EUCTR2020-000397-18-FR进行中（未招募）1 期
A Multicentric, Open-Label, Single Arm Phase II Study To Evaluate The Efficacy And Safety Of The Combination Of PEmbrolizumab And Lenvatinib In Pre-Treated Thymic CArcinoma PaTIents. PECATI. - Phase II study of the combination of Pembrolizumab and Lenvatinib, in pre-treated thymic CArcinoma p
Medica Scientia Innovation Research S.L (MEDSIR)0 个研究点目标入组 43 人开始时间: 2021年5月17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
- 43
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
- All
入选标准
- •1.Relapsed / Recurrent histologically confirmed B3-Thymoma or TC patients not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD-L1 expression.
- •2.Patients progress after at least one previous line of platinum-based chemotherapy for advanced disease:
- •a.Patients treated with neo-adjuvant or adjuvant platinum-based chemotherapy combined with radical surgery or as part of radical chemo-radiotherapy are eligible if chemotherapy was completed within 6 months before enrolment.
- •3.Negative result for Myasthenia Gravis (MG) by acetylcholine receptor antibodies test. Presence of acetylcholine receptor antibodies will be considered a positive result for MG, regardless of the value.
- •4.Male/female who are at least 18 years of age on the day of signing informed consent.
- •5.ECOG performance status 0-1
- •6.Life expectancy = 3 months
- •7.Radiological progression documented per RECIST 1.1 during or after completion of previous line therapy, per investigator’s criteria.
- •8.Presence of measurable disease according to RECIST 1.1 criteria. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •a.Disease status must be documented by full chest and upper abdomen (including adrenal glands) CT and/or MRI within 28 days prior study enrolment. If clinically indicated, brain imaging must be performed;
- •9.Provides historical (obtained archived FFPE) or fresh tumor biopsy specimen for biomarker studies, if feasible. Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated is acceptable. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archival tissue. Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut.
- •10.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:
- •a)Not a woman of childbearing potential (WOCBP) as defined in Appendix 3
- •b) A 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.
- •11.Adequate bone marrow and organ function according to Table 1 (section 3.1.1).
- •12.Written informed consent prior to beginning specific protocol procedures.
- •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 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Has received 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).
- •2.Has received prior therapy with sunitinib.
- •3.Any evidence of active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable (i.e. without evidence of progression by imaging for at least four weeks prior to enrolment and any neurologic symptoms have returned to baseline), and have not received steroids (for a total equivalent dose of more than 10 mg of prednisone per day) for at least 7 days prior to enrolment.
- •4.Presence of acetylcholine receptor antibodies regardless of the value.
- •5.Uncontrolled blood pressure (Systolic BP>140 mmHg or diastolic BP >90 mmHg) in spite of an optimized regimen of antihypertensive medication.
- •6.Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at Screening.
- •7.Intratumor cavitation, direct invasion of main mediastinal blood vessels by the tumor or exist previous bleeding.
- •8.Fraction ejection < 50%
- •9.Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 15 days prior to enrolment:
- •a.Daily prednisone at doses up to 10 mg or equivalent doses of any other corticosteroid is allowed for example as replacement therapy;
- •10.History of interstitial lung disease (ILD) OR pneumonitis (other than COPD exacerbation) that has required oral or IV steroids;
- •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 (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed;
- •12.History of any other hematologic or primary solid tumor malignancy, unless in remission for at least 5 years and without specific treatment (as example, not allowed hormonal therapy to replace for breast cancer or hormonal therapy substitution in prostate cancer). pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non-melanomatous skin cancer or carcinoma in situ of the cervix are allowed;
- •13. Previous allogenic tissue/solid organ transplantation
- •14. Active infection requiring systemic therapy.
- •15. Has received prior radiotherapy within 2 weeks of start of study treatment.
- •16. Has an intestinal disease not allowing swallowing pills.
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