Trial · NCT01592370
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants That Experienced Drug Related Grade 3-4 AEs | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug. |
| Primary | Number of Participants That Experienced Drug Related Grade 3-4 SAEs | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | Number and percent of participants that experienced drug related Grade 3-4 SAEs occurring up to 100 days after the last dose of study drug. |
| Primary | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug. |
| Primary | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | |
| Primary | Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | |
| Primary | Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | |
| Primary | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | approximately up to 4 years | |
| Primary | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | approximately up to 4 years | |
| Primary | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | approximately up to 4 years | |
| Secondary | Best Overall Response | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response |
| Secondary | Best Overall Response - Multiple Myeloma Group | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. |
| Secondary | Duration of Response | Nivo 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 month | the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Remission and Partial Remission |
| Secondary | Duration of Response - Multiple Myeloma Group | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response |
| Secondary | Progression Free Survival | From date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months) | Progression free survival (PFS) is defined as the time between date of randomization and date of progression or death, whichever occurs first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Subjects who did not progress or die were censored on the date of their last efficacy assessment. |
| Secondary | Progression Free Survival Rate | From randomization to the specified timepoints (up to 48 months) | The percentage of participants remaining progression free at the specified timepoints (up to 48 Months) |
| Secondary | Overall Survival | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to3 years Nivo Liri: approximately up to 4 years 1 month | The percentage of participants remaining alive. Median values are computed using Kaplan-Meier method |
| Secondary | Number of Participants With PD-L1 Expression | At baseline (prior to start of study treatment) | Number of Participants with PD-L1 expression in the following categories * baseline PD-L1 expression ≥ 1% * baseline PD-L1 expression \< 1% * without PD-L1 quantifiable at baseline |
| Secondary | Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score | From 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) | mSWAT is a scoring technique involving the direct assessment of the percentage of body-surface-area (BSA) affected by skin lesions. There are 12 body regions (each one assigned a different percentage of BSA). For each body region, the assigned BSA percentage is multiplied by a factor weighing the type and severity of lesion observed (patch= x1, plaque = x2, tumor= x4). The sum of the individual body region sub-scores is then summed to generate the final mSWAT score, which ranges from 0 (best outcome) to 400 (worst outcome). |
| Secondary | Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | Time to MRD Negativity status in specific NGS and NGF sensitivity levels |
| Secondary | Objective Response Rate in the Nivolumab + Daratumumab Cohort | approximately up to 4 years |
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.
For software
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