protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04085328 | 8.2 | Exclusion Criteria | 8.2 Exclusion Criteria Subjects fulfilling any of the following criteria are not eligible for participation in this study. | 1. | Any anterior segment infection, inflammation, or abnormality or disease (including | |----|----------------------------------------------------------------------------------------| | | syste... | [] |
NCT04085328 | 8.3 | Rescreening of Subjects | 8.3 Rescreening of Subjects Rescreening of subjects is not allowed in this study. | [] |
NCT04085328 | 9 | TREATMENTS ADMINISTERED | 9 TREATMENTS ADMINISTERED | [] |
NCT04085328 | 9.1 | Investigational Product(s) | 9.1 Investigational Product(s) Test Product(s): soft contact lenses Control Product(s) (If applicable): Biofinity (comfilcon A) soft contact lenses Table 9–1 Test Product | Test Product | soft contact lenses (contact lens)(LID015385) | |-----------------------------------------------------------------------|-----------... | [
"Table 9–2 Control Product"
] |
NCT04085328 | 9.2 | Other Medical Device or Medication Specified for Use During the Study | 9.2 Other Medical Device or Medication Specified for Use During the Study Other than the pre-specified CLEAR CARE, LacriPure (or equivalent), Systane rewetting drops, and OFPM MPDS, no other medical devices or medications are required to be used in conjunction with the treatments during the clinical study. | [] |
NCT04085328 | 9.3 | Treatment Assignment / Randomization | 9.3 Treatment Assignment / Randomization  Only after signing the ICF, a subject will be assigned a subject number by the electronic data capture system. A randomization list will be generated using a validated system that automates the random assignment of treatment arms to randomization numbers ... | [] |
NCT04085328 | 9.4 | Treatment masking | 9.4 Treatment masking | This study is double-masked, with subjects randomized to use | or Biofinitycontact | |--------------------------------------------------------------|-------------------------| | lenses for the duration of the 12-monthtreatment period. | | | | | | | |  Document: TDOC-005575... | [] |
NCT04085328 | 9.5 | Accountability Procedures | 9.5 Accountability Procedures Upon receipt of the IPs, the Investigator or delegate must conduct an inventory. During the study, unmasked designated study staff must provide the IPs to the subjects in accordance with their randomization assignment. Throughout the study, the unmasked designated study staff must maintain... | [] |
NCT04085328 | 9.6 | Changes to concomitant medications, treatments/ procedures | 9.6 Changes to concomitant medications, treatments/ procedures After the subject is enrolled into the study, the Investigator must instruct the subject to notify the study site about: Document: Version: Page 55 of 78 Status: Effective TDOC-0055758 5.0; Most-Recent; Effective; CURRENT Protocol - Clinical 16-Jan-2020 - A... | [] |
NCT04085328 | 10 | STUDY PROCEDURES AND ASSESSMENTS | 10 STUDY PROCEDURES AND ASSESSMENTS Subjects will be expected to attend 9 office visits, as shown in Table 10-1. Table 10–1 Study Visits | Visit # | Visit Type | Visit Day | Visit Window | |---------|---------------------------------|-----------|-----------------| | Visit 1 | Baseline/Dispense | Day 1 | N/A | | Visit 2... | [] |
NCT04085328 | 10.1 | Informed Consent and Screening | 10.1 Informed Consent and Screening The Investigator or delegate must explain the purpose and nature of the study, and have the subject read, sign, and date the IRB/IEC-approved informed consent document. The subject must sign the ICF BEFORE any study-specific procedures or assessments can be performed, including study... | [] |
NCT04085328 | 10.2 | Description of Study Procedures and Assessments | 10.2 Description of Study Procedures and Assessments Detailed descriptions of assessments and procedures are provided in the MOP. The Investigator is responsible for ensuring responsibilities for all procedures and assessments are delegated to appropriately qualified site personnel. Document: Version: Page 57 of 78 Sta... | [] |
