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 (ARTISTRY-7) - ARTISTRY-7

Mural Oncology, Inc.0 个研究点目标入组 450 人开始时间: 2022年9月5日最近更新: 2024年8月12日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Mural Oncology, Inc.
入组人数: 450

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: Female

入选标准

•1. Patient is female and =18 years of age.
•2. Patient or patient's legal representative (as applicable per regional requirements) has provided 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, fallopian tube cancer, or primary peritoneal cancer and histology subtype, high-grade serous, endometrioid of any grade, clear cell
•5. Patient has platinum-resistant/refractory disease: resistant is defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (ie, initial platinum therapy); and refractory is defined as disease progression or lack of response followed by disease progression while receiving the most recent platinum-based therapy (beyond initial therapy) or lack of response or disease progression while receiving the most recent platinum-based
•therapy (refractory). Patient must have progressed radiographically or by GCIG-defined CA-125 criteria on or after their most recent line of anticancer therapy beyond first-line setting.
•a. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic
•imaging showing progression or the date progression was assessed by GCIG-defined CA-125 criteria, whichever comes first.
•b. Note: Patients who have primary platinum-refractory or platinumresistant disease (disease progression <3 months after completion of first-line platinum based therapy) are excluded.
•6. Patient must have received at least 1 prior line of platinum-based therapy (as noted below), and no more than 5 prior lines of systemic anticancer therapy in the platinum-resistant disease (4 additional lines after
•the patient developed platinum-resistant/refractory disease). Patient must have received at least 1 line of therapy containing bevacizumab. The following guidelines apply:
•a. Patients who are primary platinum-resistant (developed resistance after initial platinum-based therapy) must have received at least 4 cycles of platinum, must have had a response (complete response [CR] or partial response [PR]) and then progressed =3 to =6 months after the date of the last dose of platinum
•b. Prior PARP inhibitor is allowed if included within these limits of prior therapy. Prior PARP inhibitor is required for patients with a breast cancer gene (BRCA) mutation.
•c. Adjuvant ± neoadjuvant is considered 1 line of therapy.
•d. Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered part of the preceding line of therapy (i.e., not counted independently).
•e. Therapy that changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently).
•f. Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance therapy.
•7. Patient has at least one measurable lesion that qualifies as a target lesion based on RECIST v1.1. Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are not considered measurable unless there has been demonstrated progression in the
•8. Patient is willing to provide a tumor tissue sample either collected from a prior biopsy or cytoreductive/debulking surgery occurring at any time since diagnosis or from a fresh biopsy (newly obtained tumor tissue) at Sc

排除标准

•1. Patient has primary platinum-refractory disease or primary platinum resistance: primary platinum-refractory disease is defined as disease progression during initial platinum based therapy; and primary platinum resistance is defined as disease progression < 3 months after completion of initial platinum-based therapy.
•2. Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcoma subtype.
•3. Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumor with low malignant potential (i.e., borderline or low grade serous tumor).
•4. Patient requires recurrent (=1 per month) fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis) or patient requires fluid drainage of =500 ml within 4 weeks of the expected date of the first dose of study drug.
•5. Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof.
•6. Patient has prior exposure to any antiPD1/PDL1 therapy.
•7. Patient requires or has taken systemic corticosteroids (>10 mg of prednisone daily, or equivalent)within 14 days prior to the first dose of study drug(s); however, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted. Note: patients requiring the use of a
•steroid during the Screening Period at a dose level of <10 mg of prednisone (or equivalent) per day are not excluded as long as the event
•requiring the use of the steroid has recovered to acceptable grade.
•8. Patient has taken nonsteroid systemic immunomodulatory agents (eg, etanercept, adalimumab, etc.) within 28 days prior to the first dose of study drug(s), or anticipates any use of these therapies during the study period.
•9. Patient has undergone any major surgical procedure within 3 weeks prior to Screening. Patients who have not recovered from any previous surgery that occurred more than 3 weeks prior to Screening are also excluded.
•10. Patient has undergone prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant.
•11. Patient has received a live or live-attenuated vaccine(s) within 30 days prior to the first dose of study drug(s). Note: Coronavirus Disease 2019 (COVID-19) vaccine is allowed; see guidance on COVID-19 vaccines in Section 7.3.2).
•12. Patient has had any active infection and/or a fever =38.5°C (= 101°F) within 3 days prior to the first dose of study drug(s) requiring systemic therapy. Antibiotics given for periprocedural prophylaxis or given presumptively for a limited time (eg, until infection was ruled out), as well as topical or intraocular antibiotics, shall not be exclusionary.
•13. Patient has active autoimmune disease(s) requiring systemic treatment within the past 2 years or a documented history of clinically severe autoimmune disease that has required chronic or frequent systemic steroids. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
•14. Patient has underlying chronic lung disease, chronic obstructive pulmonary disease, metastatic lung disease, pleural effusions, or other lung disorders (eg, pulmonary embolism) with a baseline room air oxygen saturation of <92% at screening and/or dyspnea (=Grade 3) which requires oxygen therapy.
•15. Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
•16. Patient has any other concurrent uncontrolled illness

研究者

发起方

Mural Oncology, Inc.

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