Trial · NCT02155647
Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200)
NCT02155647, Phase 2, Completed, EMD Serono Research & Development Institute, Inc.; results first posted 2020-07-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200). Trials, record NCT02155647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02155647
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200)
- NCT number
- NCT02155647
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 204 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Carcinoma, Merkel Cell
- Interventions
- Avelumab
- First posted
- 2014-06-04
- Last updated
- 2024-03-13
- Other registries' IDs
- eudract:2014-000445-79
- Results first posted
- 2020-07-22
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Up to 113 weeks | 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. |
| Primary | Part B: Durable Response Rate (DRR) | Up to 161 weeks | 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. |
| Secondary | Part A: Duration of Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Up to 325 weeks | 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. |
| Secondary | Part A: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Up to 325 weeks | 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. |
| Secondary | 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 | Up to 325 weeks | 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. |
| Secondary | Part A: Number of Participants With Clinically Significant Abnormalities in Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs) | Up to 325 weeks | 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. |
| Secondary | Part A: Number of Participants With Clinically Significant Abnormalities in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs) | Up to 325 weeks | Vital signs including body temperature, body weight, respiratory rate, heart rate (after 5-minute rest), and arterial blood pressure (after 5-minute rest) were evaluated. Number of participants with clinically significant abnormalities in Vital Signs reported as TEAEs. Clinically Significance was decided by investigator. |
| Secondary | Part A: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | Up to 325 weeks | A 12-lead ECG was recorded after the participant has been in a supine position breathing quietly for 5 minutes. The ECG results was used to evaluate the heart rate, atrial ventricular conduction, PR interval, QRS, QTcF and QTcB. Number of participants with clinical significant abnormalities in ECG parameter reported here. Clinically Significance was decided by investigator. |
| Secondary | Part A: Interim Analysis: Overall Survival (OS) Time | Up to 87 weeks (Data reported are per pre-specified interim analysis with a data cut-off date of 3 Mar 2016) | The OS time was defined as the time from first administration of trial treatment until death. The OS time was analyzed using the Kaplan-Meier method. |
| Secondary | Part A: Final Analysis: Overall Survival (OS) Time | Time from first administration of trial treatment until death (Up to 325 weeks) | The OS time was defined as the time from first administration of trial treatment until death. The OS time was analyzed using the Kaplan-Meier method. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Up to 113 weeks | Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Durable Response Rate (DRR) | Up to 161 weeks | Full analysis set (FAS) included all participants who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Part A: Duration of Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Up to 325 weeks | 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. | Months | MEDIAN |
| SECONDARY | Part A: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Up to 325 weeks | Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment. | Months | MEDIAN |
| SECONDARY | 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 | Up to 325 weeks | Safety analysis set included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Number of Participants With Clinically Significant Abnormalities in Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs) | Up to 325 weeks | Safety analysis set included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Number of Participants With Clinically Significant Abnormalities in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs) | Up to 325 weeks | Safety analysis set included all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | Up to 325 weeks | Safety analysis set included all participants who received at least 1 dose of study treatment. Here Number of participants analyzed signifies those who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Interim Analysis: Overall Survival (OS) Time | Up to 87 weeks (Data reported are per pre-specified interim analysis with a data cut-off date of 3 Mar 2016) | Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment. | Months | MEDIAN |
| SECONDARY | Part A: Final Analysis: Overall Survival (OS) Time | Time from first administration of trial treatment until death (Up to 325 weeks) | Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment. | months | MEDIAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group115
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Part A: Avelumab | Complete Response | 10 | Participants | |
| Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Part A: Avelumab | Partial Response | 19 | Participants | |
| Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Part A: Avelumab | Stable Disease | 9 | Participants | |
| Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Part A: Avelumab | Non-complete Response/ Non-progressive Disease | 0 | Participants | |
| Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Part A: Avelumab | Progressive Disease | 32 | Participants | |
| Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Part A: Avelumab | Not evaluable | 18 | Participants | |
| Part B: Durable Response Rate (DRR) | Part B: Avelumab | 30.2 | 95% Confidence Interval 22.0 to 39.4 | Percentage of participants | |
| Part A: Duration of Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Part A: Avelumab | 40.5 | Full Range 2.8 to 41.5 | Months | |
| Part A: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Part A: Avelumab | 2.7 | Full Range 0.03 to 45.6 | Months | |
| 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 | Part A: Avelumab | Participants with TR-TEAEs | 68 | Participants |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Avelumab | 88 | |
| Overall Study | STARTED | Part B: Avelumab | 116 | |
| Overall Study | COMPLETED | Part A: Avelumab | 88 | |
| Overall Study | COMPLETED | Part B: Avelumab | 116 | |
| Overall Study | NOT COMPLETED | Part A: Avelumab | 0 | |
| Overall Study | NOT COMPLETED | Part B: Avelumab | 0 |
Source ClinicalTrials.gov
Adverse events406
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 | Part A: Avelumab | 14 | 88 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: Avelumab | 19 | 116 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Part A: Avelumab | 7 | 88 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Part B: Avelumab | 9 | 116 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Part A: Avelumab | 0 | 88 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Part B: Avelumab | 6 | 116 | |
| other | Abdominal pain | Gastrointestinal disorders | Part A: Avelumab | 11 | 88 | |
| other | Abdominal pain | Gastrointestinal disorders | Part B: Avelumab | 11 | 116 | |
| other | Constipation | Gastrointestinal disorders | Part A: Avelumab | 16 | 88 | |
| other | Constipation | Gastrointestinal disorders | Part B: Avelumab | 29 | 116 |
1 to 10 of 406Source ClinicalTrials.gov
See all 406 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Avelumab | 63 | 88 |
| Total, all-cause mortality | Part B: Avelumab | 72 | 116 |
| Total, other adverse events | Part A: Avelumab | 86 | 88 |
| Total, other adverse events | Part B: Avelumab | 114 | 116 |
| Total, serious adverse events | Part A: Avelumab | 48 | 88 |
| Total, serious adverse events | Part B: Avelumab | 58 | 116 |
Source ClinicalTrials.gov
Papers15
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 |
|---|---|
| Part A: Avelumab vs Part B: Avelumab: deaths from any cause | Trial comparisons |
| Part A: Avelumab vs Part B: Avelumab: 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.
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GET https://conductscience.org/api/trials/v1/NCT02155647
GET https://conductscience.org/api/trials/v1/NCT02155647/registered?page=2