protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT03671434 | 10.0 | Data and Safety Monitoring Plan | 10.0 Data and Safety Monitoring Plan This section is required when research involves more than Minimal Risk to subjects.As defined in "SOP: Definitions (HRP-001)", available in the Library in CATS IRB (http://irb.psu.edu), Minimal Risk is defined as the probability and magnitude of harm or discomfort anticipated in the... | [] |
NCT03671434 | 10.1 | Periodic evaluation of data | 10.1 Periodic evaluation of data Describe the plan to periodically evaluate the data collected regarding both harms and benefits to determine whether subjects remain safe. N/A. This study involves Minimal Risk to participants. | [] |
NCT03671434 | 10.2 | Data that are reviewed | 10.2 Data that are reviewed Describe the data that are reviewed, including safety data, untoward events, and efficacy data. N/A. This study involves Minimal Risk to participants. | [] |
NCT03671434 | 10.3 | Method of collection of safety information | 10.3 Method of collection of safety information Describe the method by which the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls and with subjects). N/A. This study involves Minimal Risk to participants. | [] |
NCT03671434 | 10.4 | Frequency of data collection | 10.4 Frequency of data collection Describe the frequency of data collection, including when safety data collection starts. N/A. This study involves Minimal Risk to participants. | [] |
NCT03671434 | 10.5 | Individuals reviewing the data | 10.5 Individuals reviewing the data Identify the individuals who will review the data. The plan might include establishing a data and safety monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the sponsor. N/A. This study involves Minimal Risk to participants. | [] |
NCT03671434 | 10.6 | Frequency of review of cumulative data | 10.6 Frequency of review of cumulative data Describe the frequency or periodicity of review of cumulative data. N/A. This study involves Minimal Risk to participants. | [] |
NCT03671434 | 10.7 | Statistical tests | 10.7 Statistical tests Describe the statistical tests for analyzing the safety data to determine whether harms are occurring. N/A. This study involves Minimal Risk to participants. | [] |
NCT03671434 | 10.8 | Suspension of research | 10.8 Suspension of research Describe any conditions that trigger an immediate suspension of research. N/A. This study involves Minimal Risk to participants. | [] |
NCT03671434 | 11.0 | Risks | 11.0 Risks List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects related the subjects' participation in the research. For each potential risk, describe the probability, magnitude, duration, and reversibility. Consider all types of risk including physical, psychological, social, ... | [] |
NCT03671434 | 12.0 | Potential Benefits to Subjects and Others | 12.0 Potential Benefits to Subjects and Others | [] |
NCT03671434 | 12.1 | Potential Benefits to Subjects | 12.1 Potential Benefits to Subjects Describe the potential benefits that individual subjects may experience from taking part in the research. If there is no direct benefit to subjects, indicate as such. Compensation is not considered a benefit. Compensation should be addressed in section 14.0. There are no direct benef... | [] |
NCT03671434 | 12.2 | Potential Benefits to Others | 12.2 Potential Benefits to Others Include benefits to society or others. This work has the potential to strengthen efforts to improve the use of research evidence in policymaking processes, as well as to inform how researchers are trained and prepared for policy engagement. Moreover, insights gleaned will inform the ac... | [] |
NCT03671434 | 13.0 | Sharing Results with Subjects | 13.0 Sharing Results with Subjects Describe whether results (study results or individual subject results, such as results of investigational diagnostic tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the subject's primary care physicians) and if so, describe how it will be sh... | [] |
NCT03671434 | 14.0 | Subject Stipend (Compensation) and/or Travel Reimbursements | 14.0 Subject Stipend (Compensation) and/or Travel Reimbursements Describe the amount and timing of any subject stipend/payment or travel reimbursement here. If there is no subject stipend/payment or travel reimbursement, indicate as not applicable. If course credit or extra credit is offered to subjects, describe the a... | [] |
NCT03671434 | 15.0 | Economic Burden to Subjects | 15.0 Economic Burden to Subjects | [] |
NCT03671434 | 15.1 | Costs | 15.1 Costs Describe any costs that subjects may be responsible for because of participation in the research. Participants will not be affected by direct costs for participation in this study; however, indirect costs include participants' time for participation. Participation in the survey is expected to require approxi... | [] |
