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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003711-21 | EudraCT Number | ||
| 2024-514274-46-00 | EU Trial (CTIS) Number | ||
| jRCT2080224625 | Other Identifier | JRCT (Japan) | |
| JapicCTI-194697 | Other Identifier | JAPIC (Japan) |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avelumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab | Drug | Participants entering this roll over study will receive avelumab as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2 weeks until progressive disease, according to respective parent studies (EMR100070-001, EMR100070-002, EMR100070-004 and EMR100070-008). |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events | From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From baseline up to 5 years | |
| Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | From baseline up to 5 years |
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Inclusion Criteria:
Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of EMD Serono Research & Development Institute, Inc. / Merck KGaA, Darmstadt, Germany
Participants currently enrolled in an avelumab parent study and are on active treatment with avelumab or in long-term survival follow-up after treatment
Participants on active treatment must agree to continue to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists
Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| Highlands Oncology Group |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports 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 bit.ly/IPD21
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.
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|
|
| Duration of Response (DOR) Assessed From Complete Response (CR) or Partial Response (PR) | From baseline up to 5 years |
| Fayetteville |
| Arkansas |
| 72703 |
| United States |
| University of California Davis Health System - Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| Providence Medical Foundation | Santa Rosa | California | 95403 | United States |
| St Joseph Heritage Healthcare | Santa Rosa | California | 95403 | United States |
| Norwalk Hospital - The Whittingham Cancer Center | Norwalk | Connecticut | 06850 | United States |
| Hematology - Oncology Associates of the Treasure Coast - Hematology-Oncology Associates of Treasure Coast | Port Saint Lucie | Florida | 34952 | United States |
| Northwest Georgia Oncology Centers | Marietta | Georgia | 30060 | United States |
| Maryland Oncology Hematology, P.A. | Rockville | Maryland | 20850 | United States |
| Michigan State University | Lansing | Michigan | 48910 | United States |
| Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | United States |
| Kansas City Research Institute, LLC - Phase I Unit | Kansas City | Missouri | 64131 | United States |
| University of Cincinnati - PARENT | Cincinnati | Ohio | 45229 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| Oncology/Hematology Care Clinical Trials, LLC | Cincinnati | Ohio | 45242 | United States |
| OSU - James Comprehensive Cancer Center | Columbus | Ohio | 43210-1228 | United States |
| Oregon Health & Science University | Portland | Oregon | 97201 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Greenville Hospital System University Medical Center (ITOR) - Upstate Affiliate Organization | Greenville | South Carolina | 29605 | United States |
| The West Clinic | Germantown | Tennessee | 38138 | United States |
| SCRI - Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8857 | United States |
| Oncology Consultants, P.A. | Houston | Texas | 77030 | United States |
| Henry Ford Hospital | San Antonio | Texas | 78229 | United States |
| University of Vermont Medical Center - Fletcher Allen Gastroenterology | Burlington | Vermont | 05401 | United States |
| Instituto Alexander Fleming | Ciudad Autonoma Buenos Aires | Argentina |
| Clínica Universitaria Privada Reina Fabiola | Córdoba | Argentina |
| Ballarat Health Services | Ballarat | Australia |
| Monash Medical Centre Clayton | Clayton | Australia |
| Centre Hospitalier de l'Ardenne - Pharmacie | Libramont | Belgium |
| Clinique CHC MontLégia | Liège | Belgium |
| Hospital de Câncer de Barretos - Fundação Pio XII | Barretos | Brazil |
| MHAT for women's health - Nadezhda, OOD | Sofia | Bulgaria |
| Nemocnice Rudolfa a Stefanie Benesov a.s. nemocnice Stredoceskeho kraje - parent | Benešov | Czechia |
| Masarykuv onkologicky ustav - 300176866 Parent | Brno | Czechia |
| CHU Besançon - Hôpital Jean Minjoz - Service d'oncologie Medicale | Besançon | France |
| Centre Oscar Lambret - Service d'Oncologie medicale | Lille | France |
| ICO - Site Paul Papin - service d'oncologie medicale | Nantes | France |
| ICO - Site René Gauducheau - Service d'Oncologie medicale | Nantes | France |
| Centre Antoine Lacassagne - Service d'Hématologie Oncologie | Nice | France |
