EUCTR2021-005099-21-NO进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Upifitamab Rilsodotin (XMT-1536) as Post-Platinum Maintenance Therapy for Participants with Recurrent, Platinum-Sensitive Ovarian Cancer (UP-NEXT)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 581
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.Participants must be at least 18 years of age, and female.
- •2.Participant must have an ECOG performance status 0 or 1
- •3.Participant must have a histological diagnosis of high grade serous ovarian cancer, which includes fallopian tube and primary peritoneal cancer, that is metastatic or recurrent.
- •4.Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
- •5.Participant must have platinum-sensitive recurrent disease, defined as having achieved either a partial or complete response to 4 or more cycles in their penultimate platinum- containing regimen and their disease progressing more than 6 months after completion of the last dose of platinum containing therapy in the penultimate regimen.
- •6.Participant must have had 4 to 8 cycles of platinum-based chemotherapy in 2nd to 4th line setting in their most recent treatment regimen as defined below:
- •a. Platinum-based chemotherapy regimens allowed immediately preceding enrollment to the study: carboplatin or cisplatin ±: paclitaxel, docetaxel, pegylated liposomal doxorubicin or gemcitabine.
- •b. Participant must receive first study treatment infusion between 4 and 12 weeks after completing final dose of platinum in the most recent platinum-based regimen.
- •c. Definitions for prior lines of therapy:
- •-Adjuvant ± neoadjuvant considered one line of therapy as long as they are the same regimens (e.g., platinum/taxane for 4 cycles before surgery followed by platinum/taxane for 4 cycles after surgery)
- •-Maintenance therapy (e.g., bevacizumab, PARPi, endocrine therapy) will be considered as part of the preceding line of therapy (i.e., not counted independently)
- •- Therapy given for only 1 cycle and discontinued due to toxicity in the absence of progression will not be counted as a new line of therapy; therapy given for 2 or more cycles will be counted as a line of therapy. Substitutions of different platinum agents or taxanes will not be counted as new lines.
- •-Hormonal therapy (e.g., tamoxifen, letrozole) will be counted as a separate line of therapy unless given as maintenance.
- •d. In Italy and Norway, participants must have exhausted or be ineligible for the treatment options approved for maintenance treatment of recurrent, platinum sensitive HGSOC.
- •7. Participant must have had as their best response to last line of treatment one of the following: No Evidence of Disease (NED); Complete Response (CR); Partial Response (PR); OR Stable Disease (SD)
- •8. Participants with NED, CR, or PR as their best response to most recent line of treatment and who have not received treatment with a prior PARP inhibitor must have definitive BRCA1 and BRCA2 testing results that demonstrate no evidence of a deleterious BRCA1 or BRCA2 mutation. Somatic BRCA mutation testing is required for participants who are classified as not having a deleterious mutation by germline testing alone.
- •9. Participant must provide either a tumor tissue block or fresh cut slides for measurement of NaPi2b expression by a central laboratory. If sufficient archival tumor tissue is not available, then a tumor tissue block or slides must be obtained from a fresh biopsy and provided to the central laboratory. Confirmation of a NaPi2b-H/positive tumor by the central laboratory is required prior to randomization.
- •10. Participants with toxicity from prior therapy or surgical procedures must have recovered to Grade =1. Participants with alopecia, stable immune
排除标准
- •1. Participant has received prior treatment with mirvetuximab soravtansine or another ADC containing an auristatin or maytansinoid payload.
- •2. Participant has received bevacizumab in combination with last platinum-based regiment or plans to receive maintenance therapy outside the study intervention.
- •3. Participant has clinical signs or symptoms of gastrointestinal obstruction and/or requirement for parenteral hydration or nutrition.
- •4. Participant has ascites or pleural effusion managed with therapeutic paracentesis or thoracentesis within 28 days prior to signing the principal study consent form.
- •5. Participant has history of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver disease. Testing beyond laboratory studies otherwise defined in the eligibility criteria, to diagnose potentially clinically significant liver disease based on risk factors such as hepatic steatosis or history of excessive alcohol intake, will be based on clinical judgement of the investigator.
- •6. Participants cannot receive drugs associated with hepatotoxicity concurrent with upifitamab rilsodotin administration except as outlined in Appendix 4.
- •7. Participant currently uses either constant or intermittent supplementary oxygen therapy.
- •8. Participant has history of or suspected pneumonitis or interstitial lung disease.
- •9. Participant has oxygen saturation on room air <93%.
- •10. Participant has had major surgery or systemic anti-cancer therapy within 28 days of starting study treatment.
- •11. Participant has a low-grade, clear cell, endometrioid, mucinous, carcinosarcoma, germ- cell, mixed histology, or stromal tumor.
- •12. Participant has untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis, or carcinomatous meningitis.
- •- Participants are eligible if CNS metastases are adequately treated and are neurologically stable for at least 2 weeks prior to enrollment.
- •- In addition, participants must be either off corticosteroids, or on a stable/decreasing dose of = 10 mg daily prednisone (or equivalent). Anticonvulsants are allowed except for those drugs associated with liver toxicity.
- •13. Participant has untreated, known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). In addition, negative serology is required during screening (baseline) for HBV and HCV:
- •- HBV: Participants with serologic evidence of chronic HBV infection should have an HBV viral load below the limit of quantification to be eligible.
- •- HCV: Participants with a history of HCV infection should have completed curative antiviral treatment and HCV viral load below the limit of quantification.
- •- Screening for HIV is not required except if mandated by local regulations or indicated based on clinical assessment.
- •14. Participant has current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could interfere with per-protocol evaluations. Further, participants are excluded with the following characteristics:
- •- A marked baseline prolongation of QTcF interval CTCAE Grade >1: repeated demonstration of a QTcF interval >480 milliseconds (ms) using Fridericia's QT correction formula.
- •- A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- •15. Has a diagnosis of additional malignancy that required treatm
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