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.
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Clinical Trial Information
Trial Contact: Durand, Jennifer; Ribacchi, Stephanie; Casillas, Bridey L
Trial Phone: 321.843.2026 ; 321-841-1077 ; 321.841.8284
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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, KEYNOTE-C71
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
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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
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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.