| Institut Curie - site de Paris - Service d'Oncologie Médicale | Paris | France |
| CHU Bordeaux - Service d'Oncologie Médicale | Pessac | France |
| Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Unité d'Explorations Fonctionnelles Respiratoires | Pessac | France |
| CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale | Poitiers | France |
| Centre Paul Strauss - Service de Médecine Oncologique | Strasbourg | France |
| Hopital Larrey - Service de Pneumologie et Oncologie Thoracique | Toulouse | France |
| Universitaetsklinikum Essen - Westdeutsches Tumorzentrum | Essen | Germany |
| Petz Aladar Egyetemi Oktato Korhaz - Pulmonologiai Osztaly | Győr | Hungary |
| Zala Varmegyei Szent Rafael Korhaz - Pulmonologiai Osztaly | Zalaegerszeg | Hungary |
| Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento Oncologia | Naples | Italy |
| IOV - Istituto Oncologico Veneto IRCCS | Padova | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica | Roma | Italy |
| Istituto Nazionale Tumori Regina Elena IRCCS - UOC Oncologia Medica A | Roma | Italy |
| Istituto Clinico Humanitas - U.O. di Oncologia Medica ed Ematologia | Rozzano | Italy |
| National Cancer Center Hospital (NCCH) | Chūōku | Japan |
| National Cancer Center Hospital - Dept of Gastrointestinal Oncology | Chūōku | Japan |
| Osaka Habikino Medical Center - Dept of Pulmonary Oncology | Habikino-shi | Japan |
| Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine | Kōtoku | Japan |
| Kurume University Hospital - Dept of Lung Cancer Center | Kurume-shi | Japan |
| Osaka City General Hospital - Dept of Clinical Oncology | Osaka | Japan |
| Tohoku University Hospital | Sendai | Japan |
| Osaka University Hospital - Dept of Gastrointestinal Surgery | Suita-shi | Japan |
| Health Pharma Professional Research S.A. de C.V. | México | Mexico |
| Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy - Dept of Lungs and Chest Oncology | Warsaw | Poland |
| Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca - Sectia Radioterapie III | Cluj-Napoca | Romania |
| S.C Radiotherapy Center Cluj S.R.L - Parent | Comuna Floresti | Romania |
| Institutul Regional de Oncologie Iasi - Sectia Oncologie Medicala | Iași | Romania |
| Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea - Centrul Oncologie Medicala | Oradea | Romania |
| S.C Oncomed S.R.L - Specialitatea Oncologie Medicala | Timișoara | Romania |
| RBIH "Kursk regional clinical oncology dispensary" of Kursk Region Healthcare Committee | Kursk | Russia |
| SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary" | Novosibirsk | Russia |
| BHI of Omsk region "Clinical Oncology Dispensary" - Building #2 | Omsk | Russia |
| FSBI "National Medical Research Center for Oncology n.a. N.N. Petrov" of the MoH of the RF - Parent | Saint Petersburg | Russia |
| LLC "Medical Technologies" - Parent | Saint Petersburg | Russia |
| Pavlov First Saint Petersburg State Medical University - PARENT | Saint Petersburg | Russia |
| Chungbuk National University Hospital | Cheongju-si | South Korea |
| Chonnam National University Hwasun Hospital | Daejeon | South Korea |
| National Cancer Center | Goyang | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| Hospital de la Santa Creu i Sant Pau - Dept of Oncology | Barcelona | Spain |
| Hospital Universitari Vall d'Hebron - Oncology Dept. | Barcelona | Spain |
| Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica | Madrid | Spain |
| Hospital de Mataro - Servicio de Oncologia Medica | Mataró | Spain |
| Songklanagarind Hospital - Department of Medicine | Songkhla | Thailand |
| Adana City Hospital - Parent Account | Adana | Turkey (Türkiye) |
| Ankara University Medical Faculty - Medical Oncology | Ankara | Turkey (Türkiye) |
| Hacettepe University Medical Faculty - Oncology | Ankara | Turkey (Türkiye) |
| Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology | Istanbul | Turkey (Türkiye) |
| Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty - Medical Oncology | Istanbul | Turkey (Türkiye) |
| Medipol University Medical Faculty - Parent | Istanbul | Turkey (Türkiye) |
| Ege University Medical Faculty - PARENT | Izmir | Turkey (Türkiye) |
| Mersin University Medical Faculty - Medical Oncology | Mersin | Turkey (Türkiye) |
| CNE KHERSON REG ONCOLOGICAL DISPENSARY OF KHERSON RC - Day Hosp of Polycl with Outpatient Chemoth Room | Kherson | Ukraine |
| BP Medical | Vinnytsia | 21029 | Ukraine |
| Podilskyi Regional Oncological Center - Dept of Chemotherapy | Vinnytsia | Ukraine |
| Sarah Cannon Research Institute UK | London | United Kingdom |
| Mount Vernon Cancer Centre | Northwood | United Kingdom |
| Derriford Hospital - Dept of Oncology Clinical Trials | Plymouth | United Kingdom |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002292 | Carcinoma, Renal Cell |
| D002295 | Carcinoma, Transitional Cell |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C000609138 | avelumab |
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