Trial · NCT01295827
Outcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) | Up to 28 days in Cycle 1 | All participants in Parts A and A1 who received ≥1 dose of study treatment and either 1) had a DLT in Cycle 1 or 2) received ≥90% of the prescribed dose of pembrolizumab in Cycle 1 and completed all safety evaluations ≥28 days after the first administration of pembrolizumab without experiencing DLT. Per protocol, Parts A2 and B-F were not analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018) | All participants who received at least 1 dose of study treatment. | Participants | NUMBER |
| PRIMARY | Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) | Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015) | All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis. | Percentage of Participants | NUMBER |
| PRIMARY | ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) | Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015) | All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | ORR According to Immune-related Response Criteria (irRC) as Assessed by Investigator in Melanoma Participants (Parts B Plus D) | Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015) | All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | ORR According to irRC as Assessed by Investigator in NSCLC Participants (Parts C Plus F) | Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015) | All NSCLC (Parts C plus F) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Area Under the Concentration-Time Curve of Pembrolizumab From Time 0 to Day 28 (AUC 0-28) in Solid Tumor Participants (Parts A and A1) | Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days) | All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available AUC0-28 data. Two participants were excluded from analysis due to discontinuation. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose pharmacokinetic (PK) analysis. | μg•day/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-Time Curve of Pembrolizumab From Time 0 to Infinity (AUC 0-inf) in Solid Tumor Participants (Parts A and A1) | Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days) | All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available AUC0-inf data. Two participants were excluded from analysis due to discontinuation. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose PK analysis. | μg•day/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Concentration (Cmax) of Pembrolizumab in Solid Tumor Participants (Parts A and A1) | Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days) | All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available Cmax data. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose PK analysis. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Maximum Concentration (Tmax) of Pembrolizumab in Solid Tumor Participants (Parts A and A1) | Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days) | All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available Tmax data. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose PK analysis. | days | MEDIAN |
| SECONDARY | Terminal Half-Life (t ½) of Pembrolizumab in Solid Tumor Participants (Parts A and A1) | Cycle 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours and Days 8, 15, and 22 (Cycle 1 = 28 days) | All participants in Parts A and A1 receiving a single dose of drug during Cycle 1 (28 days) and having available t½ data. Two participants were excluded from analysis due to discontinuation. Per protocol, participants in Parts A2, B, C, D, C, and F were not included in the single dose PK analysis. | days | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-Time Curve of Pembrolizumab From Time 0 to Day 21 (AUC 0-21) in Solid Tumor Participants (Part A2) | Cycle 1: Day 1: Pre-dose, post-dose at 0.5, 6, 24, and 48 hours; Day 5, Day 8: pre- and post-dose; Day 15 (Cycle = 21 days) | All participants in Part A2 receiving escalating doses of drug during Cycle 1 (21 days) and having available AUC0-21 data. One participant was excluded from analysis due to discontinuation. Per protocol, participants in Parts A, A1, B, C, D, C, and F were not included in the escalating dose PK analysis. | μg•day/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-Time Curve of Pembrolizumab From Day 21 to Day 42 (AUC21-42) in Solid Tumor Participants (Part A2) | Cycle 1: Day 21; Cycle 2: Day 1: Pre-dose, post-dose at 0.5 and 24 hours, Day 3, Day 8, Day 15 (Cycle = 21 days) | All participants in Part A2 receiving escalating doses of drug during Cycle 1 and having available AUC21-42 data during Cycle 2. Two participants were excluded from analysis due to discontinuation. Per protocol, participants in Parts A, A1, B, C, D, C, and F were not included in the escalating dose PK analysis. | μg•day/mL | GEOMETRIC_MEAN |
| SECONDARY | Lowest Plasma Concentration (Ctrough) of Pembrolizumab in Solid Tumor Participants (Parts A, A1, and A2) | Parts A and A1: pre-dose at Cycles 2, 4, 6, 8, 10, 12, 14 (cycle=14 days); A2 Cohorts: pre-dose at Cycles 2, 3, 5, 7, 9, 11 (cycle=21 days) | All Part A participants receiving ≥1 dose of drug and having available Ctrough samples collected pre-dose before each cycle. Due to differing dosing schedules or N\<1, some time points were not applicable for certain arms if data were not collected or analyzed (indicated by zero participants analyzed entered in the table). | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Ctrough of Pembrolizumab in Melanoma Participants (Parts B and D) | Part B arms treated every 3 weeks: pre-dose at Cycles 2,5,9,13,17,25,33 (cycle=21 days); Part B treated every 2 weeks: pre-dose at Cycles 2,3,7,13,19,25,31,37 (cycle=14 days); Part D: pre-dose at Cycles 2,3,6,8,12,16,24,32 (cycle=21 days) | All melanoma participants receiving ≥1 dose of drug and having available samples collected pre-dose before each cycle. Per protocol, Ctrough analyzed separately by Part, dose, and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms (indicated by zero participants analyzed entered in the table). | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Ctrough of Pembrolizumab in NSCLC Participants (Parts C and F) | Part C: pre-dose at Cycles 2,5,9,13,17,21 (cycle=21 days); Part F treated every 3 weeks: pre-dose at Cycles 2,3,6,8,12,14,16,24,32 (cycle=21 days); Part F treated every 2 weeks: pre-dose at Cycles 2,3,6,7,8,9,12,16,18,24,32,36,40,48 (cycle=14 days) | All NSCLC participants receiving ≥1 dose of drug and having available samples collected pre-dose before each cycle. Per protocol, Ctrough analyzed separately by Part, dose, and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms (indicated by zero participants analyzed entered in the table). | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Change From Baseline (CFB) in Tumor Size Assessed by IRC Per RECIST 1.1 According to Programmed Death-Ligand 1 (PD-L1) Immunohistochemical (IHC) Expression Status in Ipilimumab (Ipi)-Exposed and Ipi-Naive Melanoma Participants (Parts B Plus D) | Baseline, last available tumor assessment (up to approximately 53 months through Interim Database cut-off date of 18-Sep-2015) | Melanoma participants that received ≥1 dose of study treatment, had a valid PD-L1 expression measurement, and had both baseline and post-baseline tumor assessments. Per protocol, Part A was not analyzed for biomarker analysis. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Change From Baseline (CFB) in Tumor Size Assessed by IRC Per RECIST 1.1 According to PD-L1 IHC Expression Status in Prior Treatment (TRT)-Naïve and Previously-Treated NSCLC Participants (Parts C Plus F) | Baseline, last available tumor assessment (up to approximately 53 months through Interim Database cut-off date of 18-Sep-2015) | NSCLC participants that received ≥1 dose of study treatment, had a valid PD-L1 expression measurement, and had both baseline and post-baseline tumor assessments. Per protocol, Part A was not analyzed for biomarker analysis. Melanoma (Parts B plus D) participants were analyzed and presented separately and are not included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) According to RECIST 1.1 as Assessed by IRO in Melanoma Participants (Parts B and D) | Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015) | All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment. Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) According to RECIST 1.1 as Assessed by IRO in Melanoma Participants (Parts B and D) | From time of first documented evidence of CR or PR through Interim Database cut-off date of 18-Sep-2015 (Up to approximately 53 months) | All melanoma (Parts B plus D) participants that received ≥1 dose of study treatment and who demonstrated a confirmed response (CR or PR). Per protocol, Part A (dose-escalation) was not analyzed for efficacy. NSCLC (Parts C plus F) participants were analyzed and presented separately and are not included in this analysis. | Weeks | 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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