundheitsverbund - Klinik Hietzing	Vienna
Belgium	AZ Klina	Brasschaat
Belgium	Cliniques Universitaires Saint-Luc	Brussel
Belgium	Chu Saint-Pierre	Brussels
Belgium	Clinique CHC MontLégia	Liège
Belgium	AZ Damiaan	Oostende
Belgium	AZ Delta	Roeselare
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Centre Hospitalier Universite de Sherbrooke (CHUS)	Sherbrooke	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Czechia	Masarykuv onkologicky ustav	Brno
Czechia	Fakultni nemocnice Bulovka	Prague
Czechia	Vseobecna fakultni nemocnice v Praze	Prague
France	Institut de Cancerologie de l'Ouest - site Angers	Angers
France	Centre Leon Berard	Lyon
France	Institut Paoli-Calmettes	Marseille
France	Groupe Hospitalier Diaconesses Croix Saint Simon	Paris
France	Institut de Cancerologie de l'Ouest - site St-Herblain	Saint-Herblain
France	Institut de cancerologie Strasbourg Europe (ICANS)	Strasbourg
France	Gustave Roussy	Villejuif
Germany	Charite Universitaetsmedizin Berlin	Berlin
Germany	Universitaetsklinikum Bonn	Bonn
Germany	KEM | Evang. Kliniken Essen-Mitte gGmbH	Essen
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Universitaetsklinikum des Saarlandes	Homburg
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel	Kiel
Germany	Universitaetsmedizin Mannheim	Mannheim
Germany	Helios Dr. Horst Schmidt Kliniken Wiesbaden	Wiesbaden
Israel	Wolfson Medical Center	H_olon
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Carmel Medical Center	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah Medical Center Ein Karem	Jerusalem
Israel	Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Re?ovot
Italy	Centro Riferimento Oncologico - Aviano	Aviano
Italy	Nuovo Ospedale degli Infermi	Ponderano
Italy	Azienda USL Toscana Centro-Ospedale di Prato Santo Stefano	Prato
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore	Rome
Italy	A.O. Ordine Mauriziano di Torino	Torino
Italy	Azienda ULSS 2 Marca trevigiana-Ospedale Ca Foncello Treviso	Treviso
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Asan Medical Center, University of Ulsan	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Singapore	Curie Oncology	Singapore
Singapore	National University Cancer Institute	Singapore
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Institut Catala d'Oncologia - L'Hospitalet	Barcelona
Spain	Institut Catala de Oncologia - Girona	Girona
Spain	Hospital Universitario Insular de Gran Canaria	Las Palmas De Gran Canaria
Spain	Centro Integral Oncologico Clara Campal	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Clinico Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital Alvaro Cunqueiro	Vigo
Taiwan	Changhua Christian Hospital (CCH)	Chang Hua
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Linkou Chang Gung Memorial Hospital (CGMHLK)	Tainan
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	Cambridge University - Addenbrooke's Hospital	Cambridge
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	University College London Hospital	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United States	Womens Cancer Care Associates	Albany	New York
United States	University of New Mexico	Albuquerque	New Mexico
United States	Alaska Women's Cancer Care	Anchorage	Alaska
United States	Emory University	Atlanta	Georgia
United States	Texas Oncology - Austin Central (Balcones Dr.)	Austin	Texas
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Texas Oncology - DFWW (Bedford)	Bedford	Texas
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Virginia - Emily Couric Cancer Center	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati (UC) - Cancer Institute	Cincinnati	Ohio
United States	Columbus Community Clinical Oncology Program	Columbus	Ohio
United States	Mid Ohio Oncology/Hematology, Inc. dba The Mark H. Zangmeister Center	Columbus	Ohio
United States	The Ohio State University (OSU)	Columbus	Ohio
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Astera Cancer Care	East Brunswick	New Jersey
United States	Williamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Texas Oncology - Fort Worth Cancer Center	Fort Worth	Texas
United States	Virginia Cancer Specialists, PC (Lake Manassas Dr)	Gainesville	Virginia
United States	Greenville Health System	Greenville	South Carolina
United States	Vidant Medical Center	Greenville	North Carolina
United States	Westchester Medical Center	Hawthorne	New York
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University (IU)	Indianapolis	Indiana
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	Norton Cancer Institute	Louisville	Kentucky
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Columbia University	New York	New York
United States	David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center	New York	New York
United States	NYU Langone Health	New York	New York
United States	University of Florida (UF) Health Cancer Center - Orlando Health	Orlando	Florida
United States	Ventura County Hematology- Oncology	Oxnard	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Providence Portland Medical Center	Portland	Oregon
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Arizona Oncology	Tucson	Arizona
United States	Trinity Health Ann Arbor Hospital	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Mural Oncology, Inc	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  Singapore,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)		Up to 3 years
Secondary	Objective response rate as assessed by Investigator		Up to 1 year
Secondary	Disease Control Rate (DCR) as assessed by Investigator		Up to 1 year
Secondary	Duration of Response (DOR) as assessed by Investigator		Up to 1 year
Secondary	Time to Response (TTR) as assessed by Investigator		Up to 18-24 weeks
Secondary	Cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG)		Up to 1 year
Secondary	Incidence of treatment-emergent adverse events (TEAEs)		Up to 3 years
Secondary	Progression-free survival (PFS) as assessed by Investigator		Up to 1 year