Trial · NCT03189719
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in Participants With Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] ≥10) | Up to approximately 34 months | All randomized participants (ITT population) with ESCC and PD-L1 CPS ≥10 were analyzed. | Months | MEDIAN |
| PRIMARY | OS in Participants With ESCC | Up to approximately 34 months | All randomized participants (ITT population) with ESCC were analyzed. | Months | MEDIAN |
| PRIMARY | OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | Up to approximately 34 months | All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed. | Months | MEDIAN |
| PRIMARY | OS in All Participants | Up to approximately 34 months | All randomized participants (ITT population) were analyzed. | Months | MEDIAN |
| PRIMARY | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) As Assessed By Investigator in Participants With ESCC | Up to approximately 34 months | All randomized participants (ITT population) with ESCC were analyzed. | Months | MEDIAN |
| PRIMARY | PFS Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | Up to approximately 34 months | All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed. | Months | MEDIAN |
| PRIMARY | PFS Per RECIST 1.1 As Assessed By Investigator in All Participants | Up to approximately 34 months | All randomized participants (ITT population) were analyzed. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per RECIST 1.1 As Assessed By Investigator in All Participants | Up to approximately 34 months | All randomized participants (ITT population) were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | Up to approximately 34 months | All randomized participants (ITT population) with ESCC and PD-L1 CPS ≥10 were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC | Up to approximately 34 months | All randomized participants (ITT population) with ESCC were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | ORR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | Up to approximately 34 months | All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per RECIST 1.1 As Assessed By Investigator in All Participants | Up to approximately 34 months | All randomized participants (ITT population) who demonstrated a confirmed CR or PR were analyzed. | Months | MEDIAN |
| SECONDARY | DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | Up to approximately 34 months | All randomized participants (ITT population) with ESCC and PD-L1 CPS ≥10 who demonstrated a confirmed CR or PR were analyzed were analyzed. | Months | MEDIAN |
| SECONDARY | DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC | Up to approximately 34 months | All randomized participants (ITT population) with ESCC who demonstrated a confirmed CR or PR were analyzed. | Months | MEDIAN |
| SECONDARY | DOR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | Up to approximately 34 months | All randomized participants (ITT population) who were PD-L1 CPS ≥10 and who demonstrated a confirmed CR or PR were analyzed. | Months | MEDIAN |
| SECONDARY | Number of Participants With an Adverse Event (AE) | Up to approximately 28 months | All randomized participants who received at least one dose of study treatment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Discontinuing Study Treatment Due to an AE | Up to approximately 27 months | All randomized participants who received at least one dose of study treatment were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline To Week 18 in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Combined Score in All Participants | Baseline, Week 18 | All randomized participants who received at least one dose of study treatment and completed at least 1 EORTC-QLQ-C30 assessment were analyzed. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10) | Baseline, Week 18 | All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC-QLQ-C30 assessment, who had ESCC, and who were PD-L1 CPS ≥10 were analyzed. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC | Baseline, Week 18 | All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC-QLQ-C30 assessment, and who had ESCC were analyzed. | Score on a Scale | LEAST_SQUARES_MEAN |
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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