TriangleNCT03783078 · STUDY IN CONTEXT
Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
OS was defined as the time from the first dose of study treatment until death from any cause.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- trial label
- Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- outcome key
- om-0000
- source section id
- NCT03783078-om-0000
- source outcome index
- 0
- endpoint
- Objective Response Rate (ORR)
- endpoint definition
- 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.
- time origin
- Up to ~34 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population consisted of all allocated participants who received at least 1 dose of study treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- outcome key
- om-0001
- source section id
- NCT03783078-om-0001
- source outcome index
- 1
- endpoint
- Duration of Response (DOR)
- endpoint definition
- 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.
- time origin
- Up to ~58 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- outcome key
- om-0002
- source section id
- NCT03783078-om-0002
- source outcome index
- 2
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- 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.
- time origin
- Up to ~58 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population consisted of all allocated participants who received at least 1 dose of study treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- outcome key
- om-0003
- source section id
- NCT03783078-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival (OS)
- endpoint definition
- OS was defined as the time from the first dose of study treatment until death from any cause.
- time origin
- Up to ~58 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population consisted of all allocated participants who received at least 1 dose of study treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- outcome key
- om-0004
- source section id
- NCT03783078-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With One or More Adverse Events (AEs)
- endpoint definition
- 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.
- time origin
- Up to ~58 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population consisted of all allocated participants who received at least one dose of study treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- outcome key
- om-0005
- source section id
- NCT03783078-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants Who Discontinued From Study Treatment Due to an AE
- endpoint definition
- 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.
- time origin
- Up to ~27 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population consisted of all allocated participants who received at least one dose of study treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Pembrolizumab 200 mg
- regimen
- Adult participants received pembrolizumab (MK-3475) 200 mg or pediatric participants received 2 mg/kg (up to 200 mg) on Day 1 Q3W IV for up to 35 administrations (approximately 2 years).
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03783078-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Pembrolizumab 200 mg
- regimen
- Adult participants received pembrolizumab (MK-3475) 200 mg or pediatric participants received 2 mg/kg (up to 200 mg) on Day 1 Q3W IV for up to 35 administrations (approximately 2 years).
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03783078-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Pembrolizumab 200 mg
- regimen
- Adult participants received pembrolizumab (MK-3475) 200 mg or pediatric participants received 2 mg/kg (up to 200 mg) on Day 1 Q3W IV for up to 35 administrations (approximately 2 years).
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03783078-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Pembrolizumab 200 mg
- regimen
- Adult participants received pembrolizumab (MK-3475) 200 mg or pediatric participants received 2 mg/kg (up to 200 mg) on Day 1 Q3W IV for up to 35 administrations (approximately 2 years).
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03783078-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Pembrolizumab 200 mg
- regimen
- Adult participants received pembrolizumab (MK-3475) 200 mg or pediatric participants received 2 mg/kg (up to 200 mg) on Day 1 Q3W IV for up to 35 administrations (approximately 2 years).
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03783078-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Pembrolizumab 200 mg
- regimen
- Adult participants received pembrolizumab (MK-3475) 200 mg or pediatric participants received 2 mg/kg (up to 200 mg) on Day 1 Q3W IV for up to 35 administrations (approximately 2 years).
- analyzed count
- 55
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03783078-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma
- nct id
- NCT03783078
- harm key
- EG000
- source section id
- NCT03783078-ae
- event group key
- EG000
- event group label
- Pembrolizumab 200 mg
- serious affected
- 24
- serious at risk
- 55
- other affected
- 49
- other at risk
- 55
- frequency threshold
- 5
- collection period
- Up to ~58 months
- event definition
- All-cause mortality includes all allocated participants. AEs include participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE, unless related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice