A Phase II, Randomized, Open-label Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of M6620 in Combination with Avelumab and Carboplatin in Comparison toStandard of Care Therapy in Participants with PARPi-resistant Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer. - Phase II Study of Avelumab+M6620+Carboplatin in PARPi-resistant Ovaria

Merck KGaA0 个研究点目标入组 90 人开始时间: 2018年9月7日最近更新: 2020年6月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Merck KGaA
入组人数: 90

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 clinical trial of medicinal product

入排标准

性别: Female

入选标准

•1. Female participants with recurrent epithelial ovarian cancer who have disease progression following maintenance treatment with a PARPi as defined below:
•1.1 Participant must have histologically diagnosed epithelial ovarian, primary peritoneal, or fallopian tube cancer, with nonmucinous histology
•1.2 Participants must have completed at least 2 previous courses of platinum containing therapy (eg, carboplatin or cisplatin) and had documented response (complete response [CR] or partial response [PR]) to the last platinum-based treatment prior to treatment with a PARPi
•1.3 Participant has received the last dose of platinum-containing treatment at least 6 months prior to study enrollment
•1.4 Participant has documented disease progression (radiological) after at least 6 months of maintenance treatment with PARPi following a response to platinum-based chemotherapy.
•2. Confirmed BRCA 1/2 mutation status or agree to its testing on samples collected in the study.
•3. Available formalin-fixed, paraffin-embedded (FFPE) tumor biopsies.
•3.1 Part A: Participant should be willing to undergo 2 paired on-treatment biopsies on Day 2 of Cycle 1 or Cycle 2, before and after M6620 administration, if assessed as feasible at low risk by the interventional radiologist.
•3.2 Part B: Histological tissue specimen (tissue block or 8 to 10 unstained slides) must be available. An archival tumor biopsy is acceptable if obtained after the last progression on PARPi treatment and is less than 6 months old. Otherwise, participants must be willing to undergo mandatory biopsy during the Screening Period to obtain sufficient tissue for histological assessment. Participants need to have an attempted biopsy. However, participants who have measurable disease documented by a radiologist as not feasible or safe to be biopsied are eligible to enter the study.
•4. Measurable disease according to RECIST v1.1.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

排除标准

•1. Treatment with a nonpermitted drug/intervention as listed below:
•1.1. Concurrent anticancer treatment (e.g., cytoreductive therapy, radiotherapy, immune therapy, cytokine therapy, monoclonal antibody, or targeted small molecule therapy) or any study intervention within 4 weeks prior to start of study intervention, or not recovered from AEs related to such therapies
•1.2. History of prior dose reductions or dose interruptions while receiving cisplatin or carboplatin due to toxicity from the platinum or intolerance to either agent, unless discussed with and approved by the Sponsor Medical Monitor
•1.3. Prior treatment with a PD-1/PD-L1 targeting agent
•2. Current use of the following medications at the time of enrollment:
•2.1. Immunotherapy or immunosuppressive drugs at the time of enrollment (e.g., chemotherapy or systemic corticosteroids) EXCEPT for (a) intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra articular injection), (2) systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent, (3) steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication)
•2.2. Growth factors EXCEPT where indicated for treatment of study intervention related myelosuppression and for prophylaxis of repeat myelosuppression after initial occurrence
•2.3. Herbal remedies with immunostimulating properties (e.g., mistletoe extract) or known to potentially interfere with major organ function (e.g., hypericin)
•2.4. Other DNA damage repair inhibitors (except PARPi) (e.g., inhibitors of ATR, ataxia telangiectasia mutated [ATM] kinase, DNA-dependent protein kinase [DNA-PK], or Wee kinases).

研究者

发起方

Merck KGaA

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