Trial · NCT02853305
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pembro Combo vs Chemo: Progression-free Survival (PFS) Using Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 42 months | All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro Combo vs Chemo: Overall Survival (OS) | Up to approximately 42 months | All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis. | Months | MEDIAN |
| PRIMARY | Pembro vs Chemo: OS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10% | Up to approximately 42 months | All participants in the ITT population randomized to the pembro arm and chemo arm who were PD-L1 CPS ≥10% were included in the analysis. Per protocol, the pembro combo arm was not pre-specified as part of this analysis and is not included. | Months | MEDIAN |
| PRIMARY | Pembro vs Chemo: OS | Up to approximately 42 months | All participants in the ITT population randomized to the pembro arm and chemo arm were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis. | Months | MEDIAN |
| SECONDARY | Pembro vs Chemo: PFS Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | All participants in the ITT population randomized to the pembro arm and chemo arm were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis. | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 55 months | All randomized participants who received at least 1 dose of trial treatment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinue Study Drug Due to an AE | Up to approximately 52 months | All randomized participants who received at least 1 dose of trial treatment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pembro Combo vs Chemo: Objective Response Rate (ORR) Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Pembro Combo vs Chemo: Duration of Response (DOR) Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | All participants in the ITT population randomized to the pembro combo arm and chemo arm and who demonstrated a confirmed CR or PR were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis. | Months | MEDIAN |
| SECONDARY | Pembro Combo vs Chemo: Disease Control Rate (DCR) Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Pembro vs Chemo: ORR Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | All participants in the ITT population randomized to the pembro arm and chemo arm were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Pembro vs Chemo: DOR Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | All participants in the ITT population randomized to the pembro arm and chemo arm who demonstrated a confirmed CR or PR were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis. | Months | MEDIAN |
| SECONDARY | Pembro vs Chemo: DCR Using RECIST 1.1 as Assessed by BICR | Up to approximately 42 months | All participants in the ITT population randomized to the pembro arm and chemo arm were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | PFS Using RECIST 1.1 as Assessed by BICR at 6 Months | 6 months | All participants in the ITT population (all randomized) were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | PFS Using RECIST 1.1 as Assessed by BICR at 12 Months | 12 months | All participants in the ITT population (all randomized) were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | PFS Using RECIST 1.1 as Assessed by BICR at 18 Months | 18 months | All participants in the ITT population (all randomized) were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Pembro Combo vs Chemo: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score | Baseline, Week 18 | All participants in the ITT population randomized to the pembro combo arm and chemo arm who received at least 1 dose of study drug and who completed at least 1 EORTC-QLQ-C30 assessment were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and is not included in this analysis. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pembro Combo vs Chemo: Time to Deterioration (TTD) in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score | Baseline up to approximately 25 months | All participants in the ITT population randomized to the pembro combo arm and chemo arm who received at least 1 dose of study drug and who had an EORTC-QLQ-C30 assessment at baseline were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and is not included in this analysis. | Months | MEDIAN |
| SECONDARY | Pembro vs Chemo: Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score | Baseline, Week 18 | All participants in the ITT population randomized to the pembro arm and chemo arm who received at least 1 dose of study drug and who completed at least 1 EORTC-QLQ-C30 assessment were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and is not included in this analysis. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pembro vs Chemo: TTD in the EORTC-QLQ-C30 GHS/QoL (Items 29 and 30) Combined Score | Baseline up to approximately 25 months | All participants in the ITT population randomized to the pembro arm and chemo arm who received at least 1 dose of study drug and who had an EORTC-QLQ-C30 assessment at baseline were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and is not included in this analysis. | Months | MEDIAN |
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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