Trial · NCT03783078
Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)
NCT03783078, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2023-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913). Trials, record NCT03783078. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03783078
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)
- NCT number
- NCT03783078
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 55 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Merkel Cell Carcinoma
- Interventions
- Pembrolizumab (MK-3475)
- First posted
- 2018-12-20
- Last updated
- 2025-05-28
- Other registries' IDs
- eudract:2018-002601-57
- Results first posted
- 2023-02-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to ~34 months | ORR was defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by blinded independent central review (BICR) were presented. |
| Secondary | Duration of Response (DOR) | Up to ~58 months | For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per 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 RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented. |
| Secondary | Progression-free Survival (PFS) | Up to ~58 months | Progression-Free Survival was defined as the time from the first dose of study treatment to the first documented evidence of disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥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 ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented. |
| Secondary | Overall Survival (OS) | Up to ~58 months | OS was defined as the time from the first dose of study treatment until death from any cause. |
| Secondary | Number of Participants With One or More Adverse Events (AEs) | Up to ~58 months | An AE was 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 ~27 months | An AE was 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 from study treatment due to an AE was assessed. |
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 | Objective Response Rate (ORR) | Up to ~34 months | The analysis population consisted of all allocated participants who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to ~58 months | The analysis population consisted of all allocated participants who received at least 1 dose of study treatment, and who experienced a confirmed CR or confirmed PR. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Up to ~58 months | The analysis population consisted of all allocated participants who received at least 1 dose of study treatment. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to ~58 months | The analysis population consisted of all allocated participants who received at least 1 dose of study treatment. | Months | MEDIAN |
| SECONDARY | Number of Participants With One or More Adverse Events (AEs) | Up to ~58 months | The analysis population consisted of all allocated participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued From Study Treatment Due to an AE | Up to ~27 months | The analysis population consisted of all allocated participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Pembrolizumab 200 mg | 49.1 | 95% Confidence Interval 35.4 to 62.9 | Percentage of participants | |
| Duration of Response (DOR) | Pembrolizumab 200 mg | 39.8 | 95% Confidence Interval 23.8 to NA | Months | |
| Progression-free Survival (PFS) | Pembrolizumab 200 mg | 9.3 | 95% Confidence Interval 3.0 to 25.5 | Months | |
| Overall Survival (OS) | Pembrolizumab 200 mg | 24.3 | 95% Confidence Interval 12.4 to NA | Months | |
| Number of Participants With One or More Adverse Events (AEs) | Pembrolizumab 200 mg | 52 | Participants | ||
| Number of Participants Who Discontinued From Study Treatment Due to an AE | Pembrolizumab 200 mg | 18 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab 200 mg | 55 | |
| Overall Study | COMPLETED | Pembrolizumab 200 mg | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab 200 mg | 55 |
Source ClinicalTrials.gov
Adverse events74
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 | Pembrolizumab 200 mg | 9 | 55 | 11 |
| other | Vertigo | Ear and labyrinth disorders | Pembrolizumab 200 mg | 3 | 55 | 4 |
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab 200 mg | 3 | 55 | 3 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab 200 mg | 3 | 55 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Pembrolizumab 200 mg | 5 | 55 | 6 |
| other | Constipation | Gastrointestinal disorders | Pembrolizumab 200 mg | 9 | 55 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | Pembrolizumab 200 mg | 7 | 55 | 11 |
| other | Dry mouth | Gastrointestinal disorders | Pembrolizumab 200 mg | 5 | 55 | 5 |
| other | Nausea | Gastrointestinal disorders | Pembrolizumab 200 mg | 8 | 55 | 10 |
| other | Vomiting | Gastrointestinal disorders | Pembrolizumab 200 mg | 5 | 55 | 5 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab 200 mg | 32 | 55 |
| Total, other adverse events | Pembrolizumab 200 mg | 49 | 55 |
| Total, serious adverse events | Pembrolizumab 200 mg | 24 | 55 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39377880 | RESULT |
Source PubMed
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/NCT03783078
GET https://conductscience.org/api/trials/v1/NCT03783078/events?page=2