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

The purpose of this study is to find how effective the investigative drug, nemvaleukin, is alone and in combination with pembrolizumab in treating epithelial ovarian, fallopian tube, or primary peritoneal cancer compared with chemotherapy.

The medications used in this study will be administered via an intravenous (IV, meaning through your veins) infusion. The study drug (nemvaleukin) being used is “investigational,” which means that it is not approved by the U.S. Food and Drug Administration (FDA) and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied.

This study has 4 different treatment arms as a potential treatment for your advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer that has become resistant to platinum-based therapy. 

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
  • gemcitabine

Participation may last up to 3 years.

In order to participate you must meet the following criteria:

• Are female and ≥18 years of age.
• Have been diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
• Have 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). 
• 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.
• Are willing to undergo a pre-treatment tumor biopsy or provide qualifying archival tumor tissue.

You will be excluded from the study if any of the following criteria apply to you:

• Have primary platinum-refractory disease or primary platinum resistance.
• Have confirmed diagnosis of epithelial ovarian cancer with mucinous or carcinosarcoma subtype.
• Have received prior IL-2-based or IL-15-based cytokine therapy, or has prior exposure to any anti-PD1/PD-L1 therapy.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.