Trial · NCT03257267
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 28
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Cemiplimab | 11.7 | 95% Confidence Interval 9.6 to 13.4 | Months | |
| Overall Survival (OS) | Investigator Choice (IC) Chemotherapy | 8.5 | 95% Confidence Interval 7.5 to 9.6 | Months | |
| Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Cemiplimab | 2.8 | 95% Confidence Interval 2.6 to 3.9 | Months | |
| Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Investigator Choice (IC) Chemotherapy | 2.9 | 95% Confidence Interval 2.7 to 3.5 | Months | |
| Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1 | Cemiplimab | 52 | Participants | ||
| Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1 | Investigator Choice (IC) Chemotherapy | 19 | Participants | ||
| Duration of Response (DOR) Assessed Per RECIST 1.1 | Cemiplimab | 18.7 | 95% Confidence Interval 16.4 to NA | Months | |
| Duration of Response (DOR) Assessed Per RECIST 1.1 | Investigator Choice (IC) Chemotherapy | 7.2 | 95% Confidence Interval 5.1 to 9.9 | Months | |
Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | Cemiplimab | Overall: Change from Baseline of EORTC QLQ-C30 GHS/QoL | 0.46 | 95% Confidence Interval -2.715 to 3.642 | Score on a Scale |
Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | Investigator Choice (IC) Chemotherapy | Overall: Change from Baseline of EORTC QLQ-C30 GHS/QoL | -8.54 | 95% Confidence Interval -13.004 to -4.084 | Score on a Scale |
Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | Cemiplimab | Overall: Changes from Baseline of EORTC QLQ-C30 Physical Functioning | -0.27 | 95% Confidence Interval -3.014 to 2.473 | Score on a Scale |
Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales | Investigator Choice (IC) Chemotherapy | Overall: Changes from Baseline of EORTC QLQ-C30 Physical Functioning | -8.86 | 95% Confidence Interval -12.517 to -5.196 | Score on a Scale |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | Cemiplimab | Participants with any TEAE | 269 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | Investigator Choice (IC) Chemotherapy | Participants with any TEAE | 266 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | Cemiplimab | Participants with any Serious TEAE | 96 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | Investigator Choice (IC) Chemotherapy | Participants with any Serious TEAE | 78 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | Cemiplimab | Participants with any TEAE leading to Death | 5 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death | Investigator Choice (IC) Chemotherapy | Participants with any TEAE leading to Death | 2 | Participants | |
| Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | Cemiplimab | Hematology (Grades 3/4) | 84 | Participants | |
| Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade | Investigator Choice (IC) Chemotherapy | Hematology (Grades 3/4) | 137 | 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
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GET https://conductscience.org/api/trials/v1/NCT03257267/results