NCT03671434 | 15.2 | Compensation for research-related injury | 15.2 Compensation for research-related injury If the research involves more than Minimal Risk to subjects, describe the available compensation in the event of research related injury. If there is no sponsor agreement that addresses compensation for medical care for research subjects with a research-related injury, incl... | [] |
NCT03671434 | 16.0 | Resources Available | 16.0 Resources Available | [] |
NCT03671434 | 16.1 | Facilities and locations | 16.1 Facilities and locations Identify and describe the facilities, sites and locations where recruitment and study procedures will be performed. If research will be conducted outside the United States, describe site-specific regulations or customs affecting the research, and describe the process for obtaining local et... | [] |
NCT03671434 | 16.2 | Feasibility of recruiting the required number of subjects | 16.2 Feasibility of recruiting the required number of subjects Indicate the number of potential subjects to which the study team has access. Indicate the percentage of those potential subjects needed for recruitment. It is anticipated that around 300 researchers will be recruited for the RPC. We believe that at least ¾... | [] |
NCT03671434 | 16.3 | PI Time devoted to conducting the research | 16.3 PI Time devoted to conducting the research Describe how the PI will ensure that a sufficient amount of time will be devoted to conducting and completing the research. Please consider outside responsibilities as well as other on-going research for which the PI is responsible. The Primary Investigator, Max Crowley, ... | [] |
NCT03671434 | 16.4 | Availability of medical or psychological resources | 16.4 Availability of medical or psychological resources Describe the availability of medical or psychological resources that subject might need as a result of their participation in the study, if applicable. This study involves Minimal Risk for participants. | [] |
NCT03671434 | 16.5 | Process for informing Study Team | 16.5 Process for informing Study Team Describe the training plans to ensure members of the research team are informed about the protocol and their duties, if applicable. All research team members must complete the mandatory CITI training in human subjects research. The IRB protocol will be reviewed by all team members,... | [] |
NCT03671434 | 17.0 | Other Approvals | 17.0 Other Approvals | [] |
NCT03671434 | 17.1 | Other Approvals from External Entities | 17.1 Other Approvals from External Entities Describe any approvals that will be obtained prior to commencing the research (e.g., from cooperating institutions, community leaders, schools, external sites, funding agencies). N/A | [] |
NCT03671434 | 17.2 | Internal PSU Committee Approvals | 17.2 Internal PSU Committee Approvals
Check all that apply: Anatomic Pathology – Hershey only – Research involves the collection of tissues or use of pathologic specimens. Upload a copy of HRP-902 - Human Tissue For Research Form on the "Supporting Documents"page in CATS IRB. This form is available in the CATS IRB Lib... | [
"Check all that apply:"
] |
NCT03671434 | 18.0 | Multi-Site Research | 18.0 Multi-Site Research If this is a multi-site study (i.e.,the study will be conducted at other institutions each with its own principal investigator) and you are the lead investigator, describe the processes to ensure communication among sites in the sections below. | [] |
NCT03671434 | 18.1 | Communication Plans | 18.1 Communication Plans Describe the plan for regular communication between the overall study director and the other sites to ensure that all sites have the most current version of the protocol, consent document, etc. Describe the process to ensure all modifications have been communicated to sites. Describe the proces... | [] |
NCT03671434 | 18.2 | Data Submission and Security Plan | 18.2 Data Submission and Security Plan Describe the process and schedule for data submission and provide the data security plan for data collected from other sites. Describe the process to ensure all engaged participating sites will safeguard data as required by local information security policies. N/A | [] |
NCT03671434 | 18.3 | Subject Enrollment | 18.3 Subject Enrollment Describe the procedures for coordination of subject enrollment and randomization for the overall project. N/A | [] |
NCT03671434 | 18.4 | Reporting of Adverse Events and New Information | 18.4 Reporting of Adverse Events and New Information Describe how adverse events and other information will be reported from the clinical sites to the overall study director. Provide the timeframe for this reporting. N/A | [] |
NCT03671434 | 18.5 | Audit and Monitoring Plans | 18.5 Audit and Monitoring Plans Describe the process to ensure all local site investigators conduct the study appropriately. Describe any on-site auditing and monitoring plans for the study. N/A | [] |
NCT03671434 | 19.0 | Adverse Event Reporting | 19.0 Adverse Event Reporting | [] |
