Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
18 Years and older, Female
ALKS 4230-007 (primary)
NCI-2022-04958
ENGOT-OV68
GOG-3063
KEYNOTE-C71
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.
Objectives
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.
Eligibility
- 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.
Treatment Sites in Georgia
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