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 6 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 20 Locations for this study
Tucson Arizona, 85711, United States
Ventura California, 93030, United States
Orlando Florida, 32808, United States
Sarasota Florida, 34240, United States
New Brunswick New Jersey, 08901, United States
Albany New York, 12208, United States
Valhalla New York, 10901, United States
Greenville North Carolina, 27834, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43215, United States
McMinnville Oregon, 97128, United States
Portland Oregon, 97213, United States
Greenville South Carolina, 29605, United States
Sioux Falls South Dakota, 57105, United States
Austin Texas, 78731, United States
Fort Worth Texas, 76104, United States
Gainesville Virginia, 20155, United States
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 5, Canada
Sherbrooke Quebec, J1H 5, Canada
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