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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521884-12-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.
The study consists of a:
Participants will be randomized 1:1 to receive either pumitamig in combination with the treatment of physician's choice (TPC) chemotherapy (Arm 1) or placebo in combination with TPC chemotherapy (Arm 2). Chemotherapy will be administered per standard of care. The randomization will be stratified based on the following factors:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Pumitamig + Treatment of Physician's Choice (TPC) Chemotherapy | Experimental | Participants will be administered with pumitamig (BNT327) plus chemotherapy regimen. |
|
| Arm 2: Placebo + TPC Chemotherapy | Placebo Comparator | Participants will be administered with matching placebo plus chemotherapy regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pumitamig | Drug | Solution for intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | PFS is defined as the time from randomization to first documented tumor progression (progressive disease assessed by BICR per response evaluation criteria in solid tumors [RECIST] v1.1), or death from any cause, whichever occurs first. | Up to approximately 32 months |
| Overall Survival (OS) | OS is defined as the time from randomization to death from any cause. | Up to approximately 49 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) as Assessed by BICR | ORR is defined as the percentage of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) as per RECIST v1.1 is assessed by BICR as best overall response. | Up to approximately 49 months |
| PFS |
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Inclusion Criteria:
Exclusion Criteria:
Have received any of the following therapies or drugs prior to the initiation of trial:
Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.
Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed.
Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BioNTech clinical trials patient information | Contact | +49 6131 9084 | 0 | patients@biontech.de |
| Name | Affiliation | Role |
|---|---|---|
| BioNTech Responsible Person | BioNTech SE | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Recruiting | Springdale | Arkansas | 72762 | United States | |
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| Nab-paclitaxel/Paclitaxel | Drug | IV infusion |
|
| Gemcitabine | Drug | IV infusion |
|
| Carboplatin | Drug | IV infusion |
|
| Eribulin | Drug | IV infusion |
|
| Matching placebo | Drug | IV infusion |
|
PFS is defined as the time from randomization to first documented tumor progression (progressive disease assessed by investigator per RECIST v1.1), or death from any cause, whichever occurs first. |
| Up to approximately 32 months |
| ORR | ORR is defined as the percentage of participants in whom a confirmed CR or confirmed PR (per RECIST v1.1) is observed as best overall response. | Up to approximately 49 months |
| Duration of Response (DOR) | DOR is defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first. | Up to approximately 49 months |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants in whom a confirmed CR or confirmed PR or stable disease (SD) (per RECIST v1.1, SD assessed at least 6 weeks after randomization) is observed as best overall response. | Up to approximately 32 months |
| PFS Rate as Assessed by BICR | At 6, 12, 18, and 24 months |
| PFS Rate as Assessed by Investigator | At 6, 12, 18, and 24 months |
| OS Rate | At 6, 12, 18, and 24 months |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) Including Grade Greater than or Equal to (>=) 3, Serious, and Fatal TEAEs by Relationship | TEAEs graded according to United Stated (US) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) | From the first dose of study treatment to the 90-days after last dose of study treatment (up to approximately 57 months) |
| Occurrence of Dose Interruption, Reduction, and Discontinuation of Trial Treatment due to TEAEs (including related TEAEs) | From the first dose of study treatment to the 90-days after last dose of study treatment (up to approximately 57 months) |
| Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 Questionnaire (QLQ-C30) Global Health Status/Quality-of-Life score (Items 29 and 30) | Global health status or quality of life (QoL) scale ranges in score from 0 to 100 with a high scale score representing a higher response level (for example, high score for global health status/QoL is high QoL: high score for symptom scale/item is high symptomatology or problems). | Baseline up to approximately 49 months |
| Change from Baseline in EORTC QLQ-C30 Physical Functioning | Physical functioning scale ranges in score from 0 to 100 with a high scale score representing a higher response level (for example, high score for functional scale is high/healthy level of functioning). | Baseline up to approximately 49 months |
