A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigators Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

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.