NCT04085328 | 10.2.1 | Demographics | 10.2.1 Demographics Obtain demographic information including age, race, ethnicity, and sex. | [] |
NCT04085328 | 10.2.2 | Medical History | 10.2.2 Medical History Collect medical history information, including information on all medications used within the past 30 days. Include herbal therapies, vitamins, and all over-the-counter as well as prescription medications. Throughout the subject's participation, obtain information on any changes in medical health... | [] |
NCT04085328 | 10.2.3 | Investigational Product compliance | 10.2.3 Investigational Product compliance Review subject compliance with the IP usage and adjunct product usage and collect all used and unused study IPs and other products that were dispensed. | [] |
NCT04085328 | 10.2.4 | Adverse Event Collection: Safety Assessment | 10.2.4 Adverse Event Collection: Safety Assessment Assess and record any AEs that are observed or reported, including those associated with changes in concomitant medication dosing since the previous visit. | [] |
NCT04085328 | 10.2.5 | Slit-Lamp Biomicroscopy: Safety Assessment | 10.2.5 Slit-Lamp Biomicroscopy: Safety Assessment Slit-lamp examination of the cornea, iris/anterior chamber and lens must be performed in both eyes before instillation of any diagnostic eye drops. | [] |
NCT04085328 | 10.2.6 | Device Deficiencies: Safety Assessment | 10.2.6 Device Deficiencies: Safety Assessment Assess and record any device deficiencies that are reported or observed, including those associated with changes in concomitant medication dosing since the previous visit. Requirements for reporting device deficiencies in the study can be found in Section 11. | [] |
NCT04085328 | 10.3 | Additional Study Assessments: Effectiveness and Safety Assessment | 10.3 Additional Study Assessments: Effectiveness and Safety Assessment The following are additional study assessments. Refer to the MOP for further details. - Distance VA with study lenses (Snellen) - Distance VA with habitual correction (Snellen) - Manifest refraction Keratometry Document: Version: Page 58 of 78 Statu... | [] |
NCT04085328 | 10.4 | Unscheduled Visits | 10.4 Unscheduled Visits If a subject visit occurs between any regularly scheduled visits, this visit must be documented as an Unscheduled Visit. During all unscheduled visits, the Investigator must conduct the following procedures: - Collect AE information, as applicable - Record changes in medical condition or concomi... | [] |
NCT04085328 | 10.5 | Discontinued Subjects | 10.5 Discontinued Subjects | [] |
NCT04085328 | 10.5.1 | Screen Failures | 10.5.1 Screen Failures Screen failures are subjects who were excluded from the study after signing the informed consent, not meeting the inclusion/exclusion criteria, and prior to randomization to product/dispense of study product. The Investigator must document the reason for screen failure in the subject's case histo... | [] |
NCT04085328 | 10.5.2 | Discontinuations | 10.5.2 Discontinuations Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the study by the Investigator after signing the informed consent. Subject numbers of discontinued subjects must not be re-used. Subjects may discontinue from study or study treatment at any time for any reason. ... | [] |
NCT04085328 | 10.5.3 | Schedule of Procedures and Assessments for Subjects Discontinued from Investigational Product | 10.5.3 Schedule of Procedures and Assessments for Subjects Discontinued from Investigational Product Other than screen failures, if a subject discontinues from the study, the subject should undergo an Early Exit Visit. Refer to Table 3-1. | [] |
NCT04085328 | 10.6 | Clinical Study Termination | 10.6 Clinical Study Termination The Study Sponsor reserves the right to close the investigational site or terminate the study in its entirety at any time. If the clinical study is prematurely terminated or suspended by the Study Sponsor: - The Study Sponsor must: - o Immediately notify the Investigator(s) and subsequen... | [
"e The Investigator must:"
] |
