TriangleNCT02267603 · STUDY IN CONTEXT
Pembrolizumab in Treating Patients With Advanced Merkel Cell Cancer
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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
This will include immunohistochemical and gene expression analysis focusing on delineating the immune components and immunologic milieu within the tumor before therapy.
ORR will be estimated as the number of responders as a percent of the number of eligible participants who received at least one dose of treatment. If a substantial amount of data is missing, analyses will be performed using parametric generalized linear models fit by maximum likelihood. A generalized linear model for the ORR will use a binomial error distribution. The model will include as covariates all available baseline predictors of the missing outcomes. Responses to continued pembrolizumab will be chronicled and reported.
Survival curves for PFS will be estimated using the Kaplan-Meier method. Assessed percentage of participants with progression free survival up to 16 months.
Survival curves for DOR will be estimated using the Kaplan-Meier method.
Survival curves for OS will be estimated using the Kaplan-Meier method.
Safety will be assessed by quantifying the toxicities and grades experienced by subjects including serious AEs (SAEs) and events of clinical interest. Safety and tolerability will be assessed by clinical review of all relevant parameters including AEs, laboratory tests, vital signs, and electrocardiogram measurements. Assessed number of participants who experienced grade 3 to 5 adverse events.
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-bavencio-430a0e45
- nct id
- NCT02267603
- trial label
- Pembrolizumab in Treating Patients With Advanced Merkel Cell Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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-bavencio-430a0e45
- nct id
- NCT02267603
- outcome key
- om-0005
- source section id
- NCT02267603-om-0005
- source outcome index
- 5
- endpoint
- Immune Correlates of the Clinical Activity of Pembrolizumab
- endpoint definition
- This will include immunohistochemical and gene expression analysis focusing on delineating the immune components and immunologic milieu within the tumor before therapy.
- time origin
- Baseline
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- 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-bavencio-430a0e45
- nct id
- NCT02267603
- outcome key
- om-0000
- source section id
- NCT02267603-om-0000
- source outcome index
- 0
- endpoint
- Objective Response Rate (ORR) Defined as the Proportion of Patients Who Have Achieved Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- endpoint definition
- ORR will be estimated as the number of responders as a percent of the number of eligible participants who received at least one dose of treatment. If a substantial amount of data is missing, analyses will be performed using parametric generalized linear models fit by maximum likelihood. A generalized linear model for the ORR will use a binomial error distribution. The model will include as covariates all available baseline predictors of the missing outcomes. Responses to continued pembrolizumab will be chronicled and reported.
- time origin
- Up to 3 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- 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-bavencio-430a0e45
- nct id
- NCT02267603
- outcome key
- om-0001
- source section id
- NCT02267603-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival (PFS) Using RECIST 1.1
- endpoint definition
- Survival curves for PFS will be estimated using the Kaplan-Meier method. Assessed percentage of participants with progression free survival up to 16 months.
- time origin
- Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 16 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- 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-bavencio-430a0e45
- nct id
- NCT02267603
- outcome key
- om-0002
- source section id
- NCT02267603-om-0002
- source outcome index
- 2
- endpoint
- Duration of Response (DOR)
- endpoint definition
- Survival curves for DOR will be estimated using the Kaplan-Meier method.
- time origin
- Time interval between the date of first response (CR/PR) and the date of progression, assessed up to 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Thirty participants with durable response were assessed by RECIST 1.1.
- 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-bavencio-430a0e45
- nct id
- NCT02267603
- outcome key
- om-0003
- source section id
- NCT02267603-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival (OS)
- endpoint definition
- Survival curves for OS will be estimated using the Kaplan-Meier method.
- time origin
- Time interval between the start of treatment to death due to any cause, assessed up to 60 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- 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-bavencio-430a0e45
- nct id
- NCT02267603
- outcome key
- om-0004
- source section id
- NCT02267603-om-0004
- source outcome index
- 4
- endpoint
- Incidence of Adverse Events (AEs) Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
- endpoint definition
- Safety will be assessed by quantifying the toxicities and grades experienced by subjects including serious AEs (SAEs) and events of clinical interest. Safety and tolerability will be assessed by clinical review of all relevant parameters including AEs, laboratory tests, vital signs, and electrocardiogram measurements. Assessed number of participants who experienced grade 3 to 5 adverse events.
- time origin
- Up to 90 days post-treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- 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-bavencio-430a0e45
- nct id
- NCT02267603
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab)
- regimen
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression\* or unacceptable toxicity. \* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years. Laboratory Biomarker Analysis: Ancillary studies Pembrolizumab: Given IV
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02267603-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-430a0e45
- nct id
- NCT02267603
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab)
- regimen
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression\* or unacceptable toxicity. \* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years. Laboratory Biomarker Analysis: Ancillary studies Pembrolizumab: Given IV
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02267603-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-430a0e45
- nct id
- NCT02267603
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab)
- regimen
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression\* or unacceptable toxicity. \* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years. Laboratory Biomarker Analysis: Ancillary studies Pembrolizumab: Given IV
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02267603-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-430a0e45
- nct id
- NCT02267603
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab)
- regimen
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression\* or unacceptable toxicity. \* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years. Laboratory Biomarker Analysis: Ancillary studies Pembrolizumab: Given IV
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02267603-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-430a0e45
- nct id
- NCT02267603
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Pembrolizumab)
- regimen
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression\* or unacceptable toxicity. \* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years. Laboratory Biomarker Analysis: Ancillary studies Pembrolizumab: Given IV
- analyzed count
- 50
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02267603-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-430a0e45
- nct id
- NCT02267603
- harm key
- EG000
- source section id
- NCT02267603-ae
- event group key
- EG000
- event group label
- Treatment (Pembrolizumab)
- serious affected
- 22
- serious at risk
- 50
- other affected
- 50
- other at risk
- 50
- frequency threshold
- 1
- collection period
- Serious Adverse Events and other (not including serious) adverse events were assessed for up to 36 months. All cause mortality was assessed for up to 60 months.
- event definition
- Source null
- 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