single arm phase 2 trial

single arm phase 2 trial

18.12.2021, , 0

Patients with r/r ENKTL who failed to at least one asparaginase-based regimen were enrolled to receive sintilimab 200 mg intravenously every 3 weeks for up to 24 months. This was an open-label, multicentre, single-arm phase 2 trial done at 18 hospitals in Spain. Methods: Adults (≥18 years) with B-precursor ALL in hematologic CR (<5% blasts in bone marrow) after ≥3 intensive chemotherapy treatments and with MRD ≥10 -3 were eligible. Efficacy, toxicity, and quality‐of‐life outcomes of ... Study design and participants. The primary endpoint was confirmed objective response rate (ORR) by independent review per Response Evaluation Criteria in Solid Tumors V.1.1. In this multicentre, phase 2, single-arm study, patients aged 18 years or older with metastatic or surgically unresectable locally advanced urothelial carcinoma, measurable disease (according to Response Evaluation Criteria In Solid Tumors v1.1), Eastern Cooperative Oncology Group performance statuses of 0 or 1, and available tumour samples for biomarker analysis received nivolumab 3 . Methods: In this single-arm, single-centre, phase 2 trial, we recruited men (aged 18 years and older) with metastatic castration-resistant prostate cancer and progressive disease after standard treatments, including taxane-based chemotherapy and second-generation anti-androgens, from the Peter MacCallum Cancer Centre, Melbourne, VIC, Australia . They remain a mainstay today, particularly for trials in rare subgroups. The inclusion criteria were as follows: (1) age ≥21 years; (2) . Patient-reported quality of life after tisagenlecleucel infusion in children and young adults with relapsed or refractory B-cell acute lymphoblastic leukaemia: a global, single-arm, phase 2 trial. In this single-arm, phase 2 trial, adult patients (aged ≥18 years) diagnosed with confirmed metastatic or unresectable typical solitary fibrous tumour of any location, who had progressed in the previous 6 months (by Choi criteria or Response Evaluation Criteria in Solid Tumors [RECIST]) and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 were enrolled at 11 . Designing and interpreting single-arm studies based on four principles — instinct . Multiple-arm trials can be randomized or non-randomized with or without control arms. Preliminary results of single arm phase 2 trial of brigatinib in patients (pts) with progression disease (PD) after next-generation (NG) anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) in ALK + non-small cell lung cancer (NSCLC). The Lancet Oncology . A typical single-arm phase 2 trial enters 14 to 60 patients. The inclusion criteria were as follows: (1) age ≥21 years; (2) . Plasma ctDNA analysis before treatment may allow selection of patients who could benefit. TACE-HAIC Plus Lenvatinib for Patients With Unresectable HCC: an Open-label, Single-arm, Phase 2 Trial (Thalen) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The primary endpoint was the objec-tive response rate (ORR), which was determined by an METHODS Oncology trials that used Simon's two . Ridaforolimus as a single agent in advanced endometrial cancer: results of a single-arm, phase 2 trial. Tessa Therapeutics Announces Positive Data from Phase 2 Trial of Autologous CD30-CAR-T Therapy (TT11) in Relapsed or Refractory Classical Hodgkin Lymphoma at 2021 ASH Annual Meeting. Consequently, it is imperative such studies be designed, analyzed, and reported effectively. In this single-arm, phase 2 trial, adult patients with KRAS G12C-mutated advanced solid tumours were enrolled, from 59 medical centres in 11 countries, if they were aged 18 years or older, had at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, and had an Eastern Cooperative Oncology Group performance status of 1 or lower. As the primary purpose of these designs is the early stopping for futility, it is often the case that . Conclusions and Relevance The findings of this single-arm phase 2 trial suggest that cetuximab plus avelumab is an active, well tolerated rechallenge therapy in RAS WT mCRC. This study was an open-label, single-arm, phase 2 trial done at 38 clinics or hospitals in France, the UK, Australia, Canada, Poland, Italy, Ukraine, Germany, and the USA (appendix p 3).Patients with either EZH2 mut or EZH2 WT follicular lymphoma were enrolled into one of two follicular lymphoma cohorts (out of a total of six cohorts in the study; appendix p 10 . We enrolled patients aged 65 years or younger with previously untreated chronic lymphocytic leukaemia. A single-arm phase 2 trial (NIBIT-M1) investigated combination of ipilimumab plus fotemustine in 86 patients with metastatic melanoma, including 20 patients with asymptomatic brain metastases. This is the clinical trial including an open-label, single-arm Phase I study and a subsequent randomized, blind, placebo-parallel controlled Phase II study to evaluate the safety, immunogenicity and immune persistence of COVID-19 mRNA vaccine in healthy people aged 18-60 years and ≥18 years respectively, whose locations or circumstances put them at appreciable risk of acquiring COVID-19 and . Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. Epub 2019 Oct 9. Methods: We did a multicentre, open-label, non-randomised, single-arm phase 2 trial at seven sites in the USA. UHF-RT regimens were 36.25 Gy (Cohort A) and 37.5 Gy (Cohort B) delivered in five fractions every other day over 1.5-2.5 weeks. Therefore, when a single-arm design is adopted in a phase II trial setting, which may be due to limited patient availability or studies investigating a therapy with only a single agent , it would be a superior choice for drug screening in phase II clinical trials. The study will enroll approximately 140 patients This was a prospective, single-arm phase II trial conducted at the National Cancer Centre Singapore (NCCS). We did a multicentre (28 hospital sites in the USA, UK, Italy, and Switzerland), open-label, single-arm, phase 2 trial (LOTIS-2) in patients aged 18 years or older with relapsed or refractory DLBCL after two or more multiagent systemic treatments, who had measurable disease and Eastern Cooperative Oncology Group performance status 0-2. An increasing fraction of patients with metastatic cancer develop leptomeningeal dissemination of disease (LMD), and survival is dismal 1-3.We conducted a single-arm, phase 2 study of pembrolizumab in patients with solid tumor malignancies and LMD (NCT02886585).Patients received 200 mg of pembrolizumab intravenously every 3 weeks until definitive progression or unacceptable toxicity. Material and methods The study was a single-arm, open-label, phase 2 trial in patients with unresectable, relapsed osteosarcoma. 6 , e12 . We report the outcomes of a single-arm, phase II trial of UHF-RT from an Asian center. Transarterial Infusion of PD-1 Antibody Plus TACE-HAIC for Unresectable HCC: a Single-arm, Phase 2 Clinical Trial (AIPD-1) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Chu et al. Our initial cohort (original cohort) was not restricted by prognostic marker status and included patients who had del(17p) or TP53 . In this single-arm, phase 2 trial, adult patients with KRAS G12C-mutated advanced solid tumours were enrolled, from 59 medical centres in 11 countries, if they were aged 18 years or older, had at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, and had an Eastern Cooperative Oncology Group performance status of 1 or lower. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. There are limited data in Asian cohorts. IMvigor210 was a multicentre, single-arm, 2-cohort phase 2 trial that investigated efficacy and safety of atezolizumab in mUC. ORIENT-4 is a multicenter, single-arm, phase 2 clinical trial (NCT03228836). Methods We conducted a single-arm, phase II trial with patients with rNPC who had biopsy-proven disease and were . This single-arm, phase 2, feasibility trial was done at one centre in the USA (The MD Anderson Cancer Center, Houston, TX, USA). Sharma P, Retz MM, Siefker-Radtke A, Baron AD, Necchi A, Bedke J et al. 2019 May;20(5):636-648. doi: 10.1016/S1470-2045(19)30029-4. The SWORD trial is the first multicenter, single arm, phase II study assessing the safety and efficacy of a PD-1 inhibitor (Sintilimab), stereotactic body radiotherapy (SBRT) and granulocyte-macrophage colony stimulating factor (GM-CSF) in advanced non-small cell lung cancer (NSCLC) without sensitizing driver mutations. Safety and activity of sintilimab in patients with relapsed or refractory classical Hodgkin lymphoma (ORIENT-1): a multicentre, single-arm, phase 2 trial. METHODS Oncology trials that used Simon's two . In this single-arm, phase 2 trial, adult patients with KRAS G12C-mutated advanced solid tumours were enrolled, from 59 medical centres in 11 countries, if they were aged 18 years or older, had at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, and had an Eastern Cooperative Oncology Group performance status of 1 or lower. Historically, single-arm phase 2 trials have been used in oncology in order to confirm tolerability and safety observed in phase 1, and to obtain evidence of activity in specific histological types. Lancet Haematol. In this paper, we propose new methods for a single arm Phase II study, which provide practical strategies for testing if there is an improvement of median survivals from a new drug compared to the standard therapy. Phase II single-arm two-stage designs are typically used to determine whether a drug is sufficiently efficacious to move on a randomized phase III trial. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial Lancet Oncol. We comprehensively review such trials to examine whether this is the case. Methods: ORIENT-1 (NCT03114683) is a multicenter, single-arm, phase 2 study. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Aim To evaluate the activity and safety of the PD-1 antibody pembrolizumab in adult patients with advanced osteosarcoma. agents, and the absence of prospective trials that include solitary fibrous tumours, we designed a single-arm, phase 2 trial to investigate the activity of the antiangiogenic pazopanib in solitary fibrous tumour. PATHFINDER (ClinicalTrials.gov identifier no. LBA55 - Primary analysis of a phase II single-arm trial of trastuzumab deruxtecan (T-DXd) in western patients (Pts) with HER2-positive (HER2+) unresectable or metastatic gastric or gastroesophageal junction (GEJ) cancer who progressed on or after a trastuzumab-containing regimen Single-arm or non-randomized trials ,in which everyone enrolled in a trial receives the experimental therapy, are common in Phase 1 and 2 testing. prospective, multicenter, single-arm, open-label, phase 2 trial conducted by the HANSHIN Oncology Group to evaluate the clinical efficacy and safety of afatinib- bevacizumab combination therapy after AR in -EGFR mutant NSCLC. 7 Such studies fall into three main groups, including randomized selection design ("pick the winner"), in which the best of two or more . Methods: We did a multicentre (28 hospital sites in the USA, UK, Italy, and Switzerland), open-label, single-arm, phase 2 trial (LOTIS-2) in patients aged 18 years or older with relapsed or refractory DLBCL after two or more multiagent systemic treatments, who had measurable disease and Eastern Cooperative Oncology Group performance status 0-2 . A multinational efort was thus activated by Italian, French, and Spanish sarcoma groups. Single-arm trials a good step towards faster access/reimbursement of drugs? Methods: For this multicentre, single-arm, two-cohort, phase 2 trial, patients (aged ≥18 years) with inoperable locally advanced or metastatic urothelial carcinoma whose disease had progressed after previous platinum-based chemotherapy were enrolled from 70 major academic medical centres and community oncology practices in Europe and North . Enasidenib plus azacitidine versus azacitidine alone in patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia (AG221-AML-005): a single-arm, phase 1b and randomised, phase 2 trial Previous Article Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA . Eligible patients were aged 18 years or older with histologically or cytologically documented treatment-naive American Joint Committee on Cancer-defined stage IIIA NSCLC that was deemed locally to be surgically resectable by a multidisciplinary clinical team, and an Eastern Cooperative Oncology Group . 4 These sample sizes severely limit the number of new therapies that can be studied. The agents that are studied in phase 2 are thus those thought a priori to be particularly promising. Key eligibility criteria were aged 12 years or older, Eastern Cooperative Oncology Group performance status of 0-1, and documented disease progression (according to . Methods. We did a multicentre (28 hospital sites in the USA, UK, Italy, and Switzerland), open-label, single-arm, phase 2 trial (LOTIS-2) in patients aged 18 years or older with relapsed or refractory DLBCL after two or more multiagent systemic treatments, who had measurable disease and Eastern Cooperative Oncology Group performance status 0-2. This is a Phase 2, multi-center, open-label, single-arm study of the efficacy and safety of loncastuximab tesirine used as monotherapy in patients with relapsed or refractory DLBCL. Lancet Oncol. An increasing fraction of patients with metastatic cancer develop leptomeningeal dissemination of disease (LMD), and survival is dismal 1-3.We conducted a single-arm, phase 2 study of pembrolizumab in patients with solid tumor malignancies and