NCT03671434 | 19.1 | Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB | 19.1 Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE: In accordance with applicable policies of The Pennsylvania State University Institutional Review Board (IRB), the investigator will repor... | [] |
NCT03671434 | 20.0 | Study Monitoring, Auditing and Inspecting | 20.0 Study Monitoring, Auditing and Inspecting | [] |
NCT03671434 | 20.1 | Auditing and Inspecting | 20.1 Auditing and Inspecting By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE: The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality assurance program office(s), IRB, the sponsor, and government regulatory bodies, of al... | [] |
NCT03671434 | 21.0 | Future Undetermined Research: Data and Specimen Banking | 21.0 Future Undetermined Research: Data and Specimen Banking If this study is collecting identifiable data and/or specimens that will be banked for future undetermined research, please describe this process in the sections below. This information should not conflict with information provided in section 9.1.1 regarding ... | [] |
NCT03671434 | 21.1 | Data and/or specimens being stored | 21.1 Data and/or specimens being stored Identify what data and/or specimens will be stored and the data associated with each specimen. All data will be handled in accordance with the consent procedures and IRB protocol. Identifiers will be stripped from the data files for archival storage. Identifying information will ... | [] |
NCT03671434 | 21.2 | Location of storage | 21.2 Location of storage Identify the location where the data and/or specimens will be stored. Archival data will be stored on SharePoint, PSU's secure cloud file transfer server. | [] |
NCT03671434 | 21.3 | Duration of storage | 21.3 Duration of storage Identify how long the data and/or specimens will be stored. De-identified study data will be archived indefinitely. Identifying info will be destroyed within three years of the end of the project. | [] |
NCT03671434 | 21.4 | Access to data and/or specimens | 21.4 Access to data and/or specimens Identify who will have access to the data and/or specimens. Only the research team will have access to archival data. | [] |
NCT03671434 | 21.5 | Procedures to release data or specimens | 21.5 Procedures to release data or specimens Describe the procedures to release the data and/or specimens, including: the process to request a release, approvals required for release, who can obtain data and/or specimens, and the data to be provided with the specimens. Identifying information will not be released. Only... | [] |
NCT03671434 | 21.6 | Process for returning results | 21.6 Process for returning results Describe the process for returning results about the use of the data and/or specimens. N/A | [] |
NCT03671434 | 22.0 | References | 22.0 References List relevant references in the literature which highlight methods, controversies, and study outcomes. Crowley, M.D. Scott, J.T. & Fishbein, D. (2017). Translating prevention research for evidence-based policymaking: Results from the Research-to-Policy Collaboration pilot. Prevention Science. - Dumont K... | [] |
NCT03679767 | 1 | PROTOCOL SUMMARY | 1. PROTOCOL SUMMARY Protocol Title: A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203) Protocol Number: INCMGA 0012-203 Objectives and Endpoints: [Table 1](#page-11-1) presents the primary objective and endpoint. Table 1: Primary Objective and Endpoint | Objective | ... | [
"Overall Design:",
"Treatment Groups and Duration:"
] |
NCT03679767 | 2 | INTRODUCTION | 2. INTRODUCTION | [] |
NCT03679767 | 2.1 | Background | 2.1. Background Immunotherapy has had a major impact on the treatment of advanced cancer. Monoclonal antibodies against the immune checkpoints such as cytotoxic T-lymphocyte antigen-4 (CTLA-4) and PD-1 and its ligand, PD-L1, have been approved for many indications [\(Keytruda® 2018,](#page-63-0) [Opdivo® 2018\)](#page-... | [] |
NCT03679767 | 2.1.1 | INCMGA00012 | 2.1.1. INCMGA00012 INCMGA00012 is a humanized, hinge-stabilized, IgG4κ monoclonal antibody that recognizes human PD-1. INCMGA00012 contains a human IgG4 Fc domain to limit effector function while retaining neonatal Fc receptor binding to extend circulating half-life. INCMGA00012 is designed to target PD-1–expressing ce... | [] |
NCT03679767 | 2.2 | Rationale for Study Design | 2.2. Rationale for Study Design The study is an open-label, nonrandomized, multi-cohort trial that is designed to provide proof of concept for INCMGA00012 in key indications where other PD-1 inhibitors have already shown efficacy. Clinical studies are an important mechanism for providing access to promising therapies w... | [] |
NCT03679767 | 2.2.1 | Population | 2.2.1. Population Overall response to PD-1 directed therapy is an important early indication of whether a new immunotherapy is likely to prove useful in the clinic. Since ORRs of 30% to 40% have been shown with other PD-1 inhibitors against the indications to be studied (see [Table 5\)](#page-18-1), this provides a use... | [] |