NCT04085328 | 10.6.1 | Follow-up of subjects after study participation has ended | 10.6.1 Follow-up of subjects after study participation has ended Following this study, the subject will return to their eye care professional for their routine eye care. | [] |
NCT04085328 | 11 | ADVERSE EVENTS AND DEVICE DEFICIENCIES | 11 ADVERSE EVENTS AND DEVICE DEFICIENCIES | [] |
NCT04085328 | 11.1 | General Information | 11.1 General Information An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test article). Refer to the Glossary of Terms and figur... | [
"Serious Adverse Events",
"Significant Non-Serious Adverse Events",
"Device Deficiencies"
] |
NCT04085328 | 11.2 | Monitoring for Adverse Events | 11.2 Monitoring for Adverse Events At each visit, after the subject has had the opportunity to spontaneously mention any problems, the Investigator should inquire about AEs by asking the standard questions: - "Have you had any health problems since your last study visit?" - "Have there been any changes in the medicines... | [] |
NCT04085328 | 11.3 | Procedures for Recording and Reporting | 11.3 Procedures for Recording and Reporting AEs are collected from the time of informed consent. Any pre-existing medical conditions or signs/symptoms present in a subject prior to the start of the study (ie, before informed consent is signed) are not considered AEs in the study and should be recorded in the Medical Hi... | [
"Intensity and Causality Assessments",
"Intensity (Severity)",
"Causality"
] |
NCT04085328 | 11.4 | Return product analysis | 11.4 Return product analysis Investigational product associated with device deficiencies and/or product related AEs [ie, ADE or SADE] will be returned for investigation as detailed in the MOP. Document: Version: Page 67 of 78 Status: Effective TDOC-0055758 5.0; Most-Recent; Effective; CURRENT Protocol - Clinical 16-Jan... | [] |
NCT04085328 | 11.5 | Unmasking of the Study Treatment | 11.5 Unmasking of the Study Treatment Masked information on the identity of the assigned medical device should not be disclosed during the study. If the treatment code needs to be broken in the interest of subject safety, the Investigator is encouraged to contact an appropriate Study Sponsor representative prior to unm... | [] |
NCT04085328 | 11.6 | Follow-Up of Subjects with Adverse Events | 11.6 Follow-Up of Subjects with Adverse Events The Investigator is responsible for adequate and safe medical care of subjects during the study and for ensuring that appropriate medical care and relevant follow-up procedures are maintained after the study. The Investigator should provide the Study Sponsor with any new s... | [] |
NCT04085328 | 11.7 | Pregnancy in the Clinical Study | 11.7 Pregnancy in the Clinical Study Pregnancy is not reportable as an AE; however, complications may be reportable and will be decided on a case-by-case basis. Should a woman become pregnant during study participation, the pregnancy will be documented on the Medical History eCRF. Document: Version: Page 68 of 78 Statu... | [] |
NCT04085328 | 12 | ANALYSIS PLAN | 12 ANALYSIS PLAN Any deviations to the analysis plan will be updated during the course of the study as part of a protocol amendment or will be detailed in the clinical study report. All analyses will be conducted according to the applicable statistical analysis plan. | [] |
NCT04085328 | 12.1 | Subject Evaluability | 12.1 Subject Evaluability Final subject evaluability must be determined prior to breaking the code for masked treatment (lens) assignment and locking the database, based upon the Deviations and Evaluability Plan. | [] |
NCT04085328 | 12.2 | Analysis Sets | 12.2 Analysis Sets Five analysis sets will be defined: - a) All Enrolled all subjects signing the informed consent form - b) Enrolled Dispensed subjects/eyes from All Enrolled that have been exposed to study lenses - c) Enrolled Not Dispensed subjects/eyes from All Enrolled that have not been exposed to study lenses - ... | [] |
NCT04085328 | 12.3 | Demographic and Baseline Characteristics | 12.3 Demographic and Baseline Characteristics Demographic information, recent lens-wearing experience (including wear modality and wear success), and habitual lens information will be presented by lens group and overall for the All Enrolled analysis set. Baseline data will be summarized by lens group, for Completed and... | [] |