LMD (NCT02886585). Design, Setting, and Participants The TOPACIO/KEYNOTE-162 (Niraparib in Combination With Pembrolizumab in Patients With Triple-Negative Breast Cancer or Ovarian Cancer) trial, an open-label, single-arm phases 1 and 2 study enrolled women with advanced or metastatic triple-negative breast cancer (TNBC) or recurrent ovarian carcinoma . Phase II Clinical Trial . Early stage Phase 2 clinical trials are often designed as multi-stage single arm trials, which quickly identify inefficacious molecules and interventions, without subjecting too many patients to treatments with questionable standard of care. Methods. The primary endpoint was the objective response rate (ORR) based on Lugano 2014 criteria. NCT03580655) is an ongoing, international, multicenter, open-label, single-arm, phase 2 registrational trial conducted in North America and Europe . We comprehensively review such trials to examine whether this is the case. A single-arm, single-blind, phase 2a study of the neuromodulating drug RL-007, initiated by biopharmaceutical company atai Life Sciences, revealed its effectiveness in improving cognitive function . This ABC (Afatinib Plus Bevacizumab Combination After Acquired Resistance to EGFR TKIs in EGFR-Mutant Non-Small Cell Lung Cancer) study was a prospective, multicenter, single-arm, open-label, phase 2 trial conducted by the HANSHIN Oncology Group to evaluate the clinical efficacy and safety of afatinib-bevacizumab combination therapy after AR . Study design. Consequently, it is imperative such studies be designed, analyzed, and reported effectively. suggested superiority of the longer 10-day regimen of decitabine which has shown promising results in high-risk AML in phase 2 trials. 2.1 Study Design This is a single-arm Phase 2 study in subjects ≥ 18 years old with relapsed FL after failure of at least two prior lines of therapy (each containing rituximab and/or an alkylating agent). Methods. 2017 Mar 1;18(3):312-322. Patients with histologically confirmed, nonmetastatic prostate adenocarcinoma were eligible. Methods. METHODS: We recruited men with histologically confirmed, nonmetastatic localized PCa. A Phase II Single-arm Intervention Trial of Nelfinavir in Patients With Grade 2/3 or 3 Cervical Intraepithelial Neoplasia. Introduction: The main goal of Phase II clinical trials is to identify the therapeutic efficacy of new treatments.They are usually single-arm studies, but may take the form of multiple-arm trials. Methods. The primary endpoint was clinical benefit rate (CBR) at 18 weeks of treatment, defined as complete response, partial response, or stable disease . A multi-center, open-label, single-arm, phase 2 QUADRA trial observed that 10 (27%) of 37 platinumresistant patients harbored BRCA mutation, 12 (10%) of 120 platinum-resistant patients with HRD . Ten-day Decitabine with Venetoclax in Acute Myeloid Leukemia: A Single-arm Phase 2 Trial. Oral poster . Eligible patients were aged 18 years or older with histologically or cytologically documented treatment-naive American Joint Committee on Cancer-defined stage IIIA NSCLC that was deemed locally to be surgically resectable by a multidisciplinary clinical team, and an Eastern Cooperative . Methods: We did an open-label, multicentre, single-arm, phase 2 trial across 38 outpatient clinics, primarily at academic medical centres, in Canada, Europe, and the USA. [ 23] proposes the design for immunotherapy trials with random delayed treatment effect based on survival time. Our initial cohort (original cohort) was not restricted by prognostic marker status and included patients who had del(17p) or TP53 . Please remove one or more studies before adding more. Patients (aged ≥18 years) with five or fewer metastatic lesions, an Eastern Cooperative Oncology Group status of 0-2, and no more than one previous systemic therapy (if this therapy was stopped at least 1 month before enrolment) without limitations on . PURPOSE Two-stage single-arm designs have historically been the most common design used in phase II oncology. Oral poster highlights data from 14 heavily pre-treated patients enrolled in pilot stage of multicenter, open-label, single arm CHARIOT study to evaluate safety and efficacy of TT11 TT11 . We conducted a single-arm, phase 2 study of . Patients who failed 2 or more lines of systemic therapy, including autologous hematopoietic stem cell transplantation (HSCT) were enrolled. A safety run-in phase was conducted to determine the tolerability of the . This international, single-arm, phase 2 trial was done in 24 hospitals in Italy, the UK, the Netherlands, and Switzerland. They remain a mainstay today, particularly for trials in rare subgroups. This was an open-label, multicentre, single-arm phase 2 trial done at 18 hospitals in Spain. Eligible patients (aged ≥18 years and with an Eastern Cooperative Oncology Group performance status of 0 or 1) with a histologically confirmed diagnosis of metastatic basal . Study design and participants. . An increasing fraction of patients with metastatic cancer develop leptomeningeal dissemination of disease (LMD), and survival is dismal1-3. