Trial · NCT02460224
Outcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 43
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms | All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001, and who either completed a minimum exposure requirement or who had a DLT during the first 15 days of treatment (1 cycle) for single-agent LAG525 arms or the first 30 days (2 cycles) for the LAG525 + PDR001 arms.~Japanese patients were analyzed together with the rest of the world (ROW) patients as per protocol. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Overall Response Rate (ORR) Per RECIST 1.1 | From start of treatment until end of treatment, assessed up to 2.6 years | All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001. | percentage of participants | NUMBER |
| SECONDARY | Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years. | All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years. | All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 4.4 years. | All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 2.6 years. | All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 4.4 years. | All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001. | percentage | MEAN |
| SECONDARY | Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001 | From start of treatment until end of treatment, assessed up to 2.6 years. | All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001. | percentage | MEAN |
| SECONDARY | Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data. | ug/mL | MEAN |
| SECONDARY | Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data. | ug/mL | MEAN |
| SECONDARY | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data. | days | MEDIAN |
| SECONDARY | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data. | days | MEDIAN |
| SECONDARY | Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data. | day*ug/mL | MEAN |
| SECONDARY | Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data. | day*ug/mL | MEAN |
| SECONDARY | Phase 1: Terminal Elimination Half-life (T1/2) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data. | days | MEAN |
| SECONDARY | Phase 2: Terminal Elimination Half-life (T1/2) of LAG525 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | All patients in phase 2 who received at least one full or partial dose of LAG525 and had a valid measure of the endpoint. | days | MEAN |
| SECONDARY | Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data. | ug/mL | MEAN |
| SECONDARY | Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data. | ug/mL | MEAN |
| SECONDARY | Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W). | All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data. | days | MEDIAN |
| SECONDARY | Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001 | pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W). | All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data. | days | MEDIAN |
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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