Trial · NCT03740165
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS]≥10) | Up to approximately 67 months | The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| PRIMARY | PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants | Up to approximately 67 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Participants With PD-L1 Positive Tumors (CPS ≥ 10) | Up to approximately 67 months | The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | OS in All Participants | Up to approximately 67 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) in Participants With PD-L1 Positive Tumors (CPS≥10) | Up to approximately 66 months | The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | PFS Per RECIST 1.1 as Assessed by BICR in All Participants | Up to approximately 66 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | PFS After Second-line Treatment (PFS2) Following Discontinuation of Study Treatment as Assessed by the Investigator in Participants With PD-L1 Positive Tumors (CPS≥10) | Up to approximately 67 months | The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | PFS2 Following Discontinuation of Study Treatment as Assessed by the Investigator in All Participants | Up to approximately 67 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) (GHS/QoL) Combined Score | Baseline and week 45 | The analysis population includes all randomized participants who have at least 1 GHS/QoL assessment available and received at least 1 dose of study medication. Participants were analyzed in the treatment group to which they were randomized. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Abdominal and Gastrointestinal (Abdominal/GI) Symptoms Score Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale | Baseline and week 45 | The analysis population includes all randomized participants who have at least 1 Abdominal/GI Symptom Scale assessment available and received at least 1 dose of study medication. Participants were analyzed in the treatment group to which they were randomized. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Deterioration (TTD) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score | Up to approximately 31 months | The analysis population includes all randomized participants who have at least 1 GHS/QoL assessment available plus a baseline assessment, and received at least 1 dose of study medication. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Time to Deterioration (TTD) of Abdominal/GI Symptoms Using EORTC QLQ-OV28 | Up to approximately 31 months | The analysis population includes all randomized participants who have at least 1 Abdominal/GI Symptom Scale assessment available plus a baseline assessment, and received at least 1 dose of study medication. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Time to First Subsequent Anti-cancer Treatment (TFST) in Participants With PD-L1 Positive Tumors (CPS≥10) | Up to approximately 67 months | The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Time to First Subsequent Anti-cancer Treatment (TFST) in All Participants | Up to approximately 67 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Time to Second Subsequent Anti-cancer Treatment (TSST) in Participants With PD-L1 Positive Tumors (CPS≥10) | Up to approximately 67 months | The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Time to Second Subsequent Anti-cancer Treatment (TSST) in All Participants | Up to approximately 67 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Time to Discontinuation of Study Treatment or Death (TDT) in Participants With PD-L1 Positive Tumors (CPS≥10) | Up to approximately 67 months | The analysis population includes all randomized participants with CPS≥10. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Time to Discontinuation of Study Treatment or Death (TDT) in All Participants | Up to approximately 67 months | The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Pathological Complete Response (pCR) Rate in Participants With PD-L1 Positive Tumors (CPS≥10) | Up to approximately 21 months | The analysis population includes all randomized participants with CPS≥10 who had pCR evaluation. Participants were analyzed in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Pathological Complete Response (pCR) Rate in All Participants | Up to approximately 26 months | The analysis population includes all randomized participants who had pCR evaluation. Participants were analyzed in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
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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