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Trial · NCT03615326

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICRGlobal Pembrolizumab + Standard of Care First Course10.095% Confidence Interval 8.6 to 12.2Months
Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICRGlobal Standard of Care8.195% Confidence Interval 7.0 to 8.5Months
Overall Survival (OS)Global Pembrolizumab + Standard of Care First Course20.095% Confidence Interval 17.8 to 22.1Months
Overall Survival (OS)Global Standard of Care First Course16.895% Confidence Interval 14.9 to 18.7Months
Objective Response Rate (ORR) Per RECIST 1.1 Assessed by BICRGlobal Pembrolizumab + Standard of Care First Course72.695% Confidence Interval 67.6 to 77.2Percentage of Participants
Objective Response Rate (ORR) Per RECIST 1.1 Assessed by BICRGlobal Standard of Care First Course60.195% Confidence Interval 54.7 to 65.2Percentage of Participants
Duration of Response (DOR) Per RECIST 1.1 Assessed by BICRGlobal Pembrolizumab + Standard of Care First Course11.1395% Confidence Interval 9.8 to 12.7Months
Duration of Response (DOR) Per RECIST 1.1 Assessed by BICRGlobal Standard of Care First Course9.595% Confidence Interval 7.2 to 11.2Months
Number of Participants Who Experienced an Adverse Event (AE)Global Pembrolizumab + Standard of Care First Course348Participants
Number of Participants Who Experienced an Adverse Event (AE)Global Standard of Care First Course346Participants
Number of Participants Who Experienced an Adverse Event (AE)Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin20Participants
Number of Participants Who Experienced an Adverse Event (AE)Japan Trastuzumab + S-1 Plus Oxaliplatin20Participants
Number of Participants Who Discontinued Study Treatment Due to AEsGlobal Pembrolizumab + Standard of Care First Course150Participants
Number of Participants Who Discontinued Study Treatment Due to AEsGlobal Standard of Care First Course136Participants
Number of Participants Who Discontinued Study Treatment Due to AEsJapan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin11Participants
Number of Participants Who Discontinued Study Treatment Due to AEsJapan Trastuzumab + S-1 Plus Oxaliplatin11Participants

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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