Trial · NCT03522246
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 | Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS) | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Primary | Monotherapy Arm B and Arm D: Investigator Assessed PFS | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Primary | Combination Therapy Arm A and Arm B: Investigator Assessed PFS | From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months) | PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Secondary | Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Secondary | Monotherapy Arm B and Arm D: BICR PFS | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Secondary | Combination Therapy Arm A and Arm B: BICR PFS | From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months) | PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Secondary | Monotherapy Arm B and Arm D: Overall Survival (OS) | From randomization until death due to any cause (up to the primary data analysis at approximately 36 months) | OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause. |
| Secondary | Monotherapy Arm B and Arm D: OS | From randomization until death due to any cause (up to the primary data analysis at approximately 40 months) | OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause. |
| Secondary | Combination Therapy Arm A and Arm B: OS | From randomization until death due to any cause (up to the combination therapy interim analysis at approximately 72 months) | OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause. |
| Secondary | Monotherapy Arm B and Arm D: Objective Response Rate (ORR) | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | ORR was defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Monotherapy Arm B and Arm D: ORR | From randomization until disease progression (up to the primary data analysis at approximately 39 months) | ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Combination Therapy Arm A and Arm B: ORR | From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months) | ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Monotherapy Arm B and Arm D: Duration of Response (DOR) | From first confirmed response until disease progression (up to the primary data analysis at approximately 30 months) | DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of progressive disease (PD) or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Secondary | Monotherapy Arm B and Arm D: DOR | From first confirmed response until disease progression (up to the primary data analysis at approximately 33 months) | DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of PD or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
| Secondary | Combination Therapy Arm A and Arm B: DOR | From first confirmed response until disease progression (up to the combination therapy interim analysis at approximately 60 months) | DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of PD or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s). |
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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