Ovarian Cancer Clinical Trial

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

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.

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Full 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 Arm 3: Nemvaleukin monotherapy Arm 4: Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.

View Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

376

Study ID:

NCT05092360

Recruitment Status:

Recruiting

Sponsor:

Alkermes, Inc.

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There are 91 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

376

Study ID:

NCT05092360

Recruitment Status:

Recruiting

Sponsor:


Alkermes, Inc.

How clear is this clinincal trial information?

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