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. While Phase 3 trials are frequently randomized in order to provide more precise data on safety and effectiveness outcomes, a Phase 3 trial might use a single arm if a small target population makes . The randomized phase II trial is a well-known platform for testing the efficacy of novel agents in oncology, with the potential of minimizing some of the pitfalls inherent in the single arm phase II design. We aimed to investigate the efficacy and safety of toripalimab in combination with intensity-modulated radiotherapy (IMRT) for recurrent nasopharyngeal carcinoma (rNPC). We enrolled patients aged 65 years or younger with previously untreated chronic lymphocytic leukaemia. 2019 Dec;20(12):1710-1718. doi: 10.1016/S1470-2045(19)30493-. In this phase 2, single-arm, multicentre, open-label study, patients were enrolled at 40 sites in ten countries (Australia, Belgium, Czech Republic, France, Italy, the Netherlands, Poland, Spain, the UK, and the USA). We hypothesized that venetoclax with 10-day decitabine may be effective in ND and relapsed/refractory (R/R) AML . The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Approximately 90 subjects will be treated with nivolumab 3mg/kg IV every 2 weeks. This trial was conducted in 47 academic medical centres and community oncology practices across 7 countries, in North America and Europe. Authors Kathleen N Moore 1 . (with an added value for 'all' patient…) Mattias Neyt, MSc, PhD Senior health economist mattias.neyt@kce.fgov.be EMA, 30 June 2016 Toripalimab plus paclitaxel and carboplatin as neoadjuvant therapy in patients with locally advanced resectable esophageal squamous carcinoma: An open-label, single arm phase 2 trial [abstract]. Methods. Methods: We did a multicentre, open-label, non-randomised, single-arm phase 2 trial at seven sites in the USA. In this open-label, single-arm phase I/II trial, 87 patients with r/rNHL, including 58 patients with aggressive diffuse large B-cell lymphoma and 24 with high tumour burden, received an infusion . PURPOSE Two-stage single-arm designs have historically been the most common design used in phase II oncology. Adults (aged 18-70 years) with histologically diagnosed diffuse large B-cell lymphoma and CNS involvement at the time of primary diagnosis or at relapse and Eastern Cooperative Oncology Group Performance Status of 3 or less were enrolled and received three courses of . The clinical and translational results of N Colombo 1, D S McMeekin 2, P E Schwartz 3, C Sessa 4, P A Gehrig 5, R Holloway 6, P Braly . Shi, Y. et al. Patients with histologically confirmed, nonmetastatic prostate adenocarcinoma were eligible. Trial Registration ClinicalTrials.gov Identifier: NCT04561336 The phase 1b dose-escalation part of the trial assessed two enasidenib doses—100 mg or 200 mg per day—each in combination with subcutaneous azacitidine 75 mg/m 2 per day, to establish the recommended combination dose of enasidenib for the randomised phase 2 study portion. Background Toripalimab is a humanized immunoglobulin G4 monoclonal antibody against programmed death 1. Methods: We did a multicentre, single-arm, two-stage, phase 2 trial in patients with advanced Ewing sarcoma or osteosarcoma recruited from ten centres in the French Sarcoma Group. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Methods In a cohort of this single-arm, phase 2 trial (JAVELIN Merkel 200), patients with mMCC and disease progression after prior chemotherapy received avelumab 10 mg/kg intravenously every 2 weeks. : ( 1 ) age ≥21 years ; ( 2 ) randomized 2! To be particularly promising we report the outcomes of... < /a methods! Was confirmed objective response rate ( ORR ) based on four principles — instinct hematopoietic stem transplantation! Sample sizes severely limit the number of new therapies that can be or! 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