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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000445-79 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Avelumab | Experimental | 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. |
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| Part B: Avelumab | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 113 weeks |
| 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. | Up to 161 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90024 | United States | ||
| The Angeles Clinic and Research Institute - West LA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27592805 | Result | Kaufman HL, Russell J, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbe C, Linette GP, Milella M, Brownell I, Lewis KD, Lorch JH, Chin K, Mahnke L, von Heydebreck A, Cuillerot JM, Nghiem P. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385. doi: 10.1016/S1470-2045(16)30364-3. Epub 2016 Sep 1. | |
| 29347993 |
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
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Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
A total of 88 participants were enrolled in Part A of the study and a total of 116 participants were enrolled in Part B of the study. Participants enrolled in Part A were not eligible for enrollment in Part B.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2018 | Jul 7, 2020 |
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| Up to 325 weeks |
| 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. | Up to 325 weeks |
| 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. | Up to 325 weeks |
| 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. | Up to 325 weeks |
| 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. | Up to 325 weeks |
| 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. | Up to 325 weeks |
| 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. | Up to 87 weeks (Data reported are per pre-specified interim analysis with a data cut-off date of 3 Mar 2016) |
| 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. | Time from first administration of trial treatment until death (Up to 325 weeks) |
| 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. | At Month 6 and 12 |
| 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. | Up to 80 weeks |
| Part A: Serum Concentration at End of Infusion (CEOI) of Avelumab | Serum concentration at end of infusion (CEOI) of Avelumab is reported. | Day 1, 43, 85, 169, 253, 337 and 421 |
| Part A: Minimum Serum Post-dose (Ctrough) Concentration of Aveluamb | Minimum serum post-dose (Ctrough) concentration of avelumab was reported. | Day 15, 29, 43, 57, 71, 85, 99, 169, 211, 253, 337 and 421 |
| 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). | Up to 161 weeks (Data reported are per pre-specified interim analysis with a data cut-off date of 2 May 2019) |
| 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). | Time from first administration of trial treatment until death (Up to 396 weeks) |
| 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. | Up to 396 weeks |
| 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. | Up to 396 weeks |
| 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. | Up to 396 weeks |
| 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. | Up to 396 weeks |
| 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. | At Month 6 and 12 |
| 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. | Up to 161 weeks |
| Part B: Serum Concentration at End of Infusion (CEOI) of Avelumab | Serum concentration at end of infusion (CEOI) of Avelumab is reported. | At Day 1, 43 and 169 |
| Part B: Minimum Serum Post-dose (Ctrough) Concentration of Aveluamb | Minimum serum post-dose (Ctrough) concentration of avelumab was reported. | Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505, Day 589, Day 673 |
| Los Angeles |
| California |
| 90025 |
| United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| H. Lee Moffitt Cancer Center and Research Institute, Inc | Tampa | Florida | 33612 | United States |
| National Cancer Institute | Bethesda | Maryland | 20892 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215-5418 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901-1914 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Peggy & Charles Stephenson Oklahoma Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Washington - Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Port Macquarie Base Hospital | Port Macquarie | New South Wales | 2444 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Tasman Oncology Research Ltd | Southport | Queensland | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Peter MacCallum Cancer Centre | East Melbourne | Victoria | 3128 | Australia |
| St John of God Subiaco Hospital | Perth | Western Australia | 6000 | Australia |
| CHU Nice - Hopital de l Archet 2 | Nice | Alpes Maritimes | 06202 | France |
| Hôpital de la Timone | Marseille | Bouches-du-Rhône | 13385 | France |
