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Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab (ARTISTRY-7)

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

  • Clinical Trial Information

    Trial Contact: Durand, Jennifer; Ribacchi, Stephanie

    Trial Phone: 321.843.2026 ; 321-841-1077

  • IRB No: 20215795

    Protocol Abbrev: GOG-3063

    Principal Investigator: Shelly Marie Seward, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: ALKS 4230-007

    Treatment: Biological: Nemvaleukin and Pembrolizumab Combination Biological: Pembrolizumab Biological: Nemvaleukin Drug: Pegylated Liposomal Doxorubicin (PLD) Drug: Paclitaxel Drug: Topotecan Drug: Gemcitabine

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT05092360

  • Objective

    To evaluate the antitumor activity of nemvaleukin alfa (‘nemvaleukin’, ALKS 4230) in combination with pembrolizumab as compared with chemotherapy in patients with platinum-resistant ovarian cancer

  • Key Eligibility

    1. Patient is female and ≥18 years of age.
    2. Patient or patient’s legal representative is willing and able to provide written informed
    consent.
    3. Patient is willing and able to comply with scheduled visits, treatment schedule, laboratory
    tests, and other requirements of the study.
    4. Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous, endometrioid of
    any grade, clear cell), fallopian tube cancer, or primary peritoneal cancer.
    5. 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.