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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02155647




Registration number
NCT02155647
Ethics application status
Date submitted
2/06/2014
Date registered
4/06/2014
Date last updated
22/07/2020

Titles & IDs
Public title
Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200)
Scientific title
A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma
Secondary ID [1] 0 0
2014-000445-79
Secondary ID [2] 0 0
100070-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Merkel Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Avelumab

Experimental: Part A: Avelumab - 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.

Experimental: Part B: Avelumab - 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.


Treatment: Drugs: Avelumab
Avelumab was administered 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 - 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.
Timepoint [1] 0 0
Up to 87 weeks
Primary outcome [2] 0 0
Part B: Durable Response Rate (DRR) - 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.
Timepoint [2] 0 0
Up to 161 weeks
Secondary outcome [1] 0 0
Part A: Duration of Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 - 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.
Timepoint [1] 0 0
Up to 87 weeks
Secondary outcome [2] 0 0
Part A: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 - 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.
Timepoint [2] 0 0
Up to 87 weeks
Secondary outcome [3] 0 0
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 - 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.
Timepoint [3] 0 0
Up to 87 weeks
Secondary outcome [4] 0 0
Part A: Number of Participants With Clinically Significant Abnormalities in Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs) - 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.
Timepoint [4] 0 0
Up to 87 weeks
Secondary outcome [5] 0 0
Part A: Number of Participants With Clinically Significant Abnormalities in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs) - 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.
Timepoint [5] 0 0
Up to 87 weeks
Secondary outcome [6] 0 0
Part A: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) - 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.
Timepoint [6] 0 0
Up to 87 weeks
Secondary outcome [7] 0 0
Part A: Interim Analysis: Overall Survival (OS) Time - 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.
Timepoint [7] 0 0
Up to 87 weeks (Data reported are per pre-specified interim analysis with a data cut-off date of 3 Mar 2016)
Secondary outcome [8] 0 0
Part A: Final Analysis: Overall Survival (OS) Time - 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.
Timepoint [8] 0 0
Pre-specified final analysis: Time from first administration of trial treatment until death (Up to 513 weeks)
Secondary outcome [9] 0 0
Part A: Participant's Response Status According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 at 6 and 12 Months - The response status at 6 and 12 months after start of trial treatment according to RECIST 1.1 (as determined by the IERC) was determined. A participant was considered to be in response at the given timepoint (6 or 12 months after the start of the participant's treatment) if the participant had a documented response (PR or CR) prior to that timepoint, and neither died nor experienced disease progression according to the RECIST 1.1 nor was lost to follow-up up to the given timepoint. 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. Percentage of participants in response and not in response according to RECIST1.1 at 6 and 12 months were reported.
Timepoint [9] 0 0
At Month 6 and 12
Secondary outcome [10] 0 0
Part A: Number of Participants With Positive Treatment Emergent Anti-Avelumab Antibodies - Serum samples were analyzed by a validated electrochemiluminesce immunoassay to detect the presence of anti-avelumab antibodies. Samples that screened positive were subsequently tested in a confirmatory assay. Those confirmed positive were titered for a quasi-quantitative result. Number of participants with positive treatment emergent anti-Avelumab antibodies were reported. Participants not positive prior to treatment with avelumab and with at least one positive result in the human-Antihuman Antibodies assay were characterized as treatment-emergent.
Timepoint [10] 0 0
Up to 80 weeks
Secondary outcome [11] 0 0
Part A: Serum Concentration at End of Infusion (CEOI) of Avelumab - Serum concentration at end of infusion (CEOI) of Avelumab is reported.
Timepoint [11] 0 0
Day 1, 43, 85, 169, 253, 337 and 421
Secondary outcome [12] 0 0
Part A: Minimum Serum Post-dose (Ctrough) Concentration of Aveluamb - Minimum serum post-dose (Ctrough) concentration of avelumab was reported.
Timepoint [12] 0 0
Day 15, 29, 43, 57, 71, 85, 99, 169, 211, 253, 337 and 421
Secondary outcome [13] 0 0
Part B: Interim Analysis: Overall Survival (OS) Time - The OS time was defined as the time from first administration of study treatment until the date of death. OS was calculated using following formula = (date of death - date of the first dose of study treatment + 1)/30.4375 (months).
Timepoint [13] 0 0
Up to 161 weeks (Data reported are per pre-specified interim analysis with a data cut-off date of 2 May 2019)
Secondary outcome [14] 0 0
Part B: Final Analysis: Overall Survival (OS) Time - The OS time was defined as the time from first administration of study treatment until the date of death. OS was calculated using following formula = (date of death - date of the first dose of study treatment + 1)/30.4375 (months).
Timepoint [14] 0 0
Pre-specified final analysis: Time from first administration of trial treatment until death (Up to 422 weeks)
Secondary outcome [15] 0 0
Part B: Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 - 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.
Timepoint [15] 0 0
Up to 161 weeks
Secondary outcome [16] 0 0
Part B: Duration of Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 - 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.
Timepoint [16] 0 0
Up to 161 weeks
Secondary outcome [17] 0 0
Part B: Progression-Free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 - 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.
Timepoint [17] 0 0
Up to 161 weeks
Secondary outcome [18] 0 0
Part B: Number of Participants With Treatment-Related (TR) Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Serious TEAEs and Treatment-Related TEAEs Leading to Death - 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.
Timepoint [18] 0 0
Up to 161 weeks
Secondary outcome [19] 0 0
Part B: Participant's Response Status According to RECIST 1.1 at 6 and 12 Months - The response status at 6 and 12 months after start of trial treatment according to RECIST 1.1 (as determined by the IERC) was determined. A participant was considered to be in response at the given timepoint (6 or 12 months after the start of the participant's treatment) if the participant had a documented response (PR or CR) prior to that timepoint, and neither died nor experienced disease progression according to the RECIST 1.1 nor was lost to follow-up up to the given timepoint. 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. Percentage of participants in response and not in response according to RECIST1.1 at 6 and 12 months were reported.
Timepoint [19] 0 0
At Month 6 and 12
Secondary outcome [20] 0 0
Part B: Number of Participants With Positive Treatment Emergent Anti-Avelumab Antibodies - Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Samples that screened positive were subsequently tested in a confirmatory assay. Those that confirmed positive were titered for a quasi-quantitative result. Number of participants with positive treatment emergent anti-Avelumab antibodies were reported. Participants not positive prior to treatment with avelumab and with at least one positive result in the human-Antihuman Antibodies assay were characterized as treatment-emergent.
Timepoint [20] 0 0
Up to 161 weeks
Secondary outcome [21] 0 0
Part B: Serum Concentration at End of Infusion (CEOI) of Avelumab - Serum concentration at end of infusion (CEOI) of Avelumab is reported.
Timepoint [21] 0 0
At Day 1, 43 and 169
Secondary outcome [22] 0 0
Part B: Minimum Serum Post-dose (Ctrough) Concentration of Aveluamb - Minimum serum post-dose (Ctrough) concentration of avelumab was reported.
Timepoint [22] 0 0
Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505, Day 589, Day 673