| CHU Besançon - Hôpital Jean Minjoz | Besançon | Doubs | 25030 | France |
| CHU Nantes - Hôtel Dieu | Nantes | Loire Atlantique | 44093 | France |
| Hopital Claude Huriez - CHU Lille | Lille | Nord | 59037 | France |
| Hôpital Saint-Louis | Paris | Paris | 75475 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | Rhone | 69495 | France |
| Institut Gustave Roussy | Villejuif | Val De Marne | 94805 | France |
| Groupe Hospitalier Saint André - Hôpital Saint André | Bordeaux | France |
| Hôpital Ambroise Paré - Boulogne-Billancourt | Boulogne-Billancourt | France |
| CHU Tours - Hôpital Trousseau | Chambray-lès-Tours | France |
| CHU de Dijon - Hopital du Bocage | Dijon | France |
| CHU de Grenoble - Hôpital A Michallon | Grenoble | France |
| CHU de Limoges - Hôpital Dupuytren | Limoges | France |
| Universitaetsklinikum Heidelberg | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt am Main | Hesse | 60590 | Germany |
| St. Josef-Hospital Universitaetsklinikum | Bochum | North Rhine-Westphalia | 44791 | Germany |
| Universitaetsklinikum Koeln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitaetsklinikum Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| Fachklinik Hornheide | Münster | North Rhine-Westphalia | 48157 | Germany |
| Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden | Saxony | 01307 | Germany |
| Universitaetsklinikum Schleswig-Holstein - Klinik fuer Allgemeine Innere Medizin | Kiel | Schleswig-Holstein | 24105 | Germany |
| Universitaetsklinikum Schleswig Holstein - Campus Luebeck | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Helios Klinikum Erfurt | Erfurt | Thuringia | 99089 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Berlin | 10117 | Germany |
| Fondazione del Piemonte per l'Oncologia IRCC Candiolo | Candiolo | Torino | 10060 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| IEO Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Istituto Nazionale Tumori Fondazione G.Pascale | Naples | 80131 | Italy |
| IOV - Istituto Oncologico Veneto IRCCS | Padova | 35128 | Italy |
| Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia | Perugia | 06156 | Italy |
| Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia | Reggio Emilia | 42100 | Italy |
| Istituto Nazionale Tumori Regina Elena IRCCS | Roma | 00144 | Italy |
| A.O.U. Senese Policlinico Santa Maria alle Scotte | Siena | 53100 | Italy |
| Shizuoka Cancer Center | Shizuoka | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital | Chūōku | Japan |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Result |
| Kaufman HL, Russell JS, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbe C, Milella M, Brownell I, Lewis KD, Lorch JH, von Heydebreck A, Hennessy M, Nghiem P. Updated efficacy of avelumab in patients with previously treated metastatic Merkel cell carcinoma after >/=1 year of follow-up: JAVELIN Merkel 200, a phase 2 clinical trial. J Immunother Cancer. 2018 Jan 19;6(1):7. doi: 10.1186/s40425-017-0310-x. |
| 29566106 | Result | D'Angelo SP, Russell J, Lebbe C, Chmielowski B, Gambichler T, Grob JJ, Kiecker F, Rabinowits G, Terheyden P, Zwiener I, Bajars M, Hennessy M, Kaufman HL. Efficacy and Safety of First-line Avelumab Treatment in Patients With Stage IV Metastatic Merkel Cell Carcinoma: A Preplanned Interim Analysis of a Clinical Trial. JAMA Oncol. 2018 Sep 1;4(9):e180077. doi: 10.1001/jamaoncol.2018.0077. Epub 2018 Sep 13. |
| 32414862 | Result | D'Angelo SP, Bhatia S, Brohl AS, Hamid O, Mehnert JM, Terheyden P, Shih KC, Brownell I, Lebbe C, Lewis KD, Linette GP, Milella M, Georges S, Shah P, Ellers-Lenz B, Bajars M, Guzel G, Nghiem PT. Avelumab in patients with previously treated metastatic Merkel cell carcinoma: long-term data and biomarker analyses from the single-arm phase 2 JAVELIN Merkel 200 trial. J Immunother Cancer. 2020 May;8(1):e000674. doi: 10.1136/jitc-2020-000674. |
| 32472503 | Result | Lambert J, Marrel A, D'Angelo SP, Burgess MA, Chmielowski B, Fazio N, Gambichler T, Grob JJ, Lebbe C, Robert C, Russell J, Guzel G, Bharmal M. Patient Experiences with Avelumab in Treatment-Naive Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial. Patient. 2020 Aug;13(4):457-467. doi: 10.1007/s40271-020-00428-5. |
| 29512061 | Result | Kaufman HL, Dias Barbosa C, Guillemin I, Lambert J, Mahnke L, Bharmal M. Living with Merkel Cell Carcinoma (MCC): Development of a Conceptual Model of MCC Based on Patient Experiences. Patient. 2018 Aug;11(4):439-449. doi: 10.1007/s40271-018-0301-0. |
| 29273043 | Result | Bharmal M, Fofana F, Barbosa CD, Williams P, Mahnke L, Marrel A, Schlichting M. Psychometric properties of the FACT-M questionnaire in patients with Merkel cell carcinoma. Health Qual Life Outcomes. 2017 Dec 22;15(1):247. doi: 10.1186/s12955-017-0815-5. |
| 33219092 | Result | Kelly K, Manitz J, Patel MR, D'Angelo SP, Apolo AB, Rajan A, Kasturi V, Speit I, Bajars M, Warth J, Gulley JL. Efficacy and immune-related adverse event associations in avelumab-treated patients. J Immunother Cancer. 2020 Nov;8(2):e001427. doi: 10.1136/jitc-2020-001427. |