| Change from Baseline in Arm Symptoms Scale of EORTC QLQ-Breast Cancer (BR)42 | Arm symptom scale ranges in score from 0 to 100 with a high scale score representing a higher level of symptoms or problems. | Baseline up to approximately 49 months |
| Change from Baseline in Breast Symptoms Scale of EORTC QLQ-BR42 | Breast symptom scale ranges in score from 0 to 100 with a high scale score representing a higher level of symptoms or problems. | Baseline up to approximately 49 months |
| Change from Baseline in Functional Assessment of Cancer Therapy-General Version (FACT-G) Overall Bother Item (FACT-GP5) | The single-item GP5, that is "I am bothered by side effects of treatment," is rated on a 5-point Likert scale (where 1=not at all and 5=very much) by the participants. A high scale score represents worse outcome. | Baseline up to approximately 49 months |
| University Of California - San Diego Moores Cancer Center |
| Recruiting |
| La Jolla |
| California |
| 92037 |
| United States |
| Cedar Sinai - Samuel Oschin Cancer Center | Recruiting | Los Angeles | California | 90048 | United States |
| Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center | Recruiting | Palo Alto | California | 94304-2201 | United States |
| Sacred Heart Medical Oncology Group | Recruiting | Pensacola | Florida | 32504 | United States |
| Cancer Care Specialists | Recruiting | Decatur | Illinois | 62526 | United States |
| Cancer Care Specialists of Illinois | Recruiting | O'Fallon | Illinois | 62269 | United States |
| Carle Foundation Hospital d/b/a Carle Cancer Center | Recruiting | Urbana | Illinois | 61801 | United States |
| University Medical Center, Inc. DBA University of Louisville Hospital/James Graham Brown Cancer Center | Recruiting | Louisville | Kentucky | 40202 | United States |
| New England Cancer Specialists | Recruiting | Westbrook | Maine | 04092 | United States |
| Saint Agnes Hospital, Clinical Research Center | Recruiting | Baltimore | Maryland | 21229 | United States |
| Lahey Hospital & Medical Center | Recruiting | Burlington | Massachusetts | 01805 | United States |
| Karmanos Cancer Center | Recruiting | Detroit | Michigan | 48201 | United States |
| Profound Research LLC at Michigan Hematology and Oncology Consultants | Recruiting | Royal Oak | Michigan | 48073 | United States |
| Saint Luke's Hospital of Kansas City | Recruiting | Kansas City | Missouri | 64111 | United States |
| Oncology Hematology West, PC dba Nebraska Cancer Specialist | Recruiting | Grand Island | Nebraska | 68803 | United States |
| Paradigm Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Recruiting | Omaha | Nebraska | 68310 | United States |
| Summit Medical Group PA | Recruiting | Florham Park | New Jersey | 07932 | United States |
| Paradigm New York Cancer and Blood Specialists | Recruiting | Bay Shore | New York | 11706 | United States |
| Paradigm New York Cancer and Blood Specialists | Recruiting | New York | New York | 10028 | United States |
| Paradigm New York Cancer and Blood Specialists | Recruiting | New York | New York | 10469 | United States |
| Paradigm New York Cancer and Blood Specialists | Recruiting | New York | New York | 11042 | United States |
| Paradigm New York Cancer and Blood Specialists | Recruiting | New York | New York | 11210 | United States |
| Paradigm New York Cancer and Blood Specialists | Recruiting | New York | New York | 11702 | United States |
| Paradigm New York Cancer and Blood Specialists | Recruiting | New York | New York | 11772 | United States |
| Paradigm New York Cancer and Blood Specialists | Recruiting | New York | New York | 11776 | United States |
| Paradigm New York Cancer and Blood Specialists | Recruiting | New York | New York | 11901 | United States |
| Rochester General Hospital Lipson Cancer Institute | Recruiting | Rochester | New York | 14621 | United States |
| Stony Brook University Medical Center | Recruiting | Stony Brook | New York | 11794 | United States |
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10461 | United States |
| Oncology Specialists of Charlotte Pa | Recruiting | Charlotte | North Carolina | 28204 | United States |
| Carolina Oncology Specialists | Recruiting | Charlotte | North Carolina | 28210 | United States |
| St Charles Bend Cancer Center | Recruiting | Bend | Oregon | 97701 | United States |
| St. Charles Cancer Center - Redmond | Recruiting | Redmond | Oregon | 97756 | United States |
| Oregon Oncology Specialists | Recruiting | Salem | Oregon | 97301 | United States |
| The West Clinic, P.C. dba West Cancer Center | Recruiting | Germantown | Tennessee | 38002 | United States |
| UT Southwestern Medical Center at Redbird | Recruiting | Dallas | Texas | 75237 | United States |
