Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523602-33 | Other Identifier | EU CT Number | |
| U1111-1327-4912 | Other Identifier | UTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BioNTech SE | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1A | Experimental |
| |
| Cohort 1B | Experimental |
| |
| Cohort 2A | Experimental |
| |
| Cohort 2B | Experimental |
| |
| Cohort 2C | Experimental |
| |
| Cohort 1A2 | Experimental |
| |
| Cohort 1B2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pumitamig | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Phase 1 | Up to approximately 25 weeks |
| Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5)) | Phase 1 | Up to approximately 25 weeks |
| Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria | Phase 1 | Up to day 21 |
| Number of participants with AEs leading to discontinuation | Phase 1 | Up to approximately 25 weeks |
| Number of participants with AEs leading to death | Phase 1 | Up to approximately 25 weeks |
| Objective response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment | Phase 2 | Up to week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with AEs | Phase 2 | Up to approximately 25 weeks |
| Number of participants with SAEs (as per CTCAE v5) | Phase 2 | Up to approximately 25 weeks |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0137 | Not yet recruiting | Duarte | California | 91010 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ipilimumab | Drug | Specified dose on specified days |
|
|
| Number of participants with treatment-related adverse events (TRAEs) | Phase 2 | Up to approximately 25 weeks |
| Number of participants with AEs leading to discontinuation | Phase 2 | Up to approximately 25 weeks |
| Number of participants with AEs leading to death | Phase 2 | Up to approximately 25 weeks |
| End of infusion concentration of Pumitamig | Phase 2 | Up to day 21 |
| End of trough concentration of Pumitamig | Phase 2 | Up to day 21 |
| Trough concentration of Ipilimumab | Phase 2 | Up to day 21 |
| Incidence of anti-drug antibodies against Pumitamig | Phase