NCT04085328 | 12.4 | Effectiveness Analyses | 12.4 Effectiveness Analyses For the primary endpoint , separate summaries will be prepared, when applicable, for the Completed and the Discontinued analysis sets as follows: - Completed Control (eyes/subjects) - Completed Test (eyes/subjects) Document: Version: Page 69 of 78 Status: Effective TDOC-0055758 5.0; Most-Rec... | [] |
NCT04085328 | 12.4.1 | Analysis of Primary Effectiveness Endpoint(s) | 12.4.1 Analysis of Primary Effectiveness Endpoint(s) The primary effectiveness endpoint is distance VA with study lenses, collected in Snellen, for each eye. Conversion will be made to the logMAR scale. | [] |
NCT04085328 | 12.4.1.1 | Statistical Hypotheses | 12.4.1.1 Statistical Hypotheses No hypothesis testing on the primary effectiveness endpoint is planned. | [] |
NCT04085328 | 12.4.1.2 | Analysis Methods | 12.4.1.2 Analysis Methods | Summary statistics will be provided. | | |--------------------------------------|--| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Document: Version: Page 70 of 78 Status: Effective TDOC-0055758 5.0; Most-Recent; Effective; CURRENT Protocol - Clinical 16... | [] |
NCT04085328 | 12.6 | Safety Analyses | 12.6 Safety Analyses All AEs occurring from the time a subject signs informed consent to study exit will be accounted for in the reporting. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. Descriptive summaries (counts and percentages) and listings will be presented. Indivi... | [] |
NCT04085328 | 12.6.1 | Analysis of Primary Safety Endpoint(s) | 12.6.1 Analysis of Primary Safety Endpoint(s) The primary safety endpoint is the proportion of ocular serious and significant non-serious ADEs, calculated as the number of eyes reporting at least one treatment-emergent devicerelated ocular serious ADE or treatment-emergent device-related ocular significant non-serious ... | [] |
NCT04085328 | 12.6.1.1 | Statistical Hypotheses | 12.6.1.1 Statistical Hypotheses The null and alternative hypotheses for the primary analysis are: H0: PT- PC≥ 0.05 Ha: PT- PCT and PC denote the proportion of eyes reporting ocular serious and significant non-serious ADEs with and Biofinity contact lenses, respectively. | [] |
NCT04085328 | 12.6.1.2 | Analysis Methods | 12.6.1.2 Analysis Methods A generalized linear model, with a logit link function, accounting for within-subject correlation will be fit. A one-sided 95% upper confidence limit (UCL) will be calculated for the difference in proportions between treatments ( contact lens minus Biofinity contact lens), and the null hypothe... | [] |
NCT04085328 | 12.6.2 | Analysis of Other Safety Endpoints | 12.6.2 Analysis of Other Safety Endpoints Other safety endpoints include: - AE (non-serious, non-significant) - Biomicroscopy findings - Device deficiencies | [] |
NCT04085328 | 12.6.2.1 | Statistical Hypotheses | 12.6.2.1 Statistical Hypotheses No hypothesis testing on the other safety endpoints is planned. | [] |
NCT04085328 | 12.6.2.2 | Analysis Methods | 12.6.2.2 Analysis Methods Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms, for Completed and Discontinued analysis sets. A listing containing details of the AEs will also be provided. Each biomicroscopy paramet... | [] |
NCT04085328 | 12.7 | Interim Analyses and Reporting | 12.7 Interim Analyses and Reporting There are no plans to conduct an interim analysis and no criteria by which the study would be terminated early based upon statistical determination. | [] |
NCT04085328 | 12.8 | Sample Size Justification | 12.8 Sample Size Justification   Taking into consideration the exposure duration of 12 months, approximately 568 subjects will be randomized (284 test and 284 control) to compensate for approximately 25% drop-out rate. | [] |
NCT04085328 | 13 | DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS | 13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS | [] |
