phase 3 study of nemvaleukin alfa in combination with pembrolizumab in patients with platinum-resistant epithelial ovarian cancer (artistry-7)

Conditions: Platinum-resistant Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

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.

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 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.

Keywords: proc eoc alks 4230 il-2 ovarian cancer keynote-c71 platinum resistant epithelian ovarian cancer nemvaleukin alfa pembrolizumab artistry-7 art-7 paclitaxel pegylated liposoma doxorubicin pld topotecan gemzar gemcitabine