Trial · NCT01295827
Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001)
NCT01295827, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2019-12-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001). Trials, record NCT01295827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01295827
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001)
- NCT number
- NCT01295827
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 1,260 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Cancer, Solid Tumor
- Interventions
- Pembrolizumab
- First posted
- 2011-02-15
- Last updated
- 2019-12-13
- Other registries' IDs
- eudract:2011-002371-42
- Results first posted
- 2019-12-13
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | DLTs were assessed according to NCI-CTCAE v.4.0 during the first cycle (28 days) and were defined as occurrence of any of the following toxicities if judged by the investigator to be possibly, probably or definitely related to study drug administration: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥14 days; Gr 3 nonhematologic toxicity lasting \>3 days despite optimal supportive care; any Grade 3 non-hematologic laboratory value if medical intervention was required to treat the participant, the abnormality led to hospitalization, or the abnormality persisted for \>1 week; Gr 3 or 4 febrile neutropenia; thrombocytopenia \<25,000 cells/mm\^3 (if associated with a bleeding event requiring an elective platelet transfusion, or a life-threatening bleeding event which resulted in urgent intervention and admission to an Intensive Care Unit); or Gr 5 toxicity. The number of participants in Part A and Part A1 with a DLT were reported by pembrolizumab dose received. |
| 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) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who experienced an AE was reported for each arm. |
| 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) | ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1, which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a confirmed CR or PR according to RECIST 1.1 as assessed by IRO was reported as the ORR for each melanoma dose arm (Parts B plus D). |
| 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) | ORR was defined as the percentage of participants in the analysis population who had a confirmed CR (disappearance of all lesions) or PR (at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1, which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a confirmed CR or PR according to RECIST 1.1 as assessed by IRC was reported as the ORR for each NSCLC dose arm (Parts C plus F). |
| 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) | ORR was defined as the percentage of participants in the analysis population who had a confirmed immune-related Complete Response (irCR: complete disappearance of all tumor lesions whether measurable or not, and no new lesions) or immune-related Partial Response (irPR: decrease in sum of the products of the two largest perpendicular diameters (SPD) of ≥50% by a consecutive assessment ≥4 weeks after first documentation) according to irRC. The percentage of participants who experienced a confirmed irCR or irPR according to irRC as assessed by the investigator was reported as the ORR for each melanoma dose arm (Parts B plus D). |
| 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) | ORR was defined as the percentage of participants in the analysis population who had a confirmed irCR (complete disappearance of all tumor lesions whether measurable or not, and no new lesions) or irPR (decrease in sum of the products of the two largest perpendicular diameters (SPD) of ≥50% by a consecutive assessment ≥4 weeks after first documentation) according to irRC. The percentage of participants who experienced a confirmed irCR or irPR according to irRC as assessed by the investigator was reported as the ORR for each NSCLC dose arm (Parts C plus F). |
| 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) | Blood samples were collected at specified intervals for the determination of AUC0-28. AUC0-28 was defined as the area under the concentration-time curve of pembrolizumab from time zero to Day 28. AUC0-28 was based on noncompartmental analysis and reported for participants in Parts A and A1. |
| 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) | Blood samples were collected at specified intervals for the determination of AUC0-inf. AUC0-inf was defined as the area under the concentration-time curve of pembrolizumab from time zero to infinity. AUC0-inf was based on noncompartmental analysis and reported for participants in Parts A and A1. |
| 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) | Blood samples were collected at specified intervals for the determination of Cmax. Cmax was defined as the maximum concentration of pembrolizumab reached. Cmax was based on noncompartmental analysis and reported for participants in Parts A and A1. |
| 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) | Blood samples were collected at specified intervals for the determination of Tmax. Tmax was defined as time to the maximum concentration of pembrolizumab reached. Tmax was based on noncompartmental analysis and reported for participants in Parts A and A1. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group274
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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) | Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) | 0 | Participants | ||
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) | Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) | 0 | Participants | ||
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) | Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) | 0 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) | 4 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) | 3 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) | 9 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) | 4 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) | 3 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) | 6 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) | 161 | Participants |
1 to 10 of 274Source ClinicalTrials.gov
See all 274 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) | 4 | |
| Overall Study | STARTED | Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) | 3 | |
| Overall Study | STARTED | Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) | 12 | |
| Overall Study | STARTED | Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) | 4 | |
| Overall Study | STARTED | Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) | 3 | |
| Overall Study | STARTED | Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) | 6 | |
| Overall Study | STARTED | MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) | 164 | |
| Overall Study | STARTED | MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) | 321 | |
| Overall Study | STARTED | MEL: Pembrolizumab 10 mg/kg Q2W (Part B) | 183 | |
| Overall Study | STARTED | NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) | 61 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events5,652
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) | 1 | 4 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) | 0 | 10 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) | 27 | 162 | 58 |
| other | Anaemia | Blood and lymphatic system disorders | MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) | 61 | 313 | 113 |
| other | Anaemia | Blood and lymphatic system disorders | MEL: Pembrolizumab 10 mg/kg Q2W (Part B) | 30 | 180 | 57 |
| other | Anaemia | Blood and lymphatic system disorders | NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) | 5 | 61 | 5 |
1 to 10 of 5,652Source ClinicalTrials.gov
See all 5,652 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A) | 2 | 4 |
| Total, all-cause mortality | Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A) | 1 | 3 |
| Total, all-cause mortality | Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1) | 6 | 12 |
| Total, all-cause mortality | Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2) | 2 | 4 |
| Total, all-cause mortality | Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2) | 1 | 3 |
| Total, all-cause mortality | Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2) | 5 | 6 |
| Total, all-cause mortality | MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D) | 111 | 164 |
| Total, all-cause mortality | MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D) | 213 | 321 |
| Total, all-cause mortality | MEL: Pembrolizumab 10 mg/kg Q2W (Part B) | 110 | 183 |
| Total, all-cause mortality | NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F) | 52 | 61 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers24
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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