| University Of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
| UT Southwestern Moncrief Cancer Institute | Recruiting | Fort Worth | Texas | 76104 | United States |
| Oncology Consultants PA | Recruiting | Houston | Texas | 77024 | United States |
| Oncology Consultants PA | Recruiting | Houston | Texas | 77030 | United States |
| UT Southwestern Medical Center at Richardson/Plano | Recruiting | Richardson | Texas | 75080 | United States |
| Bon Secours Cancer Institute at Memorial Regional | Recruiting | Mechanicsville | Virginia | 23116 | United States |
| Bon Secours St. Francis Medical Center | Recruiting | Midlothian | Virginia | 23114 | United States |
| Bon Secours Cancer Institute at St. Mary's | Recruiting | Richmond | Virginia | 23226 | United States |
| Northwest Medical Specialties, PLLC | Recruiting | Tacoma | Washington | 98405 | United States |
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| St Vincent's Hospital - The Kinghorn Cancer Centre | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
| GenesisCare St Andrew's Precinct | Recruiting | Adelaide | South Australia | 50000 | Australia |
| Peninsula & South Eastern Hematology and Oncology Group | Recruiting | Frankston | Victoria | 3199 | Australia |
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
| Monash University - Monash Medical Centre (MMC) - Clayton | Recruiting | Melbourne | Victoria | 3168 | Australia |
| Westmead Hospital | Recruiting | Westmead | 2145 | Australia |
| Imeldaziekenhuis | Recruiting | Bonheiden | 2820 | Belgium |
| Universitair Ziekenhuis Brussel (AZ-VUB - Academisch Ziekenhuis der Vrije Universiteit Brussel) | Recruiting | Brussels | 1090 | Belgium |
| Grand hospital de Charleroi | Recruiting | Gilly | 6060 | Belgium |
| University Hospitals Leuven | Recruiting | Leuven | 3000 | Belgium |
| Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc | Recruiting | Woluwe-Saint-Lambert | 1200 | Belgium |
| Impar Servicos Hospitalares S/A - Hospital Brasilia | Recruiting | Brasília | 71681-603 | Brazil |
| Unidade de Pesquisa Clinica em Oncologia Ltda (UPCO) (Clinica Lacks) | Recruiting | Pelotas | 96020-080 | Brazil |
| Perola Centro de Pesquisa em Oncologia | Recruiting | São Paulo | 01317-001 | Brazil |
| Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita | Recruiting | Vitória | 29043-260 | Brazil |
| Changde First People's Hospital | Recruiting | Changde | 415003 | China |
| Shandong Cancer Hospital And Institute | Recruiting | Jinan | 250117 | China |
| Linyi Cancer Hospital | Recruiting | Linyi | 276001 | China |
| Jiangsu Peoples Hospital | Recruiting | Nanjing | 210029 | China |
| Fudan University - Shanghai Cancer Center (FUSCC) | Recruiting | Shanghai | 200032 | China |
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | 450052 | China |
| KOC Pardubickeho kraje Multiscan-Pardubicka nemocnice | Recruiting | Pardubice | 530 03 | Czechia |
| Fakultni Thomayerova nemocnice | Recruiting | Prague | 140 59 | Czechia |
| Fakultni nemocnice Motol a Homolka | Recruiting | Prague | 150 06 | Czechia |
| High Technology Hospital Medcenter LTD | Recruiting | Batumi | 6000 | Georgia |
| Multiprofile Clinic Consilium Medulla | Recruiting | Tbilisi | 0168 | Georgia |
| LLC Todua Clinic | Recruiting | Tbilisi | 112 | Georgia |
| Caucasus Medical Centre | Recruiting | Tbilisi | 186 | Georgia |
| Hämatologische-Onkologische Praxis Augsburg | Recruiting | Augsburg | 86150 | Germany |
| Onkologisch-Haematologische Schwerpunktpraxis | Recruiting | Bremen | 28209 | Germany |
| Praxis Fuer Interdisziplinaere Onkologie & Haematologie | Recruiting | Freiburg im Breisgau | 79106 | Germany |
| SRH Wald-Kliniken Gera GmbH | Recruiting | Gera | 07548 | Germany |
| Mammazentrum Hamburg - Brustklinik am Krankenhaus Jerusalem | Recruiting | Hamburg | 20357 | Germany |
| Institut fuer Versorgungsforschung in der Onkologie | Recruiting | Koblenz | 56068 | Germany |
| Klinikum Nürnberg Nord | Recruiting | Nuremberg | 90419 | Germany |
| Centro di Riferimento Oncologico (CRO) | Recruiting | Aviano | 33081 | Italy |
| Azienda Unità Sanitaria Locale 2 (USL2) Lucca | Recruiting | Lucca | 55100 | Italy |
| Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele) | Recruiting | Milan | 20132 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Recruiting | Milan | 20133 | Italy |
| IRCCS-Istituto Europeo di Oncologia | Recruiting | Milan | 20141 | Italy |
| ASST Monza-Azienda Ospedaliera San Gerardo | Recruiting | Monza | 20900 | Italy |
| Fondazione Policlinico Universitario Campus Bio-Medico | Recruiting | Roma | 00128 | Italy |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I | Recruiting | Torrette | 60126 | Italy |
| Chiba Cancer Center | Recruiting | Chiba | 260-8717 | Japan |
| Fukushima Medical University Hospital | Recruiting | Fukushima | 960-1295 | Japan |
