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

Alkermes Inc.0 个研究点目标入组 13 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

阶段: 3 期
状态: 撤回
发起方: Alkermes Inc.
入组人数: 13

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

年龄范围: 18 至 99（—）

入选标准

•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 (i.e., 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.
•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.
•b. Note: Patients who have platinum-refractory or platinum-resistant disease to
•frontline treatment are excluded.
•6. Patient must have received at least 1 prior line of systemic anticancer
•therapy in the platinum sensitive setting, and no more than 5 prior lines of
•systemic anticancer therapy in the platinum-resistant setting. Patient must
•have received at least 1 line of therapy containing bevacizumab.
•The following guidelines apply:
•a. 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.
•b. Adjuvant ± neoadjuvant is considered 1 line of therapy.
•c. Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered
•part of the preceding line of therapy (i.e., not counted independently).
•d. Therapy that changed due to toxicity in the absence of progression will be
•considered part of the same line (ie, not counted independently).
•e. Hormonal therapy will be counted as a separate line of therapy unless it was
•given as maintenance therapy.
•f. Patients having received only 1 line of 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.
•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 lesion.
•8. Patient is willing to undergo a pre-treatment tumor biopsy or provide
•qualifying archival tumor tissue. All pretreatment tissue must have been
•collected no more than 120 days prior to screening. Central testing of PD-L1
•status will be required prior to randomization.
•9. Patient has recovered from the effects of any previous chemotherapy,
•immunotherapy, other prior systemic anticancer therapy, radiotherapy, and/or
•surgery (i.e., residual toxicity no worse than Grade 1 [Grade 2
•treatment-associated peripheral neuropathy and/or any grade of alopecia are
另有 1 项未显示

排除标准

•1. Patient has primary platinum-refractory disease or primary platinum
•resistance, defined as disease progression during first-line platinumbased
•therapy (refractory) or disease progression <3 months after completion of
•first-line platinum-based therapy (resistant).
•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 lowgrade serous
•4. Patient requires fluid drainage (eg, paracentesis, thoracentesis,
•pericardiocentesis) of >=500 ml within 6 weeks of 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.
•8. Patient has taken non-steroid 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
•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
•intra-ocular 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 or laboratory
•findings that may interfere with the planned treatment, affect patient
•compliance, such as recent serious trauma, or mental illness or substance use,
•which may interfere with the a

研究者

发起方

Alkermes Inc.

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