Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)
Investigational Treatment Study for Platinum-Resistant Ovarian Cancer
Lisa Landrum, MD, PhD, MS
Primary Investigator
Brief description of study
Detailed description of study
- 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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
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Age: 18 years or above
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Gender: Female
- 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.
- 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.
This study investigates treatments for women with platinum-resistant epithelial ovarian cancer, which is a type of cancer that does not respond to platinum-based chemotherapy. The purpose is to compare the effects of different treatments, including an investigational medication called nemvaleukin, either alone or in combination with another treatment, pembrolizumab, against standard chemotherapy options.
Participants will be randomly assigned to one of four study arms: a combination of nemvaleukin and pembrolizumab, pembrolizumab alone, nemvaleukin alone, or a chemotherapy of the investigator's choice. Chemotherapy options may include pegylated liposomal doxorubicin, paclitaxel, topotecan, or gemcitabine. Each participant will undergo a pre-treatment tumor biopsy or provide existing tumor tissue for analysis.
- Who can participate: Women aged 18 and older with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible. Participants must have had at least one prior systemic anticancer therapy and a measurable lesion.
- Study details: Participants will be randomly assigned to one of four treatment arms, receiving either investigational medications or standard chemotherapy.
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