EUCTR2020-004649-35-IT进行中（未招募）1 期
Pembrolizumab and olaparib in recurrent/metastatic, platinum resistant nasopharyngeal cancer - POINT
Fondazione GONO0 个研究点目标入组 30 人开始时间: 2021年10月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- All
入选标准
- •1.Male/female participants who are at least 18 years old
- •2.The participant (or legally acceptable representative) provides written informed consent.
- •3.Histologically confirmed diagnosis of nasopharyngeal carcinoma.
- •4.Disease not amenable of surgical resection or irradiation with curative intent.
- •5.Disease progressing within 6 months since previous platinum-based systemic treatment (as concomitant to RT or as first line treatment for RM NPC).
- •6.Male participants:
- •A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 6 months (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.
- •Female participants:
- •A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
- •oNot a woman of childbearing potential (WOCBP) as defined in Appendix 3
- •oA WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 6 months after the last dose of study treatment.
- •7.Measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •8.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the start of study treatment.
- •9.Patients must have a life expectancy = 16 weeks.
- •10.Adequate organ function as defined in the following table (Table 5.1). Specimens must be collected within 10 days prior to the start of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1.WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •2.Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- •3.Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
- •4.Prior radiotherapy within 2 weeks of study intervention start. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
- •5.Received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- •7.Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- •8.Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- •9.Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided those are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
- •11.Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- •18.Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
- •19.Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- •20.Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study therapy is 2 weeks.
- •25.Has had an allogenic tissue/solid organ transplant.
研究者
相似试验
已完成
不适用
Durvalumab and Olaparib in Metastatic or recurrent Endometrial CancerAdvanced (recurrent, refractory or metastatic) Endometrial cancer or carcinosarcoma of the uterusNL-OMON20492eiden University Medical Center55
已完成
2 期
Olaparib Monotherapy and Olaparib + Pembrolizumab Combination Therapy for Ovarian CancerOvarian CancerJPRN-jRCT2080225217ational Cancer Center Hospital East30
已完成
1 期
Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine TumorsGastroenteropancreatic Neuroendocrine TumorsNCT03043664Duke University22
招募中
不适用
Phase II study of pembrolizumab in metastatic biliary tract cancer as second-line treatment after failing to at least one cytotoxic chemotherapy regimen: integration of genomic analysis to identify predictive molecular subtypesKCT0003948Samsung Medical Center33
尚未招募
Unknown
Pazopanib with or without Pembrolizumab for Sarcoma: open-label, multicenter, randomized, phase 2 trialsKCT0008625Yonsei University Health System, Severance Hospital116