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Trial · NCT03382600

Outcomes13

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYObjective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR)Up to ~36 monthsAll participants who received ≥1 dose of study treatment are included.Percentage of participantsNUMBER
SECONDARYORR According to Immune-related Response Evaluation Criteria In Solid Tumors (iRECIST) Assessed by BICRUp to ~36 monthsAll participants who received ≥1 dose of study drug are included.Percentage of participantsNUMBER
SECONDARYDuration of Response (DOR) According to RECIST 1.1 Assessed by BICRUp to ~36 monthsAll participants who received ≥1 dose of study drug and had a confirmed response of CR or PR are included.monthsMEDIAN
SECONDARYDOR According to iRECIST Assessed by BICRUp to ~36 monthsAll participants who received ≥1 dose of study drug and had a confirmed response of CR or PR are included.monthsMEDIAN
SECONDARYDisease Control Rate (DCR) According to RECIST 1.1 Assessed by BICRUp to ~36 monthsAll participants who received ≥1 dose of study drug are included.Percentage of participantsNUMBER
SECONDARYDCR According to iRECIST 1.1 Assessed by BICRUp to ~36 monthsAll participants who received ≥1 dose of study drug are included.Percentage of participantsNUMBER
SECONDARYTime to Response (TTR) According to RECIST 1.1 Assessed by BICRUp to ~36 monthsAll participants who received ≥1 dose of study drug are included.monthsMEDIAN
SECONDARYTTR According to iRECIST 1.1 Assessed by BICRUp to ~36 monthsAll participants who received ≥1 dose of study drug are included.monthsMEDIAN
SECONDARYProgression-free Survival (PFS) According to RECIST 1.1 Assessed by BICRUp to ~36 monthsAll participants who received ≥1 dose of study drug are included.monthsMEDIAN
SECONDARYPFS According to iRECIST 1.1 Assessed by BICRUp to ~36 monthsAll participants who received ≥1 dose of study drug are included.monthsMEDIAN
SECONDARYOverall Survival (OS)Up to ~36 monthsAll participants who received ≥1 dose of study drug are included.monthsMEDIAN
SECONDARYNumber of Participants With ≥1 Adverse Event (AE)Up to ~36 monthsAll participants who received ≥1 dose of study drug are included.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Discontinuing From Study Treatment Due to AE(s)Up to ~36 monthsAll participants who received ≥1 dose of study drug are included.ParticipantsCOUNT_OF_PARTICIPANTS

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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