NL-OMON52693招募中2 期
eo-adjuvant nivolumab or nivolumab with ipilimumab in advanced cutaneous squamous cell carcinoma patients prior to standard of care surgery; the MATISSE trial - Neo-adjuvant IT in patients with advanced CSCC prior to SOC (MATISSE)
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age 18 years or older.
- •2. Patient is able to understand and comply with the protocol requirements and
- •has signed the informed consent form.
- •3. World Health Organization (WHO) Performance Status 0 or 1 (Appendix B).
- •4. Patients with histologically or cytologically confirmed, de novo/primary or
- •recurrent stage III-IVA CSCC (T3-4 N0-3 M0 or T0-2/x N1-3 M0) of all body
- •Primary tumor sites Head and Neck:
- •o Vermillion border lip: C00.0, C00.1, C00.2
- •o Skin of lip NOS: C44.0
- •o External ear: C44.2
- •o Skin face unspecified (ao: external lip and nasal vestibulum): C44.3
- •o Skin scalp and neck: C44.4
- •o Overlapping lesion of skin: C44.8
- •o Primary site eyelid: C44.1
- •CSCC outside head and neck area, but not vulva, anus and penis
- •Patients with histologically or cytologically proven stage I-II CSCC (T1-2 N0
- •M0), only in the case of:
- •Presence of multifocal disease for which extensive and/or mutilating surgery
- •is necessary (e.g. near-total scalp resection).
- •Situated in an anatomical localization that necessitates extensive and/or
- •mutilating surgery (e.g. orbital exenteration, (partial) nose amputation or
- •(partial) ear amputation).
- •5. Eligible for standard-of-care, curatively intended surgery with or without
- •adjuvant radiotherapy.
- •6. Screening laboratory values must meet the following criteria: WBC >= 2.0x109
- •/L, Neutrophils >=1.5x109 /L, Platelets >=100 x109 /L, Hemoglobin >=5.5 mmol/L,
- •Creatinine <=1.5x ULN, AST <= 1.5 x ULN, ALT <= 1.5 x ULN, Bilirubin <=1.5 X ULN
- •(except subjects with Gilbert Syndrome, who are eligible when total bilirubin <
- •3.0 mg/dL).
- •7. Women of childbearing potential (WOCBP) must use appropriate method(s) of
- •contraception. They should use an adequate method to avoid pregnancy for 23
- •weeks (30 days plus the time required for nivolumab to undergo five half-lives)
- •after the last dose of the investigational drug.
- •8. WOCBP must have a negative serum or urine pregnancy test (minimum
- •sensitivity 25IU/L or equivalent units of HCG) prior to the start of nivolumab
- •or nivolumab + ipilimumab.
- •9. Men who are sexually active with WOCBP must use a contraceptive method with
- •a failure rate of less than 1% per year and will be instructed to adhere to
- •contraception for a period of 31 weeks after the last dose of investigational
- •product. Surgically sterile or azoospermic men do not require aforementioned
- •contraception.
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •1. Distantly metastasized (stadium IVb) CSCC.
- •2. SCC localized in a mucosal surface (i.e. anus, vulva, penis or mucosal
- •portion of lip).
- •3. Patients for whom SOC consists of definitive (brachy)radiotherapy.
- •4. Primary or recurrent CSCC appearing in an area that has been previously
- •irradiated.
- •5. Prior anti-CTLA4 or anti-PD1 immunotherapy.
- •6. Active human immunodeficiency virus (HIV) or known acquired immunodeficiency
- •syndrome (AIDS).
- •7. A positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C
- •antibody (HCV Ab).
- •8. Subjects with any active autoimmune disease or a documented history of
- •autoimmune disease, except for:
- •Subjects with vitiligo
- •Resolved childhood asthma/atopy
- •Residual hypothyroidism due to an autoimmune condition requiring only hormone
- •replacement
- •Psoriasis not requiring systemic treatment
- •Any condition not expected to recur in the absence of an external trigger.
- •9. Underlying medical conditions that, in the investigator's opinion, will make
- •the administration of study drug hazardous or obscure the interpretation of
- •toxicity or AE.
- •10. A concurrent medical condition requiring the use of immunosuppressive
- •medications, or immunosuppressive doses of systemic or absorbable topical
- •corticosteroids;
- •11. Pregnant or nursing.
- •12. A history of allergy to study drug components and/or a history of severe
- •hypersensitivity to any monoclonal antibody.
- •13. Use of other investigational drugs 30 days before study drug administration
- •and 5 half times before study inclusion.
- •14. Use of prohibited medication at start of study period (see paragraph 5.2).
研究者
相似试验
进行中（未招募）
1 期
eo-adjuvant immunotherpy in patients with advanced CSCC prior to standard of care(MATISSE)EUCTR2020-001074-30-NLetherlands cancer institute (NKI) Antioni van Leeuwenhoek (AvL)40
进行中（未招募）
1 期
Ipilimumab in combination with Nivolumab followed by Nivolumab monotherapy in patients with unresectable or oligometastatic melanoma.Patients with histologically or cytologically confirmed AJCC (8th ed.) Stage IIIB -IV resectable melanoma.MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864EUCTR2018-002172-40-ITISTITUTO EUROPEO DI ONCOLOGIA35
进行中（未招募）
1 期
EOpredict-Lung is a clinical study in subjects with histologically or cytologically confirmed, early stage or locally advanced non-small cell lung cancer (NSCLC) eligible for curative resection. This study will determine the feasibility of two cycles of preoperative immunotherapy with nivolumab or as combination nivolumab plus relatlimab.non-small cell lung cancer (NSCLC) of clinical stages IB, II and selected stage III AMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002478-29-DEniversity Hospital Essen60
招募中
2 期
Neoadjuvant nivolumab combination treatment in resectable non-small cell lung cancer patients: Defining optimal combinations and determinants of immunological response (NEOpredict-Lung)2024-513074-22-00Universitaetsklinikum Essen AöR, Universitaetsklinikum Essen AöR90
进行中（未招募）
1 期
EOpredict-Lung is a clinical study in subjects with histologically or cytologically confirmed, early stage or locally advanced non-small cell lung cancer (NSCLC) eligible for curative resection. This study will determine the feasibility of two cycles of preoperative immunotherapy with nivolumab or as combination nivolumab plus relatlimab.non-small cell lung cancer (NSCLC) of clinical stages IB, II and selected stage III AMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002478-29-BEniversity Hospital Essen60