Trial · NCT01848834
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012)
NCT01848834, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2017-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012). Trials, record NCT01848834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01848834
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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 Advanced Solid Tumors (MK-3475-012/KEYNOTE-012)
- NCT number
- NCT01848834
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 297 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Cancer, Solid Tumor
- Interventions
- Pembrolizumab
- First posted
- 2013-05-08
- Last updated
- 2021-06-28
- Other registries' IDs
- eudract:2012-005771-14
- Results first posted
- 2017-06-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Adverse Events (AEs) | Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C) | An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE was presented for the first course pembrolizumab treatment per protocol. |
| Primary | Number of Participants Discontinuing From Study Treatment Due to an AE | Up to last dose of study treatment (Up to approximately 25 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C) | An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. Some cases of clinical progression that led to discontinuation of study treatment were captured as AEs that led to discontinuation of study treatment. The number of participants who discontinued study treatment due to an AE was presented for the first course pembrolizumab treatment per protocol. |
| Primary | Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B, C, and D) | Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C) | Overall Response Rate (ORR) was defined as the percentage of participants who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who experienced a CR or PR for Cohorts A, B, C and D participants was presented for the first course of pembrolizumab treatment per protocol. Cohorts A, B, C and D enrolled participants with programmed cell death-ligand 1 (PD-L1) positive tumors. |
| Primary | Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2 | Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016 | ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who experienced a CR or PR in Cohort B2 was presented for the first course of pembrolizumab treatment per protocol. |
| Secondary | Overall RECIST 1.1 Response Rate Based on BICR Review, Cohorts B and B2 Human Papilloma Virus (HPV)-Positive Participants | Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016 | ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who had tumors which were HPV positive and who experienced a CR or PR in the combined Cohorts B2 and B2 was presented for the first course of pembrolizumab treatment per protocol. |
| Secondary | Overall RECIST 1.1 Response Rate Based on BICR Review, Cohort D Asia-Pacific (AP) Participants | Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016 | ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who were from the Asia Pacific region and experienced a CR or PR in Cohort D was presented for the first course of pembrolizumab treatment per protocol. |
| Secondary | Overall RECIST 1.1 Response Rate Based on BICR Review, for Participants Previously Treated With Cetuximab and Platinum in Cohorts B and B2 | Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016 | ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who were previously treated with cetuximab and platinum and experienced a CR or PR in the Cohorts B and B2 was presented for the first course of pembrolizumab treatment per protocol. |
| Secondary | Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohorts A, B, C and D | Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C) | ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed by Investigator evaluation. The percentage of participants who experienced a CR or PR in Cohorts A, B, C and D based on investigator assessment was presented for the first course of pembrolizumab treatment per protocol. ORR per RECIST 1.1 based on investigator assessment was presented for Cohort B2 in a separate outcome measure. |
| Secondary | Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohort B2 | Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016 | ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed by Investigator evaluation. The percentage of participants who experienced a CR or PR in Cohort B2 based on investigator assessment was presented for the first course of pembrolizumab treatment per protocol. ORR per RECIST 1.1 based on investigator assessment was presented for the other cohorts in a separate outcome measure. |
| Other | Number of Participants With Log Fold Change From Baseline in Cytokines (Interleukin 10 [IL-10]) >1 | Baseline and Week 8 | IL-10 is an anti-inflammatory cytokine. The number of participants with a log fold change from Baseline in IL-10 \>1 was to be presented. Protocol Amendment 03 (26 May 2015) removed the secondary objective of investigating the relationship between programmed cell death 1 (PD-1) inhibition and up-regulation of cytokines biomarkers predicting response (e.g. IL-10) from the protocol. No data were collected for this outcome measure. |
Source ClinicalTrials.gov
Outcomes10
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 Adverse Events (AEs) | Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C) | The population consisted of all participants who received ≥1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Discontinuing From Study Treatment Due to an AE | Up to last dose of study treatment (Up to approximately 25 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C) | The population consisted of all participants who received ≥1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B, C, and D) | Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C) | The population consisted of Cohorts A, B, C and D participants who received ≥1 dose of study treatment. | Percentage of Participants | NUMBER |
