A Phase 2, Multicenter, Open-Label Study of SCIB1 in Patients with Advanced Unresectable Melanoma Receiving Pembrolizumab - SCIB1 in melanoma patients receiving pembrolizumab SCIB1-002

Scancell Ltd0 个研究点目标入组 25 人开始时间: 2018年12月11日最近更新: 2019年12月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Scancell Ltd
入组人数: 25

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

入选标准

•Patients must meet the following criteria in order to be included in the study:
•1) Patient has histologically confirmed, unresectable Stage III or Stage IV melanoma as defined by the American Joint Committee on Cancer (AJCC) (Gershenwald et al 2017).
•2) Patient has not received prior systemic treatment for advanced disease. Prior adjuvant treatment, defined as treatment following resection of all detectable disease, is permitted; last dose must be at least 4 weeks before the first dose of SCIB1.
•3) Patient been clinically evaluated and pembrolizumab has been determined to be an appropriate treatment for their advanced disease.
•4) Patient’s BRAF status must be known; patients with BRAF mutation positive disease may be enrolled without BRAF-inhibitor treatment at the discretion of the Investigator, provided that they have no evidence of rapidly progressive disease (lactate dehydrogenase [LDH] above normal range, clinically significant tumor-related symptoms).
•5) Patient has at least one measurable lesion per RECIST 1.1 criteria by computed tomography (CT) scan or magnetic resonance imaging (MRI). Cutaneous and other superficial lesions are non-target lesions and are not considered measurable for the purposes of this protocol.
•6) Patient has an archival or fresh biopsy sample of tumor available for analysis of immunological markers including expression of programmed death-ligand 1 (PD-L1).
•7) Patient is HLA-A2 positive.*
•8) Patient is positive for HLA-DR4, HLA-DR7, HLA-DR53 or HLA-DQ6.*
•9) Patient is at least 18 years of age.
•10) Patient has a life expectancy of more than 3 months.
•11) Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•12) Patient has adequate organ function as determined by the protocol laboratory values.
•13) Patient must be able and willing to provide written IRB/REC-approved informed consent prior to any study-related procedure. In the event that the patient is re-screened for study participation or if a protocol amendment alters the care of an ongoing patient, a new IRB/REC-approved informed consent form (ICF) must be signed.
•14) Women of child-bearing potential (including women = 12 months from last menstrual period) must have a negative serum pregnancy test during Screening (within the 72 hr before planned administration of the first dose of study drug on Day 1) and be neither breastfeeding nor intending to become pregnant during study participation, and shall be warned of potential foetal harm from pembrolizumab. Women of childbearing potential must agree to use highly effective contraceptive methods prior to study entry, for the duration of study participation, and for 120 days after discontinuation of SCIB1 or pembrolizumab, whichever occurs last.
•15) Men who are potentially fertile with partners of childbearing potential must agree to use highly effective contraceptive methods for the duration of study participation and for 120 days after discontinuation of study treatment.
•16) Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
•* HLA testing will be conducted at accredited laboratories by molecular (DNA) typing.

排除标准

•A patient will not be eligible for the study if he/she meets one or more of the following criteria:
•1) Patient has a diagnosis of uveal or ocular melanoma.
•2) Patient has active central nervous system metastases or carcinomatous meningitis (patients with a response to previous treatment for brain metastases are eligible provided that they are stable without MRI evidence of progression for at least 4 weeks prior to the first dose of study treatment, and systemic steroids have been withdrawn for at least 2 weeks).
•3) Patient has previously received a treatment to block cytotoxic T lymphocyte (CTL)-associated protein 4 (CTLA-4), PD-1, PD-L1, or programmed death-ligand 2 (PD-L2) with the following exception: patients who have received adjuvant treatment with ipilimumab are eligible.
•4) Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.
•5) Patient is taking any systemic steroid therapy within one week of the first dose of study drug or is receiving any other form of immune suppressant medication. Topical steroids, such as those for the management of asthma, are permitted.
•6) Patient is receiving treatment with any investigational product within 28 days (or 5 half-lives of the treatment concerned if longer than 28 days) prior to the first dose of study treatment.
•7) Patient has a previous (within 5 years) or current malignancy with the exception of melanoma, and curatively treated local tumors such as carcinoma-in-situ of the breast, cervix, basal or squamous cell carcinoma of the skin, prostate cancer with Gleason grade < 6 and prostate specific antigen within normal range.
•8) Patient has a concurrent illness which would preclude study conduct and assessment, including, but not limited to uncontrolled medical conditions, uncontrolled and active infection (considered opportunistic, life threatening, or clinically significant), uncontrolled risk of bleeding, or uncontrolled diabetes mellitus, or pulmonary disease (including obstructive pulmonary disease, pulmonary fibrosis, and history of symptomatic bronchospasm), or alcoholic liver disease, or primary biliary cirrhosis. Caution should be used for patients with suspected or diagnosed epilepsy.
•9) Patient has any electronic stimulation device such as cardiac demand pacemaker, automatic implantable cardiac defibrillator, nerve stimulator or deep brain stimulator.
•10) Patient has a skin-fold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (deltoid or quadriceps muscles with intact lymph drainage) that is > 50 mm.
•11) Patient has New York Heart Association (NYHA) class III or IV heart disease, myocardial infarction within previous 6 months, a heart rate of = 50 beats per minute, a history of significant cardiac abnormality and/or clinically significant abnormal baseline ECG reading, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, uncontrolled hypertension (> 140/90 mm Hg), significant cerebrovascular disease, or congestive heart failure.
•12) Patient has a history of severe hypersensitivity reaction to treatment with a mAb.
•13) Patient has an active autoimmune disease

研究者

发起方

Scancell Ltd

相似试验

进行中（未招募）

1 期

A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative DisordersAnaemia associated with myelofibrosis whether as a de novo disorder (PMF) or evolve secondarily from previous PV or ET (post–PV MF or post–ET MF).MedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10074689Term: Post polycythemia vera myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10074690Term: Post essential thrombocythemia myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10074691Term: Post polycythaemia vera myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10074692Term: Post essential thrombocythaemia myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10077161Term: Primary myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2020-004029-21-ITINCYTE CORPORATIO100

招募中

1 期

JPRN-jRCT2031210445eda Eiji100

招募中

2 期

A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

2023-503624-83-00Incyte Corp.90

进行中（未招募）

1 期

A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy in Participants With Anemia Due to Myelodysplastic Syndromes or Multiple MyelomaParticipants who are transfusion-dependent or present with symptomatic anemiafor MDS participants who are ineligible to receive or have not responded to available therapies for anemia and for MM after failure of available standard treatments.MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: HLTClassification code 10028536Term: Myelodysplastic syndromesSystem Organ Class: 100000004851

EUCTR2020-002771-35-FRIncyte Corporation80

进行中（未招募）

1 期

EUCTR2020-002771-35-ITINCYTE CORPORATIO80