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Trial · NCT01592370

Outcomes28

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants That Experienced Drug Related Grade 3-4 AEsNivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 monthAll Treated ParticipantsParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants That Experienced Drug Related Grade 3-4 SAEsNivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 monthAll Treated ParticipantsParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - LiverNivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 monthAll Treated ParticipantsParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - ThyroidNivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 monthAll Treated ParticipantsParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohortapproximately up to 4 yearsAll treated participants in the nivo dara cohortParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohortapproximately up to 4 yearsAll treated participants in the nivo dara cohortParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematologyapproximately up to 4 yearsAll treated participants in the nivo dara cohortParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liverapproximately up to 4 yearsAll treated participants in the nivo dara cohortParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroidapproximately up to 4 yearsAll treated participants in the nivo dara cohort with at Least One On-Treatment TSH MeasurementParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYBest Overall ResponseNivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 monthAll treated participants with available measurements (excluding Multiple Myeloma (MM) Group)Percentage of participantsNUMBER
SECONDARYBest Overall Response - Multiple Myeloma GroupNivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 monthAll Treated participants with available measurements in the Multiple Myeloma (MM) GroupPercentageNUMBER
SECONDARYDuration of ResponseNivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to approximately 37 months Nivo Liri: approximately up to 4 years 1 monthAll Responding participants (Complete Response and Partial Response) with available measurements (excluding Multiple Myeloma (MM) Group)MonthsMEDIAN
SECONDARYDuration of Response - Multiple Myeloma GroupNivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 monthAll Responding participants (Complete Response and Partial Response) in the Multiple Myeloma (MM) GroupMonthsMEDIAN
SECONDARYProgression Free SurvivalFrom date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months)All Treated Participants with available measurementsMonthsMEDIAN
SECONDARYProgression Free Survival RateFrom randomization to the specified timepoints (up to 48 months)All Treated Participants with available measurementsPercentage of ParticipantsNUMBER
SECONDARYOverall SurvivalNivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to3 years Nivo Liri: approximately up to 4 years 1 monthAll Treated Participants with available measurementsMonthsMEDIAN
SECONDARYNumber of Participants With PD-L1 ExpressionAt baseline (prior to start of study treatment)All Treated ParticipantsNumber of ParticipantsNUMBER
SECONDARYPercentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) ScoreFrom baseline (last measurement before start of study treatment) to last available measurement after start of study treatment (88 weeks for Nivo mono, 93 weeks for nivo+ipi, 25 weeks for nivo+liri)All Treated Participants with cutaneous T Cell lymphoma and available measurementsPercent of change from baselineMEAN
SECONDARYTime to MRD Negativity Status in the Nivolumab + Daratumumab Cohortapproximately up to 4 yearsAll Randomized MRD Evaluable Subjects Achieving MRD NegativityMonthsMEAN
SECONDARYObjective Response Rate in the Nivolumab + Daratumumab Cohortapproximately up to 4 yearsAll randomized participants in the nivo dara cohortPercentageNUMBER

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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