NCT04085328 | 13.1 | Subject Confidentiality | 13.1 Subject Confidentiality The Investigator must ensure that the subject's anonymity is maintained throughout the course of the study. In particular, the Investigator must keep an enrollment log with Document: Version: Page 73 of 78 Status: Effective TDOC-0055758 5.0; Most-Recent; Effective; CURRENT Protocol - Clinic... | [] |
NCT04085328 | 13.2 | Completion of Source Documents and Case Report Forms | 13.2 Completion of Source Documents and Case Report Forms The nature and location of all source documents will be identified to ensure that original data required to complete the CRFs exist and are accessible for verification by the site monitor, and all discrepancies shall be appropriately documented via the query res... | [] |
NCT04085328 | 13.3 | Data Review and Clarifications | 13.3 Data Review and Clarifications A review of CRF data to the subject's source data will be completed by the site monitor to ensure completeness and accuracy. After the CRFs have been completed, additional data clarifications and/or additions may be needed as a result of the data cleaning process. Data clarifications... | [] |
NCT04085328 | 13.4 | Sponsor and Monitoring Responsibilities | 13.4 Sponsor and Monitoring Responsibilities The Study Sponsor will designate a monitor to conduct the appropriate site visits at the appropriate intervals according to the study monitoring plan. The clinical investigation will be monitored to ensure that the rights and well-being of the subjects are protected, the rep... | [] |
NCT04085328 | 13.5 | Regulatory Documentation and Records Retention | 13.5 Regulatory Documentation and Records Retention The Investigator is required to maintain up-to-date, complete regulatory documentation as indicated by the Study Sponsor and the Investigator's files will be reviewed as part of the ongoing study monitoring. Financial information is to be kept separately. Additionally... | [] |
NCT04085328 | 13.6 | Quality Assurance and Quality Control | 13.6 Quality Assurance and Quality Control The Study Sponsor will secure agreement from all involved parties to ensure direct access to all study related sites, source data and documents, and reports for the purpose of monitoring and auditing by the Study Sponsor, and inspection by domestic and foreign regulatory autho... | [] |
NCT04085328 | 14 | ETHICS | 14 ETHICS This clinical study must be conducted in accordance with the ethical principles contained within: - The Declaration of Helsinki, and in compliance with the ICH E6 GCP Consolidated Guideline, ISO 14155:2011, and the applicable US FDA 21 CFR Regulations. - SOPs of the Study Sponsor and contract research organiz... | [] |
NCT04085328 | 15 | REFERENCES | 15 REFERENCES | [] |
NCT04085328 | 15.1 | References applicable for all clinical studies | 15.1 References applicable for all clinical studies - ISO 11980:2012 Ophthalmic optics Contact lenses and contact lens care products Guidance for clinical investigations - ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice | [] |
NCT04085328 | 15.1.1 | US references applicable for clinical studies | 15.1.1 US references applicable for clinical studies - 21 CFR Part 11 Electronic Records; Electronic Signatures - 21 CFR Part 50 Protection of Human Subjects - 21 CFR Part 56 Institutional Review Boards - 21 CFR Part 812 Investigational Device Exemptions - 21 CFR Part 54 Financial Disclosure by Clinical Investigators -... | [] |
NCT04091061 | A | PHASE 1, NONRANDOMIZED, OPENLABEL, SINGLEDOSE, PARALLELCOHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF06865571 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT | A PHASE 1, NONRANDOMIZED, OPENLABEL, SINGLEDOSE, PARALLELCOHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF06865571 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT Investigational Product Number PF-06865571 Investigational Product Name: Not Applicable... | [
"Protocol Amendment Summary of Changes Table",
"1.PROTOCOL SUMMARY",
"1.1.Synopsis",
"1.2.Schema",
"1.3.Schedule of Activities(SoA)",
"2.INTRODUCTION",
"2.1.Study Rationale",
"2.2.Background",
"2.2.3.Clinical Overview",
