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Trial · NCT03675737

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYOverall Survival (OS) in All ParticipantsUp to 45.9 monthsThe analysis population included all randomized participants.MonthsMEDIAN
PRIMARYOverall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1Up to 45.9 monthsThe analysis population included randomized participants with a PD-L1 CPS of ≥1.MonthsMEDIAN
PRIMARYOverall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10Up to 45.9 monthsThe analysis population included randomized participants with a PD-L1 CPS of ≥10.MonthsMEDIAN
SECONDARYProgression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All ParticipantsUp to 49.5 monthsThe analysis population included all randomized participants.MonthsMEDIAN
SECONDARY
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
Up to 49.5 monthsThe analysis population included randomized participants with a PD-L1 CPS ≥1.MonthsMEDIAN
SECONDARY
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
Up to 49.5 monthsThe analysis population included randomized participants with a PD-L1 CPS ≥10.MonthsMEDIAN
SECONDARYObjective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All ParticipantsUp to 49.5 monthsThe analysis population included all randomized participants.Percentage of ParticipantsNUMBER
SECONDARY
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
Up to 49.5 monthsThe analysis population included randomized participants with a PD-L1 CPS ≥1.Percentage of ParticipantsNUMBER
SECONDARY
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
Up to 49.5 monthsThe analysis population included randomized participants with a PD-L1 CPS ≥10.Percentage of ParticipantsNUMBER
SECONDARYDuration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All ParticipantsUp to 49.5 monthsThe analysis population included all randomized participants who experienced a confirmed CR or PR.MonthsMEDIAN
SECONDARY
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
Up to 49.5 monthsThe analysis population included randomized participants, with a PD-L1 CPS ≥1, who experienced a confirmed CR or PR.MonthsMEDIAN
SECONDARY
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
Up to 49.5 monthsThe analysis population included randomized participants, with a PD-L1 CPS ≥10, who experienced a confirmed CR or PR.MonthsMEDIAN
SECONDARYNumber of Participants Who Experienced an Adverse Event (AE)Up to approximately 49.3 monthsThe analysis population included all participants who received at least one dose of study treatment.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)Up to approximately 46.3 monthsThe analysis population included all participants who received at least one dose of study treatment.ParticipantsCOUNT_OF_PARTICIPANTS

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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