| Gifu University Hospital | Recruiting | Gifu | 501-1112 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Recruiting | Hiroshima | 730-8518 | Japan |
| Hakuaikai Medical Corporation Sagara Hospital | Recruiting | Kagoshima | 892-0833 | Japan |
| Kumamoto University Hospital | Recruiting | Kumamoto | 860-8556 | Japan |
| Kyoto University Hospital | Recruiting | Kyoto | 606-8507 | Japan |
| National Hospital Organization Shikoku Cancer Center | Recruiting | Matsuyama | 791-0280 | Japan |
| Nagoya City University Hospital | Recruiting | Nagoya | 467-8602 | Japan |
| Kindai University Hospital | Recruiting | Sakai | 590-0197 | Japan |
| Tohoku University Hospital | Recruiting | Sendai | 980-8574 | Japan |
| National Center For Global Health And Medicine | Recruiting | Shinjuku-Ku | 162-8655 | Japan |
| Uniwersyteckie Centrum Kliniczne | Recruiting | Gdansk | 80-214 | Poland |
| IP Clinic Sp. z o.o. | Recruiting | Lodz | 90-752 | Poland |
| Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie - Państwowy Instytut Badawczy | Recruiting | Warsaw | 02-781 | Poland |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy | Recruiting | Warsaw | 04-141 | Poland |
| Soon Chun Hyang University Cheonan Hospital | Recruiting | Cheonan | 31151 | South Korea |
| Chungbuk National University Hospital | Recruiting | Cheongju-si | 28644 | South Korea |
| National Cancer Center | Recruiting | Goyang-si | 10408 | South Korea |
| Seoul National University Bundang Hospital (SNUBH) | Recruiting | Seongnam-si | 13620 | South Korea |
| Korea University Anam Hospital | Recruiting | Seoul | 2841 | South Korea |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 3722 | South Korea |
| Asan Medical Center (AMC) | Recruiting | Seoul | 5505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 6351 | South Korea |
| Ajou University Hospital | Recruiting | Suwon | 16499 | South Korea |
| Hospital Universitario de Badajoz | Recruiting | Badajoz | 6006 | Spain |
| Parc de Salut Mar - Hospital del Mar | Recruiting | Barcelona | 8003 | Spain |
| Institut Oncologic Rosell - Hospital General De Catalunya | Recruiting | Barcelona | 8195 | Spain |
| Hospital Universitario Reina Sofia | Recruiting | Córdoba | 14004 | Spain |
| IOB Institute of Oncology - Beata Maria Ana Hospital | Recruiting | Madrid | 28007 | Spain |
| Universidad de Navarra - Clinica Universidad de Navarra (CUN) | Recruiting | Madrid | 28027 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario Madrid Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC) | Recruiting | Madrid | 28050 | Spain |
| Hospital General Universitario Morales Meseguer | Recruiting | Murcia | 30008 | Spain |
| Hospital Universitario Virgen De La Arrixaca (Huva) | Recruiting | Murcia | 30120 | Spain |
| Universidad de Navarra - Clínica Universidad de Navarra (CUN) | Recruiting | Pamplona | 31008 | Spain |
| Hospital Universitari Parc Tauli | Recruiting | Sabadell | 8208 | Spain |
| Fundación Instituto Valenciano de Oncología | Recruiting | Valencia | 46009 | Spain |
| Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust | Recruiting | Brighton | BN2 5BE | United Kingdom |
| University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Haematology & Oncology Centre | Recruiting | Bristol | BS2 8ED | United Kingdom |
| Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital | Recruiting | Cottingham | HU16 5JQ | United Kingdom |
| Edinburgh Cancer Centre-Western General Hospital | Recruiting | Edinburgh | EH4 2LF | United Kingdom |
| St James's University Hospital - Leeds Teaching Hospitals NHS Trust | Recruiting | Leeds | LS9 7TF | United Kingdom |
| St Bartholomew's Hospital - Barts Health NHS Trust | Recruiting | London | EC1A 7BE | United Kingdom |
| University College London Hospitals NHS Foundation Trust | Recruiting | London | NW2 1PG | United Kingdom |
| The Royal Free Hospital - Royal Free London NHS Foundation Trust | Recruiting | London | NW3 2QG | United Kingdom |
| Sarah Cannon Research Institute | Recruiting | London | W1G 6AD | United Kingdom |
| Churchill Hospital - Oxford University Hospitals NHS Foundation Trust | Recruiting | Oxford | OX3 7LE | United Kingdom |
| North Wales Cancer Treatment C - Glan Clwyd Hospital | Recruiting | Rhyl | LL18 5UJ | United Kingdom |
| Southampton General Hospital - University Hospital Southampton NHS Foundation Trust | Recruiting | Southampton | SO16 6YD | United Kingdom |
| Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust | Recruiting | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Torbay Hosptial, South Devon Healthcare NHS Foundation Trust | Recruiting | Torquay | TQ2 7AA | United Kingdom |
| New Cross Hospital - The Royal Wolverhampton NHS Trust | Recruiting | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| D016190 | Carboplatin |
| C490954 | eribulin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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