TriangleNCT02155647 · STUDY IN CONTEXT
Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200)
Draft scope assessment: unclear. Attached because the study's own record names PD-L1. 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
Confirmed BOR was determined according to RECIST 1.1and as adjudicated by an Independent Endpoint Review Committee(IERC) and defined as best response of any of complete response (CR), partial response(PR), stable disease(SD) and progressive disease(PD) recorded from date of randomization until disease progression/recurrence(taking smallest measurement recorded since start of treatment as reference). CR:Disappearance of all evidence of target/non-target lesions. PR:At least 30%reduction from baseline in sum of longest diameter(SLD) of all lesions. SD:Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD:at least a20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. CR or PR must be confirmed by a subsequent tumor assessment preferably at next scheduled 6-weekly assessment, but no sooner than 5 weeks after initial documentation of CR or PR.
Durable response is defined as an objective response (confirmed complete response \[CR\] or confirmed Partial response \[PR\]) according to Response Evaluation Criteria in Solid Tumors version (RECIST) 1.1, determined by the Independent Endpoint Review Committee (IERC), with a duration of at least 6 months. The DRR was determined as the percentage of participants with an objective response in terms of CR or PR according to RECIST 1.1, as determined by the IERC, with a duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
The duration of response as determined from IERC tumor assessment was calculated for each participant with a confirmed response (CR or PR) as the time from first observation of response until first observation of documented disease progression or death when death occurs within 12 weeks of the last tumor assessment, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Results were calculated based on Kaplan-Meier estimates.
The PFS time (based on IERC tumor assessments), according to the RECIST 1.1, was defined as the time from first administration of study treatment until first observation of PD or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). PFS time (in months) was defined as: (date of PD or death - date of the first dose of study treatment + 1)/30.4375 (months). PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions.
Related Adverse events (AE) were defined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE) as adverse events with relationship to study treatment reported by the investigator. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs. Related TEAEs are defined as events with a relationship of missing, unknown, or yes.
The laboratory measurements included hematology, liver function and blood chemistry. Number of participants with clinically significant abnormalities with Grade greater than or equals to (\>=) 3 in laboratory values reported as TEAEs were reported. Clinically Significance was decided by investigator.
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-1b2e2bfd
- nct id
- NCT02155647
- trial label
- Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200)
- applicability
- unclear
- applicability note
- Attached because the study's own record names PD-L1. 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
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-1b2e2bfd
- nct id
- NCT02155647
- outcome key
- om-0000
- source section id
- NCT02155647-om-0000
- source outcome index
- 0
- endpoint
- Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
- endpoint definition
- Confirmed BOR was determined according to RECIST 1.1and as adjudicated by an Independent Endpoint Review Committee(IERC) and defined as best response of any of complete response (CR), partial response(PR), stable disease(SD) and progressive disease(PD) recorded from date of randomization until disease progression/recurrence(taking smallest measurement recorded since start of treatment as reference). CR:Disappearance of all evidence of target/non-target lesions. PR:At least 30%reduction from baseline in sum of longest diameter(SLD) of all lesions. SD:Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD:at least a20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. CR or PR must be confirmed by a subsequent tumor assessment preferably at next scheduled 6-weekly assessment, but no sooner than 5 weeks after initial documentation of CR or PR.
- time origin
- Up to 113 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-Treat analysis set included all 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-bavencio-1b2e2bfd
- nct id
- NCT02155647
- outcome key
- om-0001
- source section id
- NCT02155647-om-0001
- source outcome index
- 1
- endpoint
- Part B: Durable Response Rate (DRR)
- endpoint definition
- Durable response is defined as an objective response (confirmed complete response \[CR\] or confirmed Partial response \[PR\]) according to Response Evaluation Criteria in Solid Tumors version (RECIST) 1.1, determined by the Independent Endpoint Review Committee (IERC), with a duration of at least 6 months. The DRR was determined as the percentage of participants with an objective response in terms of CR or PR according to RECIST 1.1, as determined by the IERC, with a duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.
