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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003669-36 | EudraCT Number | ||
| 2023-510139-12-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany; Gilead Sciences; Nektar Therapeutics | UNKNOWN |
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The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Avelumab | Experimental |
| |
| Group B: Avelumab + Sacituzumab Govitecan | Experimental |
| |
| Group C: Avelumab + M6223 | Experimental |
| |
| Group D: Avelumab + NKTR-255 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab | Drug | Participants will receive avelumab intravenous infusion at a dose of 800 milligrams (mg) once every 2 weeks (Q2W) until unacceptable toxicity, withdraw consent or initiation of a new treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator | Time from randomization of study drug until first documentation of progressive disease (PD) or death, assessed approximately up to 51 months | |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, and AEs of Special Interest (AESIs) as per Qualitative Toxicity Scale [National Cancer Institute-Common Terminology Criteria for Adverse Events 5.0] | From Randomization up to the last safety follow-up visit at approximately up to 51 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time from randomization of study drug until death, assessed approximately up to 51 months | |
| Objective Response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator | Time from randomization of study drug up to 51 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beacon Cancer Care | Coeur d'Alene | Idaho | 83814 | United States | ||
| University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39929671 | Derived | Naing A, McKean M, Tolcher A, Victor A, Hu P, Gao W, Nogueira Filho MAF, Kitzing T, Gleicher S, Holland D, Richter E, Tadjalli-Mehr K, Siu LL. TIGIT inhibitor M6223 as monotherapy or in combination with bintrafusp alfa in patients with advanced solid tumors: a first-in-human, phase 1, dose-escalation trial. J Immunother Cancer. 2025 Feb 10;13(2):e010584. doi: 10.1136/jitc-2024-010584. | |
| 37671748 |
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | 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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| Sacituzumab Govitecan | Drug | Participants will receive sacituzumab govitecan intravenous infusion at dose of 10 milligrams per kilogram (mg/kg) of body weight once a week (Q1W) on Day 1 and 8 of 21-day treatment cycles, in combination with avelumab 800 mg Q2W, until unacceptable toxicity, withdraw consent or initiation of a new treatment. |
|
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| M6223 | Drug | Participants will receive M6223 (anti-T cell-immuno-receptor with Ig and ITM domains [anti-TIGIT]) intravenous infusion at dose of 1600 mg Q2W in combination with avelumab 800 mg Q2W, until unacceptable toxicity, withdraw consent or initiation of a new treatment. |
|
| NKTR-255 | Drug | Participants will receive NKTR-255 intravenous infusion at a dose of 3 micrograms per kilogram body weight (mcg/kg) once every 4 weeks (Q4W) in combination with avelumab 800 mg Q2W, until unacceptable toxicity, withdraw consent or initiation of a new treatment. |
|
| Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 Assessed by Investigator | Time from first documented objective response to PD or death due to any cause, assessed approximately up to 51 months |
| Pharmacokinetic Serum Concentration of Avelumab, M6223, Sacituzumab govitecan and NKTR255 | Pre-dose up to safety follow up, assessed approximately up to maximum 51 months |
| Number of Participants with Positive Anti-Drug Antibody (ADA) of Avelumab, M6223, Sacituzumab govitecan and NKTR-255 | Baseline up to 51 months |
| Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores | Baseline, Week 13 |
| Kansas City |
| Kansas |
| 66205 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21287-7049 | United States |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center | Kansas City | Missouri | 66204 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Multicare Health System Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| University of Wisconsin Cancer Center | Madison | Wisconsin | 53706 | United States |
| Flinders Medical Centre | Bedford Park | Australia |
| Sunshine Hospital - PARENT | Footscray | Australia |
| Ashford Cancer Centre Research | Kurralta Park | Australia |
| Liverpool Hospital - PARENT | Liverpool | Australia |
| Calvary Mater Newcastle - PARENT | Newcastle | Australia |
| Tasman Oncology Research Ltd - Oncology | Southport | Australia |
| Macquarie University Hospital - PARENT | Sydney | Australia |
| The Kinghorn Can Cen | Westmead | Australia |
| ZNA Middelheim - Middelheim - account 2 | Antwerp | Belgium |
| AZ Klina - PARENT | Brasschaat | Belgium |
| Institut Jules Bordet - Medical Oncology | Brussels | Belgium |
| Universitair Ziekenhuis Gent - Medical Oncology | Ghent | Belgium |
| AZ Groeninge - Campus Kennedylaan - account 2 | Kortrijk | Belgium |
| Centre Hospitalier de l'Ardenne - PARENT | Libramont | Belgium |
| CHU de Liège - PARENT | Liège | Belgium |
| Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie | Wuerzburg | Belgium |
| William Osler Health System - Brampton Civic Hospital | Brampton | Canada |
| CISSS de la Monteregie-Centre - Hospital Charles Le Moyne | Greenfield Park | Canada |
