Trial · NCT03132636
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) as Assessed by Independent Central Review (ICR) | Up to 1422 days (approximately 46 months) | Full analysis set (FAS) (included all enrolled participants for each group who passed screening and were deemed to be eligible for this study) | Percentage of Participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) Per Investigator Assessment | Up to 1422 days (approximately 46 months) | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Assessed by ICR | Up to 48 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Here, Overall number of participants analyzed signifies those participants with confirmed CR or PR. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Per Investigator Assessment | Up to 48 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Here, Overall number of participants analyzed signifies those participants with confirmed CR or PR. | Months | MEDIAN |
| SECONDARY | Complete Response (CR) Rate as Assessed by ICR | Up to 48 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. | Percentage of Participants | NUMBER |
| SECONDARY | Complete Response (CR) Rate Per Investigator Assessment | Up to 48 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. | Percentage of Participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) as Assessed by ICR | Up to 60 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Per Investigator Assessment | Up to 60 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 60 months | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. | Months | MEDIAN |
| SECONDARY | Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Baseline (Day 1 of Cycle 1); Day 1 of Cycles 2 to 9 (Cycles 1-5 [Each cycle of 9 weeks], Cycles 6 to 9 [Each cycle of 12 weeks]) | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Number analyzed signifies those participants who were evaluable at specific time points. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire | Baseline (Day 1 of Cycle 1); Day 1 of Cycles 2 to 9 (Cycles 1-5 [Each cycle of 9 weeks], Cycles 6 to 9 [Each cycle of 12 weeks]) | The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Number analyzed signifies those participants who were evaluable at specific time points. | Score on a Scale | MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Up to 1422 days (approximately 46 months) | The safety analysis set (SAF) included all enrolled participants who received any study drug for each group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum Concentration at Pre-infusion (Ctrough) | At pre-infusion on Cycle 1 Day 22 and Cycle 3 Day 1 (Each cycle of 9 weeks) | The PK analysis set included all participants who received any cemiplimab and had at least one non-missing post-baseline measurement of cemiplimab concentration in serum. Number analyzed signifies those participants who were evaluable at specific time points. | Milligram per Liter (mg/L) | MEAN |
| SECONDARY | Serum Concentration at End of Infusion (Cmax) | At end-of-infusion (within 10 minutes after the end of infusion) on Cycle 1 Day 1 and Cycle 3 Day 1 (Each cycle of 9 weeks) | The pharmacokinetics (PK) analysis set included all participants who received any cemiplimab and had at least one non-missing post-baseline measurement of cemiplimab concentration in serum. Number analyzed signifies those participants who were evaluable at specific time points. | mg/L | MEAN |
| SECONDARY | Number of Participants With Anti-Drug Antibody (ADA) Status | Cycle 1: Days 1 and 43; Cycles 3 and 5: Day 1 (Each cycle of 9 weeks) | The anti-drug antibody set included all participants who received cemiplimab and who had at least 1 non-missing result in the ADA assay after the first dose of the study drug. | Participants | COUNT_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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03132636/outcomes