- time origin
- Up to 161 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set (FAS) included all 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-bavencio-1b2e2bfd
- nct id
- NCT02155647
- outcome key
- om-0002
- source section id
- NCT02155647-om-0002
- source outcome index
- 2
- endpoint
- Part A: Duration of Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
- endpoint definition
- The duration of response as determined from IERC tumor assessment was calculated for each participant with a confirmed response (CR or PR) as the time from first observation of response until first observation of documented disease progression or death when death occurs within 12 weeks of the last tumor assessment, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Results were calculated based on Kaplan-Meier estimates.
- time origin
- Up to 325 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
- 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-1b2e2bfd
- nct id
- NCT02155647
- outcome key
- om-0003
- source section id
- NCT02155647-om-0003
- source outcome index
- 3
- endpoint
- Part A: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
- endpoint definition
- The PFS time (based on IERC tumor assessments), according to the RECIST 1.1, was defined as the time from first administration of study treatment until first observation of PD or death when death occurred within 12 weeks of the last tumor assessment or first administration of study treatment (whichever was later). PFS time (in months) was defined as: (date of PD or death - date of the first dose of study treatment + 1)/30.4375 (months). PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions.
- time origin
- Up to 325 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-Treat analysis set included all 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-bavencio-1b2e2bfd
- nct id
- NCT02155647
- outcome key
- om-0004
- source section id
- NCT02155647-om-0004
- source outcome index
- 4
- endpoint
- Part A: Number of Participants With Treatment-Related (TR) Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Serious TEAEs and Treatment-Related TEAEs Leading to Death
- endpoint definition
- Related Adverse events (AE) were defined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE) as adverse events with relationship to study treatment reported by the investigator. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs. Related TEAEs are defined as events with a relationship of missing, unknown, or yes.
- time origin
- Up to 325 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety analysis set included all 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-bavencio-1b2e2bfd
- nct id
- NCT02155647
- outcome key
- om-0005
- source section id
- NCT02155647-om-0005
- source outcome index
- 5
- endpoint
- Part A: Number of Participants With Clinically Significant Abnormalities in Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs)
- endpoint definition
- The laboratory measurements included hematology, liver function and blood chemistry. Number of participants with clinically significant abnormalities with Grade greater than or equals to (\>=) 3 in laboratory values reported as TEAEs were reported. Clinically Significance was decided by investigator.
- time origin
- Up to 325 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety analysis set included all 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-1b2e2bfd
- nct id
- NCT02155647
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part A: Avelumab
- regimen
- Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
- analyzed count
- 88
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02155647-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-1b2e2bfd
- nct id
- NCT02155647
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part B: Avelumab
- regimen
- Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
- analyzed count
- 116
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02155647-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-1b2e2bfd
- nct id
- NCT02155647
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Part A: Avelumab
- regimen
- Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02155647-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-1b2e2bfd
- nct id
- NCT02155647
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Part A: Avelumab
- regimen
- Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
- analyzed count
- 88
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02155647-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-1b2e2bfd
- nct id
- NCT02155647
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Part A: Avelumab
- regimen
- Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
- analyzed count
- 88
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02155647-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-1b2e2bfd
- nct id
- NCT02155647
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Part A: Avelumab
- regimen
- Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
- analyzed count
- 88
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02155647-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-merkel-cell-carcinoma-bavencio-1b2e2bfd
- nct id
- NCT02155647
- harm key
- EG000
- source section id
- NCT02155647-ae
- event group key
- EG000
- event group label
- Part A: Avelumab
- serious affected
- 48
- serious at risk
- 88
- other affected
- 86
- other at risk
- 88
- frequency threshold
- 5
- collection period
- Part A: Up to 325 weeks; Part B: Up to 396 weeks
- event definition
- Adverse events were reported as per MedDRA v21.1 for Part A arm and MedDRA v22.0 for Part B.
- undenominated 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-1b2e2bfd
- nct id
- NCT02155647
- harm key
- EG001
- source section id
- NCT02155647-ae
- event group key
- EG001
- event group label
- Part B: Avelumab
- serious affected
- 58
- serious at risk
- 116
- other affected
- 114
- other at risk
- 116
- frequency threshold
- 5
- collection period
- Part A: Up to 325 weeks; Part B: Up to 396 weeks
- event definition
- Adverse events were reported as per MedDRA v21.1 for Part A arm and MedDRA v22.0 for Part B.
- 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