| CHUM Centre de Recherche | Montreal | Canada |
| The Ottawa Hospital Cancer Centre | Ottawa | Canada |
| Hôpital Foch - Service d'Oncologie Médicale | Suresnes | Hauts De Seine | 92151 | France |
| ICO - Site Paul Papin - service d'oncologie medicale | Angers | France |
| Institut Bergonié - Service d'Oncologie Médicale | Bordeaux | France |
| Centre François Baclesse - Pathologies Gynecologiques | Caen | France |
| Hôpital Henri Mondor - Service d'Oncologie Médicale | Créteil | France |
| Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médical | Le Mans | France |
| Centre Leon Berard - Service d'Oncologie Medicale | Lyon | France |
| Hôpital de la Timone - service d'urologie | Marseille | France |
| Hopital Caremeau - Service Hématologie Clinique/Oncologie Médicale | Nîmes | France |
| Hôpital Cochin - Hematologie et Oncologie Médicale | Paris | France |
| CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale | Poitiers | France |
| CRLCC Eugene Marquis - Service d'Oncologie médicale | Rennes | France |
| ICO - Site René Gauducheau - Service d'Oncologie medicale | Saint-Herblain | France |
| Clinique Sainte-Anne - Service d'Oncologie Médicale | Strasbourg | France |
| Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale | Strasbourg | France |
| Kliniken Maria Hilf GmbH - Klinik fuer Urologie | Muenchen | North Rhine-Westphalia | 41063 | Germany |
| Universitaetsklinikum Halle (Saale) - Universitaetsklinik und Poliklinik fuer Urologie | Halle | Saxony-Anhalt | 0044384 | Germany |
| Universitaetsklinikum Essen - Westdeutsches Tumorzentrum | Essen | Germany |
| Universitaetsklinikum Frankfurt Goethe-Universitaet - Urologie und Kinderurologie2 | Frankfurt | Germany |
| Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie | Halle | Germany |
| Kliniken Maria Hilf GmbH - Klinik fuer Urologie | Mönchengladbach | Germany |
| Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie | Münster | Germany |
| Universitaetsklinikum Tuebingen - Klinik fuer Urologie | Tübingen | Germany |
| Athens Medical Center | Athens | Greece |
| General Hospital of Athens "Alexandra" | Athens | Greece |
| University General Hospital "Attikon" | Athens | Greece |
| Euromedica General Clinic of Thessaloniki | Thessaloniki | Greece |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica | Bologna | Italy |
| Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica | Florence | Italy |
| IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST - Oncologia | Forlì | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Oncologia Medica Genitourinaria | Milan | Italy |
| Ospedale San Raffaele - U.O. di Oncologia Medica | Milan | Italy |
| Humanitas Istituto Clinico Catanese - Oncologia Medica | Misterbianco | Italy |
| Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A | Naples | Italy |
| Istituto Nazionale Tumori Regina Elena IRCCS - Urologia | Naples | Italy |
| IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1 | Padova | Italy |
| Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia | Pisa | Italy |
| Ospedale Santa Maria delle Croci | Ravenna | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica | Rome | Italy |
| IRCCS Ospedale Casa Sollievo della Sofferenza - Dipartimento di Oncologia Medica | San Giovanni Rotondo | Italy |
| Azienda Ospedaliera S. Maria Di Terni - S.C. Oncologia Medica | Terni | Italy |
| Chungnam National University Hospital - Department of Internal Medicine (Rheumatology) | Daejeon | South Korea |
| National Cancer Center | Gyeonggi-do | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| Hospital Infanta Cristina - Unidad de Fase I | Badajoz | Spain |
| Hospital Clinic de Barcelona - Servicio de Oncologia | Barcelona | Spain |
| Hospital de la Santa Creu i Sant Pau - Dept of Oncology | Barcelona | Spain |
| Hospital del Mar - Servicio de Oncologia | Barcelona | Spain |
| Hospital Universitario Virgen del Rocio - Oncology Service | Barcelona | Spain |
| Hospital Universitario Reina Sofia - Dept of Oncology | Córdoba | Spain |
| Hospital General Universitario de Elche - Servicio de Oncologia | Elche | Spain |
| Hospital Universitario Lucus Augusti - Oncology | Lugo | Spain |
| Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica | Madrid | Spain |
| ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology Dept | Manresa | Spain |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| Chi Mei Hospital, Liouying | Tainan | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Chang Gung Memorial Hospital,Linkou | Taoyuan | Taiwan |
| Barts Hospital - Dept of Medical Oncology | London | Greater London | 0024514 | United Kingdom |
| The Christie Hospital - Dept of Oncology | Manchester | United Kingdom |
| Royal Preston Hospital - Rosemere Cancer Centre | Preston | United Kingdom |
| Derived |
| Hoffman-Censits J, Grivas P, Powles T, Hawley J, Tyroller K, Seeberger S, Guenther S, Jacob N, Mehr KT, Hahn NM. The JAVELIN Bladder Medley trial: avelumab-based combinations as first-line maintenance in advanced urothelial carcinoma. Future Oncol. 2024 Feb;20(4):179-190. doi: 10.2217/fon-2023-0492. Epub 2023 Sep 6. |
| US Medical Information website, Medical Resources | View source |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 19, 2026 |
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000609138 | avelumab |
| C000608132 | sacituzumab govitecan |
| C000720852 | NKTR-255 |
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