| PRIMARY | Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2 | Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016 | The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | Overall RECIST 1.1 Response Rate Based on BICR Review, Cohorts B and B2 Human Papilloma Virus (HPV)-Positive Participants | Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016 | The population consisted of all Cohort B and Cohort B2 HPV-positive participants who received ≥1 dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | Overall RECIST 1.1 Response Rate Based on BICR Review, Cohort D Asia-Pacific (AP) Participants | Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016 | The population consisted of all Cohort D participants from AP region who received ≥1 dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | Overall RECIST 1.1 Response Rate Based on BICR Review, for Participants Previously Treated With Cetuximab and Platinum in Cohorts B and B2 | Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016 | The population consisted of all Cohort B or B2 participants who progressed following cetuximab and platinum therapy and received ≥1 dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohorts A, B, C and D | Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C) | The population consisted of all Cohort A, B, C and D participants who received ≥1 dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohort B2 | Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016 | The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment. | Percentage of Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Log Fold Change From Baseline in Cytokines (Interleukin 10 [IL-10]) >1 | Baseline and Week 8 | The population was to consist of all allocated participants who: 1) received ≥1 dose of study treatment and 2) had a baseline IL-10 assessment, and 3) had a post baseline IL-10 assessment. No data were collected for this outcome measure. |
Source ClinicalTrials.gov
Results by group23
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 Adverse Events (AEs) | Cohort A: Triple Negative Breast Cancer | 32 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Cohort B: Head & Neck Cancer | 58 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Cohort C: Urothelial Cancer | 33 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Cohort D: Gastric Cancer | 39 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Cohort B2: Head & Neck Cancer Expansion | 130 | Participants | ||
| Number of Participants Discontinuing From Study Treatment Due to an AE | Cohort A: Triple Negative Breast Cancer | 6 | Participants | ||
| Number of Participants Discontinuing From Study Treatment Due to an AE | Cohort B: Head & Neck Cancer | 12 | Participants | ||
| Number of Participants Discontinuing From Study Treatment Due to an AE | Cohort C: Urothelial Cancer | 8 | Participants | ||
| Number of Participants Discontinuing From Study Treatment Due to an AE | Cohort D: Gastric Cancer | 2 | Participants | ||
| Number of Participants Discontinuing From Study Treatment Due to an AE | Cohort B2: Head & Neck Cancer Expansion | 21 | Participants |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Triple Negative Breast Cancer | 32 | |
| Overall Study | STARTED | Cohort B: Head & Neck Cancer | 61 | |
| Overall Study | STARTED | Cohort C: Urothelial Cancer | 33 | |
| Overall Study | STARTED | Cohort D: Gastric Cancer | 39 | |
| Overall Study | STARTED | Cohort B2: Head & Neck Cancer Expansion | 132 | |
| Overall Study | Treated | Cohort A: Triple Negative Breast Cancer | 32 | |
| Overall Study | Treated | Cohort B: Head & Neck Cancer | 60 | |
| Overall Study | Treated | Cohort C: Urothelial Cancer | 33 | |
| Overall Study | Treated | Cohort D: Gastric Cancer | 39 | |
| Overall Study | Treated | Cohort B2: Head & Neck Cancer Expansion | 132 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,315
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 | Cohort A: Triple Negative Breast Cancer | 3 | 32 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B: Head & Neck Cancer | 19 | 60 | 22 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort C: Urothelial Cancer | 7 | 33 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort D: Gastric Cancer | 4 | 39 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B2: Head & Neck Cancer Expansion | 27 | 132 | 32 |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort A: Triple Negative Breast Cancer | 1 | 32 | 5 |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort B: Head & Neck Cancer | 5 | 60 | 6 |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort C: Urothelial Cancer | 1 | 33 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort D: Gastric Cancer | 1 | 39 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Cohort B2: Head & Neck Cancer Expansion | 1 | 132 | 1 |
1 to 10 of 1,315Source ClinicalTrials.gov
See all 1,315 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Triple Negative Breast Cancer | 25 | 32 |
| Total, all-cause mortality | Cohort B: Head & Neck Cancer | 54 | 61 |
| Total, all-cause mortality | Cohort C: Urothelial Cancer | 29 | 33 |
| Total, all-cause mortality | Cohort D: Gastric Cancer | 34 | 39 |
| Total, all-cause mortality | Cohort B2: Head & Neck Cancer Expansion | 110 | 132 |
| Total, other adverse events | Cohort A: Triple Negative Breast Cancer | 31 | 32 |
| Total, other adverse events | Cohort B: Head & Neck Cancer | 58 | 60 |
| Total, other adverse events | Cohort C: Urothelial Cancer | 32 | 33 |
| Total, other adverse events | Cohort D: Gastric Cancer | 37 | 39 |
| Total, other adverse events | Cohort B2: Head & Neck Cancer Expansion | 124 | 132 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers9
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01848834
GET https://conductscience.org/api/trials/v1/NCT01848834/results?page=2