Montag, 6. Mai 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
ARTISTRY-7

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

Rekrutierend

NCT-Nummer:
NCT05092360

Studienbeginn:
Januar 2022

Letztes Update:
23.04.2024

Wirkstoff:
Nemvaleukin and Pembrolizumab Combination, Pembrolizumab, Nemvaleukin, Pegylated Liposomal Doxorubicin (PLD), Paclitaxel, Topotecan, Gemcitabine

Indikation (Clinical Trials):
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Mural Oncology, Inc

Collaborator:
Merck Sharp & Dohme LLC

Studienleiter

Mural Oncology Medical Monitor
Study Director
Mural Oncology, Inc

Kontakt

Senior Direct, Global Clinical Services
Kontakt:
Phone: 781-614-0100 (US Only)
E-Mail: clinicaltrials@muraloncology.com» Kontaktdaten anzeigen

Studienlocations
(3 von 132)

Charite Universitaetsmedizin Berlin
13353 Berlin
(Berlin)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsklinikum Bonn
53127 Bonn
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
KEM | Evang. Kliniken Essen-Mitte gGmbH
45136 Essen
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsklinikum des Saarlandes
66421 Homburg
(Saarland)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsklinikum Schleswig-Holstein Campus Kiel
24105 Kiel
(Schleswig-Holstein)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsmedizin Mannheim
D-68167 Mannheim
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Helios Dr. Horst Schmidt Kliniken Wiesbaden
65199 Wiesbaden
(Hessen)
GermanyAktiv, nicht rekrutierend» Google-Maps
University of Alabama at Birmingham
35216 Birmingham
United StatesRekrutierend» Google-Maps
Alaska Women's Cancer Care
99508 Anchorage
United StatesRekrutierend» Google-Maps
University of California, San Diego (UCSD)- Moores Cancer Center
92093 La Jolla
United StatesRekrutierend» Google-Maps
University of California, Los Angeles (UCLA)
90025 Los Angeles
United StatesRekrutierend» Google-Maps
Ventura County Hematology- Oncology
93030 Oxnard
United StatesRekrutierend» Google-Maps
University of Florida (UF) Health Cancer Center - Orlando Health
32808 Orlando
United StatesRekrutierend» Google-Maps
Sarasota Memorial Hospital
34240 Sarasota
United StatesRekrutierend» Google-Maps
Northwestern University
60611 Chicago
United StatesRekrutierend» Google-Maps
Rush University Medical Center
60612 Chicago
United StatesRekrutierend» Google-Maps
Indiana University (IU)
46202 Indianapolis
United StatesRekrutierend» Google-Maps
Norton Cancer Institute
40207 Louisville
United StatesZurückgezogen» Google-Maps
Mary Bird Perkins Cancer Center
70809 Baton Rouge
United StatesRekrutierend» Google-Maps
University of Maryland School of Medicine
21201 Baltimore
United StatesRekrutierend» Google-Maps
Barbara Ann Karmanos Cancer Institute
48224 Detroit
United StatesRekrutierend» Google-Maps
Trinity Health Ann Arbor Hospital
48197 Ypsilanti
United StatesRekrutierend» Google-Maps
Astera Cancer Care
08816 East Brunswick
United StatesRekrutierend» Google-Maps
Rutgers Cancer Institute of New Jersey
08901 New Brunswick
United StatesRekrutierend» Google-Maps
University of New Mexico
87131 Albuquerque
United StatesRekrutierend» Google-Maps
Womens Cancer Care Associates
12208 Albany
United StatesRekrutierend» Google-Maps
Westchester Medical Center
105832 Hawthorne
United StatesRekrutierend» Google-Maps
Columbia University
10032 New York
United StatesZurückgezogen» Google-Maps
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
Vidant Medical Center
27834 Greenville
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Cincinnati (UC) - Cancer Institute
45219 Cincinnati
United StatesRekrutierend» Google-Maps
The Ohio State University (OSU)
43026 Columbus
United StatesRekrutierend» Google-Maps
Columbus Community Clinical Oncology Program
43215 Columbus
United StatesZurückgezogen» Google-Maps
Mid Ohio Oncology/Hematology, Inc. dba The Mark H. Zangmeister Center
43219 Columbus
United StatesRekrutierend» Google-Maps
Williamette Valley Cancer Institute and Research Center
97401 Eugene
United StatesRekrutierend» Google-Maps
Providence Portland Medical Center
97213 Portland
United StatesRekrutierend» Google-Maps
University of Pennsylvania
19014 Philadelphia
United StatesRekrutierend» Google-Maps
Greenville Health System
29615 Greenville
United StatesZurückgezogen» Google-Maps
Avera Cancer Institute
57105 Sioux Falls
United StatesRekrutierend» Google-Maps
Texas Oncology - Austin Central (Balcones Dr.)
78731 Austin
United StatesRekrutierend» Google-Maps
Texas Oncology - DFWW (Bedford)
76022 Bedford
United StatesRekrutierend» Google-Maps
Texas Oncology - Fort Worth Cancer Center
76104 Fort Worth
United StatesRekrutierend» Google-Maps
Baylor College of Medicine
77030 Houston
United StatesRekrutierend» Google-Maps
University of Virginia - Emily Couric Cancer Center
22908 Charlottesville
United StatesRekrutierend» Google-Maps
Virginia Cancer Specialists, PC (Lake Manassas Dr)
20155 Gainesville
United StatesRekrutierend» Google-Maps
Cancer Research SA
5000 Adelaide
AustraliaAktiv, nicht rekrutierend» Google-Maps
Blacktown Hospital
2148 Blacktown
AustraliaAktiv, nicht rekrutierend» Google-Maps
Royal Brisbane and Women's Hospital
4029 Brisbane
AustraliaAktiv, nicht rekrutierend» Google-Maps
Epworth HealthCare
3184 East Melbourne
AustraliaAktiv, nicht rekrutierend» Google-Maps
Canberra Hospital
2605 Garran
AustraliaAktiv, nicht rekrutierend» Google-Maps
Shoalhaven Cancer Care Centre
2540 Nowra
AustraliaAktiv, nicht rekrutierend» Google-Maps
Prince of Wales Hospital
2031 Randwick
AustraliaAktiv, nicht rekrutierend» Google-Maps