"2.3.Benefit/Risk Assessment",
"3.OBJECTIVES AND ENDPOINTS",
"4.STUDY DESI... |
NCT04102098 | 1 | BACKGROUND | 1. BACKGROUND | [] |
NCT04102098 | 1.1 | BACKGROUND ON HEPATOCELLULAR CARCINOMA | 1.1 BACKGROUND ON HEPATOCELLULAR CARCINOMA | [] |
NCT04102098 | 1.1.1 | Epidemiology and Disease Burden | 1.1.1 Epidemiology and Disease Burden Liver cancer is the fifth most common cancer, accounting for 7% of all cancers, and the second most frequent cause of cancer-related death globally, with 854,000 new cases and 810,000 deaths per year. Hepatocellular carcinoma (HCC) represents approximately 90% of primary liver canc... | [] |
NCT04102098 | 1.1.2 | Unmet Need in Patients following Resection or Ablation | 1.1.2 Unmet Need in Patients following Resection or Ablation There are several potentially curative approaches to the treatment of HCC, including surgical resection and ablation. Liver resection provides an opportunity for long-term, cancer-free survival and represents the primary curative treatment option for patients... | [] |
NCT04102098 | 1.2 | ADJUVANT TREATMENT FOR HEPATOCELLULAR CARCINOMA | 1.2 ADJUVANT TREATMENT FOR HEPATOCELLULAR CARCINOMA Most treatment guidelines do not recommend adjuvant treatment after resection or ablation for HCC because to date no adjuvant treatment has been proven effective in randomized studies (EASL 2018; Heimbach et al. 2018). Strategies tested in the adjuvant setting have in... | [] |
NCT04102098 | 1.3 | BACKGROUND ON ATEZOLIZUMAB | 1.3 BACKGROUND ON ATEZOLIZUMAB Atezolizumab is a humanized IgG1 monoclonal antibody that targets PD-L1 and inhibits the interaction between PD-L1 and its receptors, PD-1 and B7-1 (also known as CD80), both of which function as inhibitory receptors expressed on T cells. Therapeutic blockade of PD-L1 binding by atezolizu... | [] |
NCT04102098 | 1.4 | BACKGROUND ON BEVACIZUMAB | 1.4 BACKGROUND ON BEVACIZUMAB Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in in vitro and in vivo assay systems. Bevacizumab was first granted marketing approval in the United States on 26 February 20... | [] |
NCT04102098 | 1.5 | CLINICAL STUDIES OF ATEZOLIZUMAB PLUS BEVACIZUMAB IN PATIENTS WITH HEPATOCELLULAR CARCINOMA | 1.5 CLINICAL STUDIES OF ATEZOLIZUMAB PLUS BEVACIZUMAB IN PATIENTS WITH HEPATOCELLULAR CARCINOMA The efficacy and safety of atezolizumab plus bevacizumab combination therapy as first-line treatment of non-resectable or metastatic HCC is currently being assessed in two studies: GO30140 and YO40245 (IMbrave150). | [] |
NCT04102098 | 1.5.1 | Study GO30140 | 1.5.1 Study GO30140 Study GO30140 is a Phase Ib, multicenter, open-label study of atezolizumab in combination with bevacizumab and/or chemotherapy as first-line therapy in patients with various metastatic cancers (Lee et al. 2020). Arms A and F of Study GO30140 were specific to unresectable or advanced HCC. Arm A was d... | [
"Arm A",
"Arm F"
] |
NCT04102098 | 1.5.2 | Study YO40245 | 1.5.2 Study YO40245 Study YO40245 (IMbrave150) is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sorafenib in patients with advanced or metastatic HCC who have received no prior systemic treatment (Cheng et al. 2019; Finn et al... | [] |
NCT04102098 | 1.6 | STUDY RATIONALE AND BENEFITRISK ASSESSMENT | 1.6 STUDY RATIONALE AND BENEFITRISK ASSESSMENT Multiple lines of evidence suggest that immune-based therapies may be beneficial in patients with resected or ablated HCC. The PD-L1/PD-1 inhibitors have demonstrated clinical benefit across a wide range of cancer types, including HCC. Although the majority of studies with... | [
"Covid-19 Benefit–Risk Assessment"
] |
NCT04102098 | 2 | OBJECTIVES AND ENDPOINTS | 2. OBJECTIVES AND ENDPOINTS This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in patients with completely resected or ablated HCC who are at high risk for disease recurrence. Patients randomized to the active surveillance arm who re... | [] |
NCT04102098 | 3 | STUDY DESIGN | 3. STUDY DESIGN | [] |
NCT04102098 | 3.1 | OVERVIEW OF STUDY DESIGN | 3.1 OVERVIEW OF STUDY DESIGN This is a Phase III, global, multicenter, open-label, two-arm, randomized study designed to evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in patients with completely resected or ablated HCC who are at high risk for ... | [
