治験一覧
8,963 件中 3281〜3300 件を表示
プログラム細胞死リガンド1（PD-L1）陽性再発性または転移性頭頸部扁平上皮癌（R/M HNSCC）患者を対象とした、ペンブロリズマブ（MK-3475）とレンバチニブ（E7080/MK-7902）の併用または非併用による一次治療（1L）試験（MK-7902-010）（KEYNOTE-010）
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).
肺動脈性高血圧症（PAH）患者におけるマシテンタンとタダラフィルの単剤療法と対応する固定用量併用療法の有効性と安全性を比較する臨床試験
Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.
転移性非扁平上皮非小細胞肺がん成人患者における第一選択介入としてのペメトレキセド＋プラチナ製剤化学療法＋ペンブロリズマブ（MK-3475）とレンバチニブ（MK-7902/E7080）の併用または非併用の安全性および有効性試験（MK-7902-006/E7080-G000-315/LEAP-006）
The purpose of this study is to assess the safety and efficacy of pemetrexed + platinum chemotherapy + pembrolizumab (MK-3475) with or without lenvatinib (MK-7902/E7080) as first-line intervention in adults with metastatic nonsquamous non-small cell lung cancer. The primary study hypotheses state that: 1) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Progression-free Survival (PFS) as assessed by blinded independent central review (BICR) per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST 1.1) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab, and 2) the combination of lenvatinib + platinum doublet chemotherapy + pembrolizumab prolongs Overall Survival (OS) compared to matching placebo + platinum doublet chemotherapy + pembrolizumab.
中等度から重度の化膿性汗腺炎の成人患者を対象とした、リサンキズマブとプラセボを比較する国際共同研究
The primary objective of this study is to assess the safety and efficacy of risankizumab 180 mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before the Baseline visit.
小児長期追跡調査およびロールオーバー研究
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
経口摂取が困難または不可能なうっ血性心不全患者におけるOPC-61815注射剤の安全性試験
To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once daily for a maximum of 5 days to CHF patients with volume overload despite having received diuretics (injection) other than vasopressin antagonists and who have difficulty with or are incapable of oral intake.
ファブリー病患者におけるミガラスタットの評価研究（GLA変異および腎疾患）
An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects with Fabry Disease and Amenable GLA Variants and Severe Renal Impairment (SRI) or End Stage Renal Disease (ESRD)
片頭痛を有する日本人参加者を対象とした、単回の片頭痛発作に対するラスミジタン（LY573144）の効果に関する研究
This study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in Japanese adult participants with or without aura.
進行非小細胞肺癌患者を対象とした第2相プラットフォーム試験（ORCHARD試験）（一次治療としてオシメルチニブを投与された後に病勢進行が認められた患者を対象とした試験）
Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple study treatments.
未熟児網膜症に対するアフリベルセプト - 硝子体内注射とレーザー治療の比較
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.
非ホジキンリンパ腫（NHL）および慢性リンパ性白血病（CLL）患者を対象としたJNJ-67856633の研究
The purpose of this study is to determine the recommended Phase 2 dose regimen or the maximum tolerated dose of JNJ-67856633 in participants with relapsed/ refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia.
転移性非扁平上皮非小細胞肺癌の一次治療患者を対象とした、ペメトレキセド＋プラチナ製剤併用化学療法（ペムブロリズマブ（MK-3475）併用または非併用）（MK-3475-189/KEYNOTE-189）－日本延長試験
This is a Japan Extension Study of Global Study MK-3475-189 (NCT02578680). This is an efficacy and safety study of pembrolizumab (MK-3475) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in adult Japanese participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned to receive pembrolizumab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin). With Amendment 11 (effective date 31-Jan-2022), once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. The primary hypothesis is that pembrolizumab in combination with pemetrexed/platinum chemotherapy prolongs Progression-Free Survival (PFS) and Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.
転移性大腸癌（mCRC）患者を対象とした、ニボルマブ、ニボルマブ＋イピリムマブ、または治験担当医選択化学療法によるミスマッチ修復欠損（dMMR）／マイクロサテライト不安定性高値（MSI-H）の治療に関する研究
The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.
温性自己免疫性溶血性貧血の成人におけるM281の有効性と安全性
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
口腔扁平上皮癌切除および薬剤誘発性骨壊死後の下顎骨部分欠損再建術を受けた患者に関するデータ収集のためのレジストリ
Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.
エフィサイル™ 1：全身性膿疱性乾癬と呼ばれる皮膚疾患の再発患者におけるスペソリマブ（BI 655130）の有効性を評価する試験
To evaluate efficacy, safety, and tolerability of spesolimab (BI 655130) compared to placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.
再生不良性貧血患者におけるAMG531（ロミプロスチム）の研究
To evaluate the hematological responses based on the response assessment criteria when AMG531 is subcutaneous (SC)-administered with anti-human thymocyte immunoglobulin (ATG) + ciclosporin A (CsA) therapy for 6 months in patients with aplastic anemia (AA) who were previously untreated with immunosuppressive therapy.
再発・難治性びまん性大細胞型B細胞リンパ腫患者を対象とした、OPB-111077とベンタムスチンおよびリツキシマブの併用療法に関する第1相臨床試験
To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.
プログラム細胞死受容体1リガンド1（PD-L1）陽性の再発性または転移性頭頸部扁平上皮癌におけるGSK3359609とペムブロリズマブの併用療法に関する研究
The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) \>=1 R/M HNSCC.
中等度から重度の活動性クローン病の成人患者に対する経口エトラシモドの有効性と安全性を評価する研究
This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.