Eligibility
Key inclusion criteria
- Signed written informed consent

- Age 18 years and above

- Histologically proven MCC

- Participants must have received at least 1 line of chemotherapy for metastatic MCC and
must have progressed after the most recent line of chemotherapy

- For Part B - Participants must not have received any prior systemic treatment for
metastatic MCC. Prior chemotherapy treatment in the adjuvant setting (no clinically
detectable disease; no metastatic disease) is allowable if the end of treatment
occurred at least 6 months prior to study start)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- Disease must be measurable with at least 1 uni-dimensional measurable lesion by RECIST
Version 1.1 (including skin lesions)

- Adequate hematological, hepatic and renal function (renal function considered adequate
as per protocol definition)

- Highly effective contraception for both male and female participants, if the risk of
conception exists

- Fresh Biopsy or Archival Tumor Tissue

- Estimated life expectancy of more than 12 weeks
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participation in another interventional clinical trial within the past 30 days
(participation in observational studies is permitted)

- Concurrent treatment with a non permitted drug

- Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune
checkpoints) such as antiprogrammed death 1 (PD-1), anti-PD-L1, or anticytotoxic
T-lymphocyte antigen-4 (CTLA-4) antibody; for Part B, the Investigator must consult
with the Medical Monitor and consider other co-regulatory targets such as 4-1BB

- Concurrent anticancer treatment (for example, cytoreductive therapy, radiotherapy
[with the exception of palliative bone-directed radiotherapy, or radiotherapy
administered on non-target superficial lesions], immune therapy, or cytokine therapy
except for erythropoietin). Radiotherapy administered to superficial lesions is not
allowed if such lesions are considered target lesions in the efficacy evaluation or
may influence the efficacy evaluation of the investigational agent

- Major surgery for any reason, except diagnostic biopsy, within 4 weeks and/or if the
participant has not fully recovered from the surgery within 4 weeks

- Concurrent systemic therapy with steroids or other immunosuppressive agents, or use of
any investigational drug within 28 days before the start of trial treatment.
Short-term administration of systemic steroids (that is, for allergic reactions or the
management of immune-related adverse events [irAE]) while on study is allowed. Also,
participants requiring hormone replacement with corticosteroids for adrenal
insufficiency are eligible if the steroids are administered only for the purpose of
hormonal replacement and at doses <= 10 mg or equivalent prednisone per day. Note:
Participants receiving bisphosphonate or denosumab are eligible.