| 32938212 | Result | Bharmal M, Nolte S, Lebbe C, Mortier L, Brohl AS, Fazio N, Grob JJ, Pusceddu S, Hanna GJ, Hassel JC, Kiecker F, Ellers-Lenz B, Bajars M, Guzel G, Nghiem P, Hunger M, Schlichting M, Henry-Szatkowski M, D'Angelo SP. Health-related quality of life trajectory of treatment-naive patients with Merkel cell carcinoma receiving avelumab. Future Oncol. 2020 Sep;16(27):2089-2099. doi: 10.2217/fon-2020-0426. Epub 2020 Sep 17. |
| 34921021 | Derived | Grisic AM, Xiong W, Tanneau L, Jonsson S, Friberg LE, Karlsson MO, Dai H, Zheng J, Girard P, Khandelwal A. Model-Based Characterization of the Bidirectional Interaction Between Pharmacokinetics and Tumor Growth Dynamics in Patients with Metastatic Merkel Cell Carcinoma Treated with Avelumab. Clin Cancer Res. 2022 Apr 1;28(7):1363-1371. doi: 10.1158/1078-0432.CCR-21-2662. |
| 34301810 | Derived | D'Angelo SP, Lebbe C, Mortier L, Brohl AS, Fazio N, Grob JJ, Prinzi N, Hanna GJ, Hassel JC, Kiecker F, Georges S, Ellers-Lenz B, Shah P, Guzel G, Nghiem P. First-line avelumab in a cohort of 116 patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200): primary and biomarker analyses of a phase II study. J Immunother Cancer. 2021 Jul;9(7):e002646. doi: 10.1136/jitc-2021-002646. |
| 32430019 | Derived | Bharmal M, Nolte S, Henry-Szatkowski M, Hennessy M, Schlichting M. Update on the psychometric properties and minimal important difference (MID) thresholds of the FACT-M questionnaire for use in treatment-naive and previously treated patients with metastatic Merkel cell carcinoma. Health Qual Life Outcomes. 2020 May 19;18(1):145. doi: 10.1186/s12955-020-01402-3. |
| 32375680 | Derived | Bullement A, Willis A, Amin A, Schlichting M, Hatswell AJ, Bharmal M. Evaluation of survival extrapolation in immuno-oncology using multiple pre-planned data cuts: learnings to aid in model selection. BMC Med Res Methodol. 2020 May 6;20(1):103. doi: 10.1186/s12874-020-00997-x. |
| 31553054 | Derived | Novakovic AM, Wilkins JJ, Dai H, Wade JR, Neuteboom B, Brar S, Bello CL, Girard P, Khandelwal A. Changing Body Weight-Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma. Clin Pharmacol Ther. 2020 Mar;107(3):588-596. doi: 10.1002/cpt.1645. Epub 2019 Nov 18. |
| 29914528 | Derived | Bharmal M, Guillemin I, Marrel A, Arnould B, Lambert J, Hennessy M, Fofana F. How to address the challenges of evaluating treatment benefits-risks in rare diseases? A convergent mixed methods approach applied within a Merkel cell carcinoma phase 2 clinical trial. Orphanet J Rare Dis. 2018 Jun 18;13(1):95. doi: 10.1186/s13023-018-0835-1. |
| US Medical Information website, Medical Resources | View source |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 113 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | Full analysis set (FAS) included all participants who received at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 161 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Median | Full Range | Months | Up to 325 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment. | Posted | Median | Full Range | Months | Up to 325 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| 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 | 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. | Safety analysis set included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 325 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety analysis set included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 325 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety analysis set included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 325 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | Up to 325 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to 87 weeks (Data reported are per pre-specified interim analysis with a data cut-off date of 3 Mar 2016) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment. | Posted | Median | Full Range | months | Time from first administration of trial treatment until death (Up to 325 weeks) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment. | Posted | Number | Percentage of participants | At Month 6 and 12 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | Up to 80 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part A: Serum Concentration at End of Infusion (CEOI) of Avelumab | Serum concentration at end of infusion (CEOI) of Avelumab is reported. | Pharmacokinetic analysis set consists of all participants who received at least 1 dose of avelumab, and provide at least 1 measurable post-dose concentration. Here "Number analyzed" signifies those participants who were evaluable at specified timepoints | Posted | Mean | Standard Deviation | Micrograms per milliliter | Day 1, 43, 85, 169, 253, 337 and 421 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Part A: Minimum Serum Post-dose (Ctrough) Concentration of Aveluamb | Minimum serum post-dose (Ctrough) concentration of avelumab was reported. | Pharmacokinetic analysis set consists of all participants who received