Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) (ARTISTRY-7)
L
Lisa Landrum, MD, PhD, MS
Primary Investigator
Overview
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.
Description
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 thewing: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
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Age: 18 Years
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Gender: Female
Inclusion Criteria:
- Patient is female and ≥18 years of age.
- Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous,dometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal.
- Patient has platinum-resistant/refractory disease, defined as disease progressionwithin 180 days following the last administered dose of platinum therapy beyondg (resistant) or lack of response or disease progression whileving the most recent platinum-based therapy (refractory). Patient must havegressed 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 theum sensitive setting, and no more than 5 prior lines of systemic anticancerherapy in the platinum-resistant setting. Patient must have received at least 1 lineherapy containing bevacizumab.
- Patient has at least one measurable lesion that qualifies as a target lesion based onRECISTv1.1.
- Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifyinghival 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)disease progression <3 months after completion of first-line platinum-based therapy(resistant).
- Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcomaubtype.
- Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumorwith low malignant potential (ie, borderline or low-grade serous tumor).
- Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis)≥500 mL within 6 weeks of first dose of study drug.
- Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has hadure, including intralesional, to IL-12 or analogs thereof.
- Patient has prior exposure to any anti-PD1/PD-L1 therapy.
Updated on
06 May 2024.
Study ID: ALKS 4230-007
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