- Participants with active central nervous system (CNS) metastases are excluded.
Participants with a history of treated CNS metastases (by surgery or radiation
therapy) are not eligible unless they have fully recovered from treatment,
demonstrated no progression for at least 2 months, and do not require continued
steroid therapy

- Previous malignant disease (other than MCC) within the last 5 years with the exception
of basal or squamous cell carcinoma of the skin and for Part A cervical carcinoma in
situ or for Part B carcinoma in situ (skin, bladder, cervical, colorectal, breast or
low grade prostatic intraepithelial neoplasia or Grade 1 prostate cancer)

- Prior organ transplantation, including allogeneic stem-cell transplantation

- Part A: Known history of testing positive for HIV or known acquired immunodeficiency
syndrome (AIDS) or any positive test for hepatitis B virus or hepatitis C virus
indicating acute or chronic infection. For Part B, known history of testing positive
for HIV or known AIDS in consultation with the Medical Monitor or HBV or HCV infection
at screening (positive HBV surface antigen or HCV RNA if anti- HCV antibody screening
test positive).

- Active or history of any autoimmune disease (except for participants with vitiligo) or
immunodeficiencies that required treatment with systemic immunosuppressive drugs

- Known severe hypersensitivity reactions to monoclonal antibodies (Grade greater than
or equal to (>=) 3 NCI CTCAE v 4.0), any history of anaphylaxis, or uncontrolled
asthma (that is, 3 or more features of partially controlled asthma)

- Persisting toxicity related to prior therapy Grade > 1 NCI-CTCAE v 4.0; however,
sensory neuropathy Grade <= 2 is acceptable 14. Pregnancy or lactation

- Known alcohol or drug abuse

- Clinically significant (that is, active) cardiovascular disease: cerebral vascular
accident / stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months
prior to enrollment), unstable angina, congestive heart failure (New York Heart
Association Classification Class >= II), or serious cardiac arrhythmia requiring
medication

- All other significant diseases (for example, inflammatory bowel disease), which, in
the opinion of the Investigator, might impair the participant's tolerance of trial
treatment

- Any psychiatric condition that would prohibit the understanding or rendering of
informed consent

- Legal incapacity or limited legal capacity

- Non oncology vaccine therapies for prevention of infectious disease (for example,
seasonal flu vaccine, human papilloma virus vaccine) within 4 weeks of trial drug
administration. Vaccination while on trial is also prohibited except for
administration of inactivated vaccines (for example, inactivated seasonal influenza
vaccine)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Tasman Oncology Research Ltd - Southport
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [6] 0 0
St John of God Subiaco Hospital - Perth
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
- Southport
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3128 - East Melbourne
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
France
State/province [12] 0 0
Alpes Maritimes
Country [13] 0 0
France
State/province [13] 0 0
Bouches-du-Rhône
Country [14] 0 0
France
State/province [14] 0 0
Doubs
Country [15] 0 0
France
State/province [15] 0 0
Hauts De Seine
Country [16] 0 0
France
State/province [16] 0 0
Loire Atlantique
Country [17] 0 0
France
State/province [17] 0 0
Nord
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
France
State/province [19] 0 0
Rhone
Country [20] 0 0
France
State/province [20] 0 0
Val De Marne
Country [21] 0 0
France
State/province [21] 0 0
Bordeaux
Country [22] 0 0
France
State/province [22] 0 0
Chambray Les Tours
Country [23] 0 0
France
State/province [23] 0 0
Dijon
Country [24] 0 0
France
State/province [24] 0 0
Grenoble
Country [25] 0 0
France
State/province [25] 0 0
Limoges
Country [26] 0 0
Germany
State/province [26] 0 0
Baden Wuerttemberg
Country [27] 0 0
Germany
State/province [27] 0 0
Hessen
Country [28] 0 0
Germany
State/province [28] 0 0
Nordrhein Westfalen
Country [29] 0 0
Germany
State/province [29] 0 0
Sachsen
Country [30] 0 0
Germany
State/province [30] 0 0
Schleswig Holstein
Country [31] 0 0
Germany
State/province [31] 0 0
Thueringen
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Italy
State/province [33] 0 0
Torino
Country [34] 0 0
Italy
State/province [34] 0 0
Milano
Country [35] 0 0
Italy
State/province [35] 0 0
Napoli
Country [36] 0 0
Italy
State/province [36] 0 0
Padova
Country [37] 0 0
Italy
State/province [37] 0 0
Perugia
Country [38] 0 0
Italy
State/province [38] 0 0
Reggio Emilia
Country [39] 0 0
Italy
State/province [39] 0 0
Roma
Country [40] 0 0
Italy
State/province [40] 0 0
Siena
Country [41] 0 0
Japan
State/province [41] 0 0
Shizuoka-Ken
Country [42] 0 0
Japan
State/province [42] 0 0
Tokyo-To
Country [43] 0 0
Spain
State/province [43] 0 0
Barcelona
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid
Country [45] 0 0
Spain
State/province [45] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EMD Serono Research & Development Institute, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the
efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC).
Trial website
https://clinicaltrials.gov/show/NCT02155647
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications