Trial · NCT02500797
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Achieved a Confirmed Response | Up to 44 months | The number of participants who achieved a confirmed response is defined as the number of patients having a best objective tumor status of complete response (CR) or partial response (PR) lasting at least 4 weeks as determined using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites). |
| Secondary | Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Regardless of Attribution | Up to 4 weeks after completion of study treatment | The number of participants who experienced at least one grade 3 or higher adverse event (AE) regardless of attribution. AEs are graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 beginning April 1, 2018). |
| Secondary | Duration of Response | Time from first response to progression, assessed up to 3 years | Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir). |
| Secondary | 6-Month Clinical Benefit Rate [Initial Cohort] | At 6 months | The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD). |
| Secondary | 6-Month Clinical Benefit Rate [Expansion LPS and UPS/MFH Cohorts Only] | At 6 months | The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD). |
| Secondary | 6-Month Clinical Benefit Rate [Expansion GIST Cohort Only] | At 6 months | The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD). |
| Secondary | Progression-free Survival (PFS) | Time from randomization to first of either disease progression or death from any cause, assessed up to 3 years | Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. (PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir). |
| Secondary | Overall Survival (OS) | Time from randomization to death from any cause, assessed up to 3 years | Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. |
| Other | PD-L1 Expression Assessed Using Immunohistochemistry (IHC) | Up to 3 years | Categorical data analysis and logistic regression will be used to evaluate the associations between PD-L1 expression (by IHC) and clinical outcome (e.g., response, clinical benefit, progression-free survival, and survival). Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints. |
| Other | Change in Selected Biomarkers Measured in Serial Peripheral Blood | Baseline to up to 3 years | Summary statistics will be used to for describing changes across time. The time course of biomarker outcomes will be investigated graphically, by summary plots or individual patient plots. If there is suggestion of meaningful trend, methods such as linear mixed models may be used to characterize the pattern of change over time. Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints. |
| Other | Selected Biomarkers Measured in Tumor Tissue | Up to week 6 | Categorical data analysis and logistic regression will be used to correlated biomarkers with and clinical outcome (e.g., response, clinical benefit, time to progression, progression free survival, and survival) within each study component. Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints. |
| Other | Confirmed Response in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression | Up to 3 years | Confirmed response will be evaluated in patients who crossover from single agent nivolumab to dual agent treatment following progression. |
| Other | Duration of Response in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression | Time from first response to progression, assessed up to 3 years | Evaluated using Kaplan-Meier methodology. |
| Other | PFS in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression | Time from randomization to first of either disease progression or death from any cause, assessed up to 3 years | Evaluated using Kaplan-Meier methodology. |
| Other | OS in Patients Who Crossover From Single Agent Nivolumab to Dual Agent Treatment Following Progression | Time from randomization to death from any cause, assessed up to 3 years | Evaluated using Kaplan-Meier methodology. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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