EUCTR2016-002260-14-FR进行中（未招募）1 期
Secured access to pembrolizumab for adult patients with selected rare cancer types. - AcSé Pembrolizumab
ICANCER0 个研究点开始时间: 2017年4月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients must meet all of the following criteria to be included in the study:
- •1. Patient information sheet and written informed consent form signed.
- •2. Histologically confirmed diagnosis of a pathology corresponding to one of the following selected cancer types:
- •-Rare sarcoma: Alveolar soft part sarcoma, Chordoma, Dedifferentiated chondrosarcoma, epithelioid sarcoma, sarcoma with loss of INI1, malignant rhabdoid tumours, myxoid liposarcoma, angiosarcoma of the scalp, radiation induced sarcomas.
- •-Rare ovarian cancer: recurrent or relapsed; sex cord tumour, germ cell tumour (immature teratoma, non seminomatous germ cell & dysgerminoma), low-grade serous carcinoma, mucinous carcinoma, clear cell adenocarcinoma, small cell carcinoma, and carcinosarcoma – with histological confirmation following review by members of the Tumeurs Malignes Rares Gynécologiques (TMRG) network (French rare gynaecological tumour group)
- •-Primary central nervous system lymphoma: refractory primary intraocular and CNS lymphoma.
- •-Rare thyroid cancer: differentiated thyroid carcinoma (Papillary, follicular, Hurthle cell (oncocytic), poorly differentiated thyroid carcinoma), medullary thyroid carcinoma, anaplastic thyroid carcinoma.
- •-Rare malignant neuroendocrine cancer: poorly differentiated tumours refractory after 2 lines of chemotherapy, well differentiated tumours refractory after 4 lines of treatment, carcinoid tumours after 2 lines of treatment.
- •-Germ-cell cancer progressing after standard therapy.
- •3. Metastatic disease or unresectable locally advanced malignancy that is resistant or refractory to standard therapy or for which standard therapy does not exist or is not considered appropriate by the Investigator.
- •4. Aged = 18 years old.
- •5. Measurable disease according to RECIST v1.1 guidelines for solid tumours (Eisenhauer, 2009); or IPCG response criteria (Abrey, 2005) for patients in the PCNSL cohort. For patients with germ-cell cancer measurable disease is defined as measurable according to RECIST v1.1 and / or abnormal levels of AFP, hCG and LDH.
- •6. Able to provide a FFPE biopsy sample of a metastatic site or primitive tumour tissue.
- •Note: Patients for whom suitable archived biopsy material is not available must be willing to undergo a biopsy of a tumour lesion prior to study entry, unless this is medically contraindicated (e.g. site inaccessible or patient safety concerns).
- •7. Patients must have a mandatory treatment-free interval of at least 21 days following previous systemic anti-cancer treatments.
- •8. Patients who have received previous systemic anticancer treatment and/or radiotherapy should have recovered from any treatment related toxicity, to a level of = grade 1 (according to National Cancer Institute [NCI] common terminology criteria for adverse events, version 4 (CTCAE v4) with the exception of Grade 2 alopecia.
- •9. Adequate hematologic function (absolute neutrophil count = 1.0 x109/L, platelets = 100 x109/L, haemoglobin = 9 g/L) measured within 14 days of treatment initiation.
- •10. Adequate renal function (creatinine clearance = 50 mL/min using the MDRD or CKI EPI method) measured within 14 days of treatment initiation.
- •11. Adequate hepatic function (serum bilirubin = 1.5 xULN unless due to Gilbert’s syndrome; aspartate aminotransferase [ASAT] and alanine aminotransferase [ALAT] = 3 xULN) measured within 14 days of treatment initiation. For patients with documented liver metastasis ASAT/ALAT = 5x ULN is acceptable.
排除标准
- •Patients meeting any of the following criteria will be excluded from participation in the study:
- •1. Prior treatment with an anti-PD1 or anti-PD-L1 antibody.
- •2. Eligible, and willing, to participate in a clinical trial of an alternative anticancer therapy targeting their disease, which is open to accrual in France.
- •3. Concurrent steroid medication at a dose greater than prednisone 10 mg/day or equivalent. For patients with PCNSL or germ-cell cancer, concurrent steroid medication at a dose greater than prednisone 20 mg/day or equivalent.
- •4. Has 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 (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •5. History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
- •6. History of severe hypersensitivity reaction to any monoclonal antibody therapy
- •7. Radiotherapy (except for brain and extremities) within 21 days prior to the first administration of IP.
- •8. Treatment with other investigational drugs or participation in another clinical trial within 21 days prior to the first administration of IP or concomitantly with the trial.
- •9. Has known symptomatic central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
- •10. Has known carcinomatous meningitis or a history of leptomeningeal disease except for patients with primary CNS lymphoma.
- •11. Serum creatinine > 1.5 xULN or glomerular filtration rate < 50 ml/min.
- •12. Lymphocytes count below 1,000/mm3 and CD4+ count below 500/mm3 as assessed by routine blood phenotyping.
- •13. Other malignancies within the past 5 years other than basal cell skin cancer or in situ carcinoma of the cervix.
- •14. Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy.
- •15. Active or chronic hepatitis B, hepatitis C and/or human immunodeficiency virus infection (HIV 1/2 antibodies), or a known history of active Tuberculosis bacillus.
- •16. Live vaccine received within 30 days of planned start of study treatment.
- •Note: Seasonal influenza vaccines for injection are generally inactivated vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.
- •17. Active alcohol or drug abuse.
- •18. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.
- •19. Any condition which in the Investigator’s opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
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