at least 1 dose of avelumab, and provide at least 1 measurable post-dose concentration. Here "Number analyzed" signifies those participants who were evaluable at specified timepoints | Posted | Mean | Standard Deviation | Micrograms per milliliter | Day 15, 29, 43, 57, 71, 85, 99, 169, 211, 253, 337 and 421 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Full Analysis Set included all participants who received at least 1 dose of study treatment. | Posted | Median | Full Range | Months | Up to 161 weeks (Data reported are per pre-specified interim analysis with a data cut-off date of 2 May 2019) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Full Analysis Set included all participants who received at least 1 dose of study treatment. | Posted | Median | Full Range | months | Time from first administration of trial treatment until death (Up to 396 weeks) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 396 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full 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. | Posted | Median | Full Range | Months | Up to 396 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set included all participants who received at least 1 dose of study treatment. | Posted | Median | Full Range | Months | Up to 396 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set included all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to 396 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full Analysis Set included all participants who received at least 1 dose of study treatment. | Posted | Number | Percentage of Participants | At Month 6 and 12 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full 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. | Posted | Count of Participants | Participants | Up to 161 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Serum Concentration at End of Infusion (CEOI) of Avelumab | Serum concentration at end of infusion (CEOI) of Avelumab is reported. | PK Analysis Set included all participants who received at least 1 dose of avelumab, and provided at least 1 measurable post-dose concentration. Here "Number analyzed" signifies those participants who were evaluable at specified time-point for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | At Day 1, 43 and 169 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Part B: Minimum Serum Post-dose (Ctrough) Concentration of Aveluamb | Minimum serum post-dose (Ctrough) concentration of avelumab was reported. | PK Analysis Set included all participants who received at least 1 dose of avelumab, and provided at least 1 measurable post-dose concentration. Here "Number analyzed" signifies those participants who were evaluable at specified time-point for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505, Day 589, Day 673 |
|
|
Part A: Up to 325 weeks; Part B: Up to 396 weeks
Adverse events were reported as per MedDRA v21.1 for Part A arm and MedDRA v22.0 for Part B.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 63 | 88 | 48 | 88 | 86 | 88 |
| EG001 | 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. | 72 | 116 | 58 | 116 | 114 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Eyelid function disorder | Eye disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Oesophageal spasm | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Radiation mucositis | Injury, poisoning and procedural complications | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Tumour compression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Autoimmune neuropathy | Nervous system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Paraneoplastic encephalomyelitis | Nervous system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Polyneuropathy in malignant disease | Nervous system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Epiglottic cyst | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Pleural thickening | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Vascular purpura | Skin and subcutaneous tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Autoimmune colitis | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Autoimmune disorder | Immune system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v21.1and 22.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 31, 2016 | Apr 24, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D015266 | Carcinoma, Merkel Cell |
| ID | Term |
|---|---|
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609138 | avelumab |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Non-complete Response/ Non-progressive Disease |
|
| Progressive Disease |
|
| Not evaluable |
|
|
| Participants |
|
|
| Participants |
|
|
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|---|---|
| Participants |
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| Participants |
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| Participants |
|
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| Participants |
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