NCT03679767 | 2.2.2 | Dose and Schedule | 2.2.2. Dose and Schedule Fixed doses of therapeutics have several advantages over weight-based doses, including convenience of preparation and administration, reduced errors in preparation calculation, and minimization of drug waste. Body size–based doses and fixed doses of mAbs have been evaluated, and the 2 approache... | [] |
NCT03679767 | 2.3 | Benefit/Risk Assessment | 2.3. Benefit/Risk Assessment Treatment directed at the PD-1/PD-L1 axis is a promising approach to the diseases under study. Monoclonal antibodies against PD-1 have shown benefit for these and other indications and safety of these agents has been well characterized [\(Keytruda 2018,](#page-63-0) [Opdivo 2018\)](#page-63... | [] |
NCT03679767 | 3 | OBJECTIVES AND ENDPOINTS | 3. OBJECTIVES AND ENDPOINTS [Table 6](#page-20-1) presents the objectives and endpoints. Table 6: Objectives and Endpoints | Objectives | Endpoints | |------------------------------------------------------------------------------------------|------------------------------------------------------------------------------... | [] |
NCT03679767 | 4 | STUDY DESIGN | 4. STUDY DESIGN | [] |
NCT03679767 | 4.1 | Overall Design | 4.1. Overall Design This study is a Phase 2, open-label, multicenter study designed to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established. Participants with the following tumor types will be enrolled int... | [] |
NCT03679767 | 4.2 | Overall Study Duration | 4.2. Overall Study Duration The study begins when the first participant signs the ICF. The end of the study is defined as the date of the last visit of the last participant in the study. The study will end when the last participant completes 90 days of safety follow-up for irAEs. No participant will be followed for lon... | [] |
NCT03679767 | 4.3 | Study Termination | 4.3. Study Termination The investigator retains the right to terminate study participation at any time, according to the terms specified in the study contract. The investigator is to notify the IRB/IEC in writing of the study's completion or early termination, send a copy of the notification to the sponsor or sponsor's... | [] |
NCT03679767 | 5 | STUDY POPULATION | 5. STUDY POPULATION Deviations from eligibility criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability, and/or participant safety. Therefore, adherence to the criteria as specified in the Protocol is essential. Prospective approval of Protocol de... | [] |
NCT03679767 | 5.1 | Inclusion Criteria | 5.1. Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: - 1. Ability to comprehend and willingness to sign a written ICF for the study. - 2. Men and women 18 years of age or older (or as applicable per local country requirements). - 3. Confirmed diagnos... | [] |
NCT03679767 | 5.2 | Exclusion Criteria | 5.2. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: - 1. Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug. - 2. Prior treatment with PD-1 or PD-L1 directed therapy (ot... | [] |
NCT03679767 | 5.3 | Lifestyle Considerations | 5.3. Lifestyle Considerations Not applicable. | [] |
NCT03679767 | 5.4 | Screen Failures | 5.4. Screen Failures Screen failures are defined as participants who consent to participate in the clinical study but are not subsequently assigned to study drug. Tests with results that fail eligibility requirements may be repeated during screening. Additionally, a participant who fails screening may repeat the screen... | [] |
NCT03679767 | 5.5 | Replacement of Participants | 5.5. Replacement of Participants Not applicable. | [] |
NCT03679767 | 6 | STUDY TREATMENT | 6. STUDY TREATMENT | [] |
NCT03679767 | 6.1 | Study Treatments Administered | 6.1. Study Treatments Administered [Table 8](#page-27-3) presents the study drug information. Table 8: Study Drug Information | Study drug name: | INCMGA00012 | | |----------------------------------------------------------------------------------------------------|-------------------------------------------------------... | [] |
NCT03679767 | 6.2 | Preparation, Handling, and Accountability | 6.2. Preparation, Handling, and Accountability The investigator or designee must confirm appropriate temperature conditions have been maintained during transit for all study drug received and any discrepancies are reported and resolved before use of the study drug. Only participants enrolled in the study may receive st... | [] |
NCT03679767 | 6.3 | Measures to Minimize Bias: Randomization and Blinding | 6.3. Measures to Minimize Bias: Randomization and Blinding Not applicable. | [] |
NCT03679767 | 6.4 | Study Treatment Compliance | 6.4. Study Treatment Compliance Compliance with all study-related treatments should be emphasized to the participant by the site personnel, and appropriate steps should be taken to optimize compliance during the study. Compliance with study drug will be calculated by the sponsor based on the drug accountability documen... | [] |
