Trial · NCT02054806
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)
NCT02054806, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2023-10-30
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-3475-028/KEYNOTE-28). Trials, record NCT02054806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02054806
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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-3475-028/KEYNOTE-28)
- NCT number
- NCT02054806
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 477 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Solid Tumor
- Interventions
- Pembrolizumab
- First posted
- 2014-02-04
- Last updated
- 2023-10-30
- Other registries' IDs
- eudract:2013-004507-39
- Results first posted
- 2023-10-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to approximately 86 months | 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 modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 28 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed. |
| Secondary | Number of Participants Who Discontinued From Study Treatment Due to an AE | Up to approximately 25 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed. |
| Secondary | Progression Free Survival (PFS) | Up to approximately 86 months | PFS was defined as the time from the date of allocation to the date of the first documentation of disease progression, as determined by investigator per modified RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \[mm\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method. |
| Secondary | Overall Survival (OS) | Up to approximately 86 months | OS was defined as the time from the date of allocation to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the end of the trial were censored at the date of last assessment. |
| Secondary | Duration of Response (DOR) | Up to approximately 86 months | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per modified RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per modified RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on investigator with confirmation. The DOR according to modified RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported. Per protocol, participants were analyzed according to disease type. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Up to approximately 86 months | The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 28 months | The analysis population consisted of all allocated participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued From Study Treatment Due to an AE | Up to approximately 25 months | The analysis population consisted of all allocated participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | Up to approximately 86 months | The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 86 months | The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | Up to approximately 86 months | The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1, had the intended indication, and experienced a response. Per protocol-specified definition, DOR could not be analyzed in arms which did not have a confirmed response of CR or PR. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Cohort A1: Colon or Rectal Adenocarcinoma | 4.3 | 95% Confidence Interval 0.1 to 21.9 | Percentage of Participants | |
| Overall Response Rate (ORR) | Cohort A2: Anal Canal Squamous Cell Carcinoma | 20.0 | 95% Confidence Interval 6.8 to 40.7 | Percentage of Participants | |
| Overall Response Rate (ORR) | Cohort A3: Pancreas Adenocarcinoma | 0.0 | 95% Confidence Interval 0.0 to 14.2 | Percentage of Participants | |
| Overall Response Rate (ORR) | Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma | 30.4 | 95% Confidence Interval 13.2 to 52.9 | Percentage of Participants | |
| Overall Response Rate (ORR) | Cohort A5: Biliary Tract Adenocarcinoma | 17.4 | 95% Confidence Interval 5.0 to 38.8 | Percentage of Participants | |
| Overall Response Rate (ORR) | Cohort A6: Carcinoid Tumors | 16.0 | 95% Confidence Interval 4.5 to 36.1 | Percentage of Participants | |
| Overall Response Rate (ORR) | Cohort A7: Neuroendocrine Carcinomas | 6.3 | 95% Confidence Interval 0.2 to 30.2 | Percentage of Participants | |
| Overall Response Rate (ORR) | Cohort B1: ER Positive HER2 Negative Breast Cancer | 12.0 | 95% Confidence Interval 2.5 to 31.2 | Percentage of Participants | |
| Overall Response Rate (ORR) | Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma | 11.5 | 95% Confidence Interval 2.4 to 30.2 | Percentage of Participants | |
| Overall Response Rate (ORR) | Cohort B3: Endometrial Carcinoma | 13.0 | 95% Confidence Interval 2.8 to 33.6 | Percentage of Participants |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab 10 mg/kg | 477 | |
| Overall Study | Treated During First Course | Pembrolizumab 10 mg/kg | 475 | |
| Overall Study | Treated During Second Course | Pembrolizumab 10 mg/kg | 11 | |
| Overall Study | COMPLETED | Pembrolizumab 10 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab 10 mg/kg | 477 |
Source ClinicalTrials.gov
Adverse events476
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 | First Course Pembrolizumab 10 mg/kg | 87 | 475 | 101 |
| other | Anaemia | Blood and lymphatic system disorders | Second Course Pembrolizumab 10 mg/kg | 0 | 11 | 0 |
| other | Hypothyroidism | Endocrine disorders | First Course Pembrolizumab 10 mg/kg | 38 | 475 | 39 |
| other | Hypothyroidism | Endocrine disorders | Second Course Pembrolizumab 10 mg/kg | 0 | 11 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | First Course Pembrolizumab 10 mg/kg | 54 | 475 | 59 |
| other | Abdominal pain | Gastrointestinal disorders | Second Course Pembrolizumab 10 mg/kg | 0 | 11 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | First Course Pembrolizumab 10 mg/kg | 28 | 475 | 31 |
| other | Abdominal pain upper | Gastrointestinal disorders | Second Course Pembrolizumab 10 mg/kg | 1 | 11 | 1 |
| other | Constipation | Gastrointestinal disorders | First Course Pembrolizumab 10 mg/kg | 93 | 475 | 105 |
| other | Constipation | Gastrointestinal disorders | Second Course Pembrolizumab 10 mg/kg | 1 | 11 | 1 |
1 to 10 of 476Source ClinicalTrials.gov
See all 476 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | First Course Pembrolizumab 10 mg/kg | 426 | 477 |
| Total, all-cause mortality | Second Course Pembrolizumab 10 mg/kg | 6 | 11 |
| Total, other adverse events | First Course Pembrolizumab 10 mg/kg | 429 | 475 |
| Total, other adverse events | Second Course Pembrolizumab 10 mg/kg | 10 | 11 |
| Total, serious adverse events | First Course Pembrolizumab 10 mg/kg | 160 | 475 |
| Total, serious adverse events | Second Course Pembrolizumab 10 mg/kg | 3 | 11 |
Source ClinicalTrials.gov
Papers18
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| First Course Pembrolizumab 10 mg/kg vs Second Course Pembrolizumab 10 mg/kg: deaths from any cause | Trial comparisons |
| First Course Pembrolizumab 10 mg/kg vs Second Course Pembrolizumab 10 mg/kg: serious adverse events | Trial comparisons |
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/NCT02054806
GET https://conductscience.org/api/trials/v1/NCT02054806/results?page=2