Icon Cancer Centre
4066 South Brisbane
AustraliaAktiv, nicht rekrutierend» Google-Maps
Wollongong Hospital (Illawarra Shoalhaven Local Health District)
2500 Wollongong
AustraliaAktiv, nicht rekrutierend» Google-Maps
Medizinische Universitaet Graz
8036 Graz
AustriaAktiv, nicht rekrutierend» Google-Maps
Medizinische Universitaet Innsbruck
6020 Innsbruck
AustriaAktiv, nicht rekrutierend» Google-Maps
Medizinische Universitaet Wien
1090 Vienna
AustriaAktiv, nicht rekrutierend» Google-Maps
Wiener Gesundheitsverbund - Klinik Hietzing
1130 Vienna
AustriaAktiv, nicht rekrutierend» Google-Maps
Chu Saint-Pierre
1000 Brussels
BelgiumAktiv, nicht rekrutierend» Google-Maps
Cliniques Universitaires Saint-Luc
1200 Brussel
BelgiumAktiv, nicht rekrutierend» Google-Maps
Clinique CHC MontLégia
4000 Liège
BelgiumAktiv, nicht rekrutierend» Google-Maps
Tom Baker Cancer Centre
T2N 4N2 Calgary
CanadaAktiv, nicht rekrutierend» Google-Maps
Juravinski Cancer Centre
L8V 5C2 Hamilton
CanadaAktiv, nicht rekrutierend» Google-Maps
London Health Sciences Centre
N6A 5W9 London
CanadaAktiv, nicht rekrutierend» Google-Maps
Sunnybrook Health Sciences Centre
M4N 3M5 Toronto
CanadaAktiv, nicht rekrutierend» Google-Maps
Princess Margaret Hospital
M5G 2M9 Toronto
CanadaAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier Universite de Sherbrooke (CHUS)
J1H 5N4 Sherbrooke
CanadaAktiv, nicht rekrutierend» Google-Maps
Masarykuv onkologicky ustav
65653 Brno
CzechiaAktiv, nicht rekrutierend» Google-Maps
Vseobecna fakultni nemocnice v Praze
12808 Prague
CzechiaAktiv, nicht rekrutierend» Google-Maps
Fakultni nemocnice Bulovka
181 00 Prague
CzechiaAktiv, nicht rekrutierend» Google-Maps
Institut de Cancerologie de l'Ouest - site Angers
49055 Angers
FranceAktiv, nicht rekrutierend» Google-Maps
Institut Paoli-Calmettes
13009 Marseille
FranceAktiv, nicht rekrutierend» Google-Maps
Groupe Hospitalier Diaconesses Croix Saint Simon
75012 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
Institut de Cancerologie de l'Ouest - site St-Herblain
44805 Saint-Herblain
FranceAktiv, nicht rekrutierend» Google-Maps
Institut de cancerologie Strasbourg Europe (ICANS)
67200 Strasbourg
FranceAktiv, nicht rekrutierend» Google-Maps
Gustave Roussy
94800 Villejuif
FranceAktiv, nicht rekrutierend» Google-Maps
Hillel Yaffe Medical Center
38100 Hadera
IsraelAktiv, nicht rekrutierend» Google-Maps
Hadassah Medical Center Ein Karem
9112001 Jerusalem
IsraelAktiv, nicht rekrutierend» Google-Maps
Kaplan Medical Center
7610001 Reẖovot
IsraelAktiv, nicht rekrutierend» Google-Maps
Centro Riferimento Oncologico - Aviano
33081 Aviano
ItalyAktiv, nicht rekrutierend» Google-Maps
Nuovo Ospedale degli Infermi
13875 Ponderano
ItalyAktiv, nicht rekrutierend» Google-Maps
Azienda USL Toscana Centro-Ospedale di Prato Santo Stefano
59100 Prato
ItalyAktiv, nicht rekrutierend» Google-Maps
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
168 Rome
ItalyAktiv, nicht rekrutierend» Google-Maps
A.O. Ordine Mauriziano di Torino
10128 Torino
ItalyAktiv, nicht rekrutierend» Google-Maps
Azienda ULSS 2 Marca trevigiana-Ospedale Ca Foncello Treviso
31100 Treviso
ItalyAktiv, nicht rekrutierend» Google-Maps
Keimyung University Dongsan Hospital
42601 Daegu
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Asan Medical Center, University of Ulsan
5505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Gangnam Severance Hospital, Yonsei University Health System
6273 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Seoul St. Mary's Hospital, The Catholic University of Korea
6591 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
National University Cancer Institute
119074 Singapore
SingaporeAktiv, nicht rekrutierend» Google-Maps
Curie Oncology
329563 Singapore
SingaporeAktiv, nicht rekrutierend» Google-Maps
Institut Catala d'Oncologia - L'Hospitalet
8908 Barcelona
SpainRekrutierend» Google-Maps
Institut Catala de Oncologia - Girona
17007 Girona
SpainRekrutierend» Google-Maps
Hospital Universitario Insular de Gran Canaria
35016 Las Palmas De Gran Canaria
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Centro Integral Oncologico Clara Campal
28050 Madrid
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario Virgen de la Arrixaca
30120 Murcia
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia
46010 Valencia
SpainRekrutierend» Google-Maps
Changhua Christian Hospital (CCH)
500 Chang Hua
TaiwanAktiv, nicht rekrutierend» Google-Maps
China Medical University Hospital
40447 Taichung
TaiwanAktiv, nicht rekrutierend» Google-Maps
Taichung Veterans General Hospital
40705 Taichung
TaiwanAktiv, nicht rekrutierend» Google-Maps
Linkou Chang Gung Memorial Hospital (CGMHLK)
704 Tainan
TaiwanAktiv, nicht rekrutierend» Google-Maps
National Cheng Kung University Hospital
704 Tainan
TaiwanAktiv, nicht rekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
Taipei Veterans General Hospital
11217 Taipei
TaiwanAktiv, nicht rekrutierend» Google-Maps
Cambridge University - Addenbrooke's Hospital
CB2 0QQ Cambridge
United KingdomAktiv, nicht rekrutierend» Google-Maps
University College London Hospital
NW1 2PG London
United KingdomAktiv, nicht rekrutierend» Google-Maps
Guy's and St Thomas' NHS Foundation Trust
SE1 9RT London
United KingdomAktiv, nicht rekrutierend» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomAktiv, nicht rekrutierend» Google-Maps
Oxford University Hospitals NHS Foundation Trust
OX3 9DU Oxford
United KingdomAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Overall Survival (OS) (Time Frame - Up to 3 years)