NCT03679767 | 6.5 | Dose Modifications | 6.5. Dose Modifications Dose reduction is not allowed. Before the start of each treatment cycle, the participant must meet the treatment continuation criteria (see Section [4.1\)](#page-21-1). Management guidelines for immune-related adverse reactions commonly observed with other PD-1 inhibitors are provided in the fol... | [] |
NCT03679767 | 6.5.1 | Management of Suspected Infusion Reactions | 6.5.1. Management of Suspected Infusion Reactions Infusion or hypersensitivity reactions may be observed with administration of any foreign protein. Premedication with an antipyretic (eg, acetaminophen/paracetamol) and a histamine blocker (eg, diphenhydramine) should be considered for participants who have had previous... | [] |
NCT03679767 | 6.5.2 | Management of Suspected Immune-Related Adverse Events | 6.5.2. Management of Suspected Immune-Related Adverse Events Adverse events of a potential immunologic etiology or irAEs may be defined as an AE of unknown etiology, associated with drug exposure, and consistent with an immune phenomenon. Immune-related AEs may be predicted based on the nature of the compounds, their m... | [] |
NCT03679767 | 6.5.3 | Permanent Discontinuation of Study Drug Due to Toxicity | 6.5.3. Permanent Discontinuation of Study Drug Due to Toxicity The occurrence of unacceptable toxicity not caused by the underlying disease will require that the study treatment be permanently discontinued. Unacceptable toxicity is defined as follows: - Occurrence of an AE that is related to study treatment that, in th... | [] |
NCT03679767 | 6.6 | Concomitant Medications and Procedures | 6.6. Concomitant Medications and Procedures All concomitant medications and treatments (including over-the-counter or prescription medicines, vitamins, vaccines, and/or herbal supplements) must be recorded in the eCRF. Any medication received up to 30 days before the first dose of study drug and 28 days after the last ... | [] |
NCT03679767 | 6.6.1 | Permitted Medications and Procedures | 6.6.1. Permitted Medications and Procedures Recommended supportive measures for specific toxicities are described in Section [6.5.](#page-28-2) Growth factors, bisphosphonates, anticoagulants, and transfusional support will also be permitted per standard institutional practice. Antiretroviral therapy should be continue... | [] |
NCT03679767 | 6.6.2 | Prohibited Medications and Procedures | 6.6.2. Prohibited Medications and Procedures - Other anticancer therapies, including investigational treatments within 21 days before the first administration of study drug, and throughout the treatment period of the study. - Immunosuppression in excess of physiologic maintenance corticosteroid doses (> 10 mg of predni... | [] |
NCT03679767 | 6.7 | Treatment After the End of the Study | 6.7. Treatment After the End of the Study Once a participant has discontinued study treatment, no further treatment will be provided in this study. | [] |
NCT03679767 | 7 | DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT DISCONTINUATION/WITHDRAWAL | 7. DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT DISCONTINUATION/WITHDRAWAL | [] |
NCT03679767 | 7.1 | Discontinuation of Study Drug | 7.1. Discontinuation of Study Drug | [] |
NCT03679767 | 7.1.1 | Reasons for Discontinuation | 7.1.1. Reasons for Discontinuation Participants must be withdrawn from study drug for the following reasons: - Disease progression (see Section [4.1\)](#page-21-1). - Unacceptable toxicity as noted in Section [6.5.3.](#page-34-0) - The participant becomes pregnant. If the female participant is no longer pregnant and me... | [] |
NCT03679767 | 7.1.2 | Discontinuation Procedures | 7.1.2. Discontinuation Procedures In the event that the decision is made to permanently discontinue the study drug, the EOT visit should be conducted. Reasonable efforts should be made to have the participant return for a final safety visit. These visits are described in [Table 3](#page-13-0) and [Table 4.](#page-15-0)... | [
"If a participant is discontinued from study drug:"
] |
NCT03679767 | 7.2 | Participant Withdrawal From the Study | 7.2. Participant Withdrawal From the Study A participant may withdraw from the study at any time at his/her own request or may be withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, or administrative reasons. If the participant withdraws consent for disclosure of future infor... | [] |
NCT03679767 | 7.3 | Lost to Follow-Up | 7.3. Lost to Follow-Up A participant will be considered lost to follow-up and withdrawn from the study if he/she repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. | [] |
NCT03679767 | 8 | STUDY ASSESSMENTS AND PROCEDURES | 8. STUDY ASSESSMENTS AND PROCEDURES | [] |
NCT03679767 | 8.1 | Administrative and General Procedures | 8.1. Administrative and General Procedures | [] |
