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

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 peritonealcancer.

• Patient has platinum-resistant/refractory disease, defined as disease progressionwithin 180 days following the last administered dose of platinum therapy beyondfirst-line setting (resistant) or lack of response or disease progression whilereceiving the most recent platinum-based therapy (refractory). Patient must haveprogressed radiographically on or after their most recent line of anticancertherapy.

• Patient must have received at least 1 prior line of systemic anticancer therapy inthe platinum sensitive setting, and no more than 5 prior lines of systemicanticancer therapy in the platinum-resistant setting. Patient must have received atleast 1 line of therapy containing bevacizumab.

• Patient has at least one measurable lesion that qualifies as a target lesion basedon RECISTv1.1.

• Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifyingarchival 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-basedtherapy (resistant).

• Patient has histologically confirmed diagnosis of EOC with mucinous orcarcinosarcoma subtype.

• Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovariantumor 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 hashad exposure, including intralesional, to IL-12 or analogs thereof.

• Patient has prior exposure to any anti-PD1/PD-L1 therapy.