Trial · NCT02860546
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Immune-Related Overall Response Rate (irORR) | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Efficacy population included all participants in the safety population (all participants who received at least 1 dose of study drug) who completed at least 6 months of tumor follow-up, unless the participant progressed or died before the 6-month follow-up. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (each cycle is of 4 weeks) | DLT Evaluable (DLTE) population included all participants in the safety population in Stage 1, prior to confirming the recommended dose, who completed at least 1 cycle (28 days) of study treatment with at least 80% of the study treatment administered, unless the treatment was interrupted because of a DLT. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Recommended Phase 2 Dose (RP2D) | Cycle 1 (each cycle is of 4 weeks) | DLTE population included all participants in the safety population in Stage 1, prior to confirming the recommended dose, who completed at least 1 cycle (4 weeks) of study treatment with at least 80% of the study treatment administered, unless the treatment was interrupted because of a DLT. | mg/m^2 | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Safety population included all participants who received at least 1 dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Safety population included all participants who received at least 1 dose of study drug. | participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Efficacy population included all participants in the safety population who completed at least 6 months of tumor follow-up, unless the participant progressed or died before the 6-month follow-up. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) Based on Immune Related Response-Criteria (irRC) | From the first dose of study treatment to disease progression or death (up to 53 weeks) | Efficacy population included all participants in the safety population who completed at least 6 months of tumor follow-up, unless the participant progressed or died before the 6-month follow-up. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Based on RECIST Criteria | From the first dose of study treatment to disease progression or death (up to 53 weeks) | Efficacy population included all participants in the safety population who completed at least 6 months of tumor follow-up, unless the participant progressed or died before the 6-month follow-up. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Based on irRC Criteria | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Efficacy population included all participants in the safety population who completed at least 6 months of tumor follow-up, unless the participant progressed or died before the 6-month follow-up. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) Based on RECIST Criteria | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Efficacy population included all participants in the safety population who completed at least 6 months of tumor follow-up, unless the participant progressed or died before the 6-month follow-up. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From first dose of study treatment up to 30 days after the last dose of study treatment (up to 53 weeks) | Safety population included all participants who received at least 1 dose of study drug. Overall number of participants analyzed is 0 because data were not collected for the outcome measure at particular time point. |
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/NCT02860546/outcomes