"Treatment with Atezolizumab plus Bevacizumab following Recurrence for Patients in Arm B"
] |
NCT04102098 | 3.1.1 | Independent Data Monitoring Committee | 3.1.1 Independent Data Monitoring Committee An independent Data Monitoring Committee (iDMC) will evaluate safety and efficacy data during the study. Sponsor affiliates will be excluded from iDMC membership. The iDMC will follow a charter that outlines the iDMC roles and responsibilities. Unblinded safety data will be r... | [] |
NCT04102098 | 3.1.2 | Independent Review Facility | 3.1.2 Independent Review Facility An IRF will be used to enable centralized, independent reviews of images and other clinical data (e.g., histopathology, tumor markers etc.) used for assessment of HCC recurrence. The IRF reviews will be performed prior to the pre-specified efficacy analyses. The IRF membership and proc... | [] |
NCT04102098 | 3.2 | END OF STUDY AND LENGTH OF STUDY | 3.2 END OF STUDY AND LENGTH OF STUDY The end of this study is defined as the date when approximately 319 OS events have been observed for the final analysis of OS in the ITT population. In addition, the Sponsor may decide to terminate the study at any time. The total length of the study, from randomization of the first... | [] |
NCT04102098 | 3.3 | DURATION OF PARTICIPATION | 3.3 DURATION OF PARTICIPATION The total duration of study participation for each individual is expected to range from 1 day up to approximately 91 months. | [] |
NCT04102098 | 3.4 | RATIONALE FOR STUDY DESIGN | 3.4 RATIONALE FOR STUDY DESIGN | [] |
NCT04102098 | 3.4.1 | Rationale for Atezolizumab Dose and Schedule | 3.4.1 Rationale for Atezolizumab Dose and Schedule Atezolizumab will be administered at a fixed dose of 1200 mg Q3W (1200 mg on Day 1 of each 21-day cycle), which is an approved dosage for atezolizumab, as outlined in the prescribing information). Anti-tumor activity has been observed across doses ranging from 1 mg/kg ... | [] |
NCT04102098 | 3.4.2 | Rationale for Bevacizumab Dose and Schedule | 3.4.2 Rationale for Bevacizumab Dose and Schedule Bevacizumab will be administered at a dose of 15 mg/kg Q3W (15 mg/kg on Day 1 of each 21-day cycle), which is the approved dosage for bevacizumab (Avastin® U.S. Package Insert). This dose schedule aligns with the atezolizumab dose schedule highlighted above and is the d... | [] |
NCT04102098 | 3.4.3 | Rationale for Patient Population | 3.4.3 Rationale for Patient Population The target population has been chosen to address patients with HCC who have a high risk of disease recurrence following curative resection or ablation. The risk of HCC recurrence after curative intervention is primarily related to tumor characteristics at the time of surgery or ab... | [] |
NCT04102098 | 3.4.4 | Rationale for the Active Surveillance Control Arm (Arm B) | 3.4.4 Rationale for the Active Surveillance Control Arm (Arm B) There is no standard adjuvant treatment after resection or ablation for HCC. For the most part, treatment guidelines do not recommend adjuvant therapy for HCC because to date no treatment has been proven effective in randomized studies after potentially cu... | [] |
NCT04102098 | 3.4.5 | Rationale for Crossover from Active Surveillance to Treatment with Atezolizumab plus Bevacizumab | 3.4.5 Rationale for Crossover from Active Surveillance to Treatment with Atezolizumab plus Bevacizumab Patients randomized to Arm B will be offered the chance to cross over to treatment with atezolizumab plus bevacizumab upon documented IRF-confirmed recurrence if deemed clinically appropriate by the investigator, to b... | [] |
NCT04102098 | 3.4.6 | Rationale for Recurrence-Free Survival as Primary Endpoint | 3.4.6 Rationale for Recurrence-Free Survival as Primary Endpoint Treatment benefit will be measured in this trial using RFS as the primary efficacy endpoint. The RFS is an endpoint that quantifies clinically meaningful benefit to patients with HCC and is recommended by HCC experts as a primary endpoint for adjuvant stu... | [] |
