Trial · NCT02595866
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Observed Adverse Events (AEs) | Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. | Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall. If the numbers are sufficient, the results may additionally be stratified by tumor type. |
| Primary | Incidence of Immune-related Events of Clinical Interest (irECI) | Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. | This includes the occurrence of grade 2 or higher AEs. Will be graded using CTCAE version 4.0 (version 5.0 beginning April 1, 2018). Any AE of unknown etiology associated with study therapy will be evaluated to determine if it is possibly an ECI of a potentially immunologic etiology or related to combination antiretroviral therapy (cART). All summaries will be presented for each cohort and overall. If the numbers are sufficient, the results may additionally be stratified by tumor type. |
| Primary | Incidence of cART-related ECIs of Grade 2 or Higher AEs | Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. | Will be graded using CTCAE version 4.0 (version 5.0 beginning April 1, 2018). Any AE of unknown etiology associated with study therapy will be evaluated to determine if it is possibly an ECI of a potentially immunologic etiology or related to cART. All summaries will be presented for each cohort and overall. If the numbers are sufficient, the results may additionally be stratified by tumor type. |
| Secondary | Objective Response Rate (Cohorts 1-3) | Up to 2 years | Defined as the proportion of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, "Lugano Criteria" for Malignant Lymphoma or other tumor-specific criteria. Analyzed using Clopper-Pearson 95% confidence intervals. |
| Secondary | Progression-free Survival (Cohorts 1-3) | From the first dose of study drug to progressive disease or death, whichever occurs earlier, assessed up to 25 months | Assessed using RECIST 1.1, "Lugano Criteria" for Malignant Lymphoma or other tumor-specific criteria. Summarized statistically using Kaplan-Meier method. |
| Secondary | Duration of Response (Cohorts 1-3) | Interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years | Defined in participants experiencing CR or PR using RECIST 1.1, "Lugano Criteria" for malignant lymphoma or other tumor-specific criteria. Summarized statistically using Kaplan-Meier method. |
| Secondary | Overall Survival (Cohorts 1-3) | From the first dose of study drug to death due to any cause, assessed up to 3 years | Summarized statistically using Kaplan-Meier method. |
| Secondary | Objective Response Rate (Partial Response + Completion Response)(Kaposi Sarcoma Cohort) | Up to 2 years | Defined as the proportion of participants who achieved the best objective response rate (complete response (CR) + partial response (PR)) as determined by modified Acquired Immunodeficiency Syndrome Clinical Trials Group (ACTG) criteria Analyzed using Clopper-Pearson 95% confidence intervals. |
| Secondary | Progression-free Survival (Kaposi Sarcoma Cohort) | From the first dose of study drug to progressive disease or death, whichever occurs earlier, assessed up to 3 years | Assessed using ACTG criteria. Summarized statistically using Kaplan-Meier method. |
| Secondary | Duration of Response (Kaposi Sarcoma Cohort) | Interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years | Assessed using ACTG criteria. Summarized statistically using Kaplan-Meier method. |
| Secondary | Overall Survival (Kaposi Sarcoma Cohort) | From the first dose of study drug to death due to any cause, assessed up to 3 years | Summarized statistically using Kaplan-Meier method. |
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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