NCT03679767 | 8.1.1 | Informed Consent Process | 8.1.1. Informed Consent Process - The investigator or his/her representative will explain the nature of the study to the participant or his/her legally authorized representative and answer all questions regarding the study. - − Informed consent must be obtained before any study-related procedures are conducted, unless ... | [] |
NCT03679767 | 8.1.2 | Screening Procedures | 8.1.2. Screening Procedures Screening is the interval between signing the ICF and the day the participant is enrolled in the study (Cycle 1 Day 1). Screening may not exceed 28 days. Assessments that are required to demonstrate eligibility may be performed over the course of 1 or more days during the screening process. ... | [] |
NCT03679767 | 8.1.3 | Interactive Response Technology Procedure | 8.1.3. Interactive Response Technology Procedure Each participant will be identified in the study by a participant ID number, which is a combination of the site ID and participant number. After determining that the participant is eligible for study entry at screening, site staff should contact the IRT to obtain the par... | [] |
NCT03679767 | 8.1.4 | Distribution of Reminder Cards | 8.1.4. Distribution of Reminder Cards Participants will be provided with a reminder card at each visit. The reminder card will indicate the date/time of the next visit and will also inform the participant about visit-specific procedures. Some study procedures may be conducted by phone call, where appropriate, or as per... | [] |
NCT03679767 | 8.1.5 | Demography and Medical History | 8.1.5. Demography and Medical History | [] |
NCT03679767 | 8.1.5.1 | Demographics and General Medical History | 8.1.5.1. Demographics and General Medical History Demographic data and general medical history will be collected at screening by the investigator or qualified designee and will include age, race, ethnicity, medical and surgical history, and current illnesses. | [] |
NCT03679767 | 8.1.5.2 | Disease Characteristics and Treatment History | 8.1.5.2. Disease Characteristics and Treatment History A disease-targeted medical and treatment history will be collected at screening. Details regarding the participant's malignancy under study, including date of diagnosis, initial and current cancer stage, tumor histology, and relevant disease characteristics, and pr... | [] |
NCT03679767 | 8.2 | Efficacy Assessments | 8.2. Efficacy Assessments Objective assessment of disease status will be evaluated according to RECIST v1.1 [\(Eisenhauer et al 2009\)](#page-62-10) and entered into the eCRF. Efficacy assessments of response should be performed according to schedule found in [Table 3.](#page-13-0) Scans should follow calendar days and... | [] |
NCT03679767 | 8.2.1 | Tumor Imaging | 8.2.1. Tumor Imaging Disease assessment and tumor response to study drug will be evaluated according to RECIST v1.1 guidelines [\(Eisenhauer et al 2009\)](#page-62-10) as described in [Appendix B.](#page-66-0) The recommended method for measuring and following tumor burden will be CT scan, which should be performed usi... | [] |
NCT03679767 | 8.2.2 | iRECIST | 8.2.2. iRECIST iRECIST is not used to determine efficacy of INCMGA00012 in this study but may be used for patient management with the decision to treat beyond conventional RECIST progression documented in the study file. Immunotherapeutic agents may produce antitumor effects by potentiating endogenous cancer-specific i... | [] |
NCT03679767 | 8.2.3 | Health Economics | 8.2.3. Health Economics Not applicable. | [] |
NCT03679767 | 8.3 | Safety Assessments | 8.3. Safety Assessments See Section [6.5](#page-28-2) for guidelines regarding the management of relevant laboratory or other safety assessment abnormalities. | [] |
NCT03679767 | 8.3.1 | Adverse Events | 8.3.1. Adverse Events Adverse events will be monitored from the time the participant signs the ICF until at least 28 days after the last dose of study drug. Immune-related AEs will be collected until 90 days after the last dose of study drug. The 90-day visit may be conducted via phone call. Adverse events that begin o... | [] |
NCT03679767 | 8.3.2 | Physical Examinations | 8.3.2. Physical Examinations Physical examinations must be performed by a medically qualified individual, such as a licensed physician, physician's assistant, or an advanced registered nurse practitioner, as local law permits. Abnormalities identified after the first dose of study drug constitute an AE if they are cons... | [] |
NCT03679767 | 8.3.3 | Vital Signs | 8.3.3. Vital Signs Vital sign measurements (to be taken before blood collection for laboratory tests) include blood pressure, weight, pulse, respiratory rate, and body temperature. Blood pressure and pulse will be taken with the participant in the recumbent, semirecumbent, or sitting position after 5 minutes of rest. A... | [] |
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