Secondary outcome:

1. Objective response rate as assessed by Investigator (Time Frame - Up to 1 year)

2. Disease Control Rate (DCR) as assessed by Investigator (Time Frame - Up to 1 year)

3. Duration of Response (DOR) as assessed by Investigator (Time Frame - Up to 1 year)

4. Time to Response (TTR) as assessed by Investigator (Time Frame - Up to 18-24 weeks)

5. Cancer antigen (CA)-125 response as defined by the Gynecologic Cancer InterGroup (GCIG) (Time Frame - Up to 1 year)

6. Incidence of treatment-emergent adverse events (TEAEs) (Time Frame - Up to 3 years)

7. Progression-free survival (PFS) as assessed by Investigator (Time Frame - Up to 1 year)

Studien-Arme

  • Experimental: Nemvaleukin and Pembrolizumab Combination
  • Experimental: Pembrolizumab (enrollment completed)
  • Experimental: Nemvaleukin (enrollment completed)
  • Active Comparator: Investigator's Choice
    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.

Geprüfte Regime

  • Nemvaleukin and Pembrolizumab Combination (Nemvaleukin alfa / ALKS 4230 / Keytruda / ):
    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 (Keytruda):
    Pembrolizumab: 200 mg; Day 1 of 21-day cycles; IV infusion over 30 minutes
  • Nemvaleukin (Nemvaleukin alfa / ALKS 4230 / ):
    Nemvaleukin: 6 µg/kg/day; Days 1 through 5 of 21-day cycles; IV infusion over 30 minutes
  • Pegylated Liposomal Doxorubicin (PLD) (PLD- CAELYX / DOXIL / LIPODOX / Myocet / ):
    40 mg/m2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+)
  • Paclitaxel (Nov-Onxol / Taxol / Onxol / Paclitaxel Novaplus / ):
    80 mg/m2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min
  • Topotecan (Hycamtin / Potactasol / ):
    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 (Gemzar / Infugem / ):
    1,000 mg/m2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

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

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.