NCT04102098 | 3.4.7 | Rationale for Choice of Randomization Stratification Factors | 3.4.7 Rationale for Choice of Randomization Stratification Factors To balance the clinical risk factors between the two study arms, randomization will be stratified using a permuted-block randomization scheme. The stratification factors are as follows: - Geographic region - – Asia Pacific excluding Japan - – Rest of Wo... | [
"Geographic Region",
"High Risk Features/Curative Procedure"
] |
NCT04102098 | 3.4.8 | Rationale for Biomarker Assessments | 3.4.8 Rationale for Biomarker Assessments The PD-L1 expression in tumor tissues has been shown to be correlated with the clinical benefits from antiPD-1 and antiPD-L1 therapy across many tumor indications (Topalian et al. 2012; Herbst et al. 2014, 2016; Borghaei et al. 2015; Fehrenbacher et al. 2016; Rosenberg et al. 2... | [] |
NCT04102098 | 3.4.9 | Rationale for Patient-Reported Outcomes | 3.4.9 Rationale for Patient-Reported Outcomes Early stage HCC is largely asymptomatic, with the majority of patients exhibiting no disease-specific, discernable symptoms. Instead, it is the impact of treatment and the associated burden, rather than disease burden, that defines the patient experience. Therefore, in this... | [] |
NCT04102098 | 4 | MATERIALS AND METHODS | 4. MATERIALS AND METHODS | [] |
NCT04102098 | 4.1 | PATIENTS | 4.1 PATIENTS Approximately 662 patients with completely resected or ablated HCC who are at high risk for disease recurrence will be enrolled during the global enrollment phase of this study (see Table 4). After completion of the global enrollment phase, additional patients may be enrolled in China in an extended China ... | [] |
NCT04102098 | 4.1.1 | Inclusion Criteria | 4.1.1 Inclusion Criteria Patients must meet the following criteria for study entry: - Signed Informed Consent Form - Age 18 years at time of signing Informed Consent Form - Ability to comply with the study protocol - Participants with a first diagnosis of HCC who have undergone either a curative resection or ablation (... | [] |
NCT04102098 | 4.1.1.1 | Additional Inclusion Criteria for Crossover for Patients in Arm B | 4.1.1.1 Additional Inclusion Criteria for Crossover for Patients in Arm B Patients randomized to Arm B must meet the following criteria to qualify for crossover to treatment with atezolizumab plus bevacizumab: - Patient meets all other eligibility criteria in Sections 4.1.1 and 4.1.2. However the following criteria are... | [] |
NCT04102098 | 4.1.2 | Exclusion Criteria | 4.1.2 Exclusion Criteria Patients who meet any of the following criteria will be excluded from the study: - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC - Evidence of residual, recurrent, or metastatic disease at randomization - Clinically significant ascites - History of hepatic enceph... | [] |
NCT04102098 | 4.2 | METHOD OF TREATMENT ASSIGNMENT AND BLINDING | 4.2 METHOD OF TREATMENT ASSIGNMENT AND BLINDING This is a randomized, open-label study. After written informed consent has been obtained, all screening procedures and assessments have been completed, and eligibility has been established for a patient, the study site will obtain the patient's identification number and t... | [] |
NCT04102098 | 4.3 | STUDY TREATMENT AND OTHER TREATMENTS RELEVANT TO THE STUDY DESIGN | 4.3 STUDY TREATMENT AND OTHER TREATMENTS RELEVANT TO THE STUDY DESIGN The investigational medicinal products (IMPs) for this study are atezolizumab and bevacizumab. Appendix 14 identifies all IMPs. | [] |
NCT04102098 | 4.3.1 | Study Treatment Formulation, Packaging, and Handling | 4.3.1 Study Treatment Formulation, Packaging, and Handling | [] |
NCT04102098 | 4.3.1.1 | Atezolizumab | 4.3.1.1 Atezolizumab The atezolizumab drug product will be supplied by the Sponsor as a sterile liquid in a single-use, 20-mL glass vial. The vial contains approximately 20 mL (1200 mg) of atezolizumab solution. For information on the formulation and handling of atezolizumab, see the pharmacy manual and the Atezolizuma... | [] |
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