Ovarian Cancer Clinical Trial
Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
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.
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 Arm 3: Nemvaleukin monotherapy Arm 4: Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.
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.
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There are 91 Locations for this study
Birmingham Alabama, 35216, United States
Anchorage Alaska, 99508, United States
Tucson Arizona, 85711, United States
La Jolla California, 92093, United States
Oxnard California, 93030, United States
Orlando Florida, 32808, United States
Sarasota Florida, 34240, United States
Chicago Illinois, 60611, United States
Indianapolis Indiana, 46202, United States
Louisville Kentucky, 40207, United States
Baton Rouge Louisiana, 70809, United States
Baltimore Maryland, 21201, United States
Detroit Michigan, 48224, United States
Ypsilanti Michigan, 48197, United States
East Brunswick New Jersey, 08816, United States
New Brunswick New Jersey, 08901, United States
Albuquerque New Mexico, 87131, United States
Albany New York, 12208, United States
Hawthorne New York, 10583, United States
New York New York, 10032, United States
New York New York, 10065, United States
Greenville North Carolina, 27834, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43219, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19014, United States
Sioux Falls South Dakota, 57105, United States
Austin Texas, 78731, United States
Bedford Texas, 76022, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Charlottesville Virginia, 22908, United States
Gainesville Virginia, 20155, United States
Adelaide , 5000, Australia
East Melbourne , 3184, Australia
South Brisbane , 4066, Australia
Graz , 8036, Austria
Innsbruck , 6020, Austria
Vienna , 1090, Austria
Vienna , 1130, Austria
Brussels , 1000, Belgium
Calgary Alberta, T2N 4, Canada
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 5, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Sherbrooke Quebec, J1H 5, Canada
Prague , 181 0, Czechia
Marseille , 13009, France
Berlin , 13353, Germany
Bonn , 53127, Germany
Kiel , 24105, Germany
Wiesbaden , 65199, Germany
Haifa , 34362, Israel
Aviano , 33081, Italy
Ponderano , 13875, Italy
Prato , 59100, Italy
Rome , 168, Italy
Torino , 10128, Italy
Treviso , 31100, Italy
Daegu , 42601, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 5505, Korea, Republic of
Seoul , 6273, Korea, Republic of
Singapore , 32956, Singapore
Barcelona , 08036, Spain
Barcelona , 8908, Spain
Girona , 17007, Spain
Las Palmas De Gran Canaria , 35016, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Murcia , 30120, Spain
Valencia , 46010, Spain
Vigo , 36312, Spain
Chang Hua , 500, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Tainan , 704, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Cambridge , CB2 0, United Kingdom
London , NW1 2, United Kingdom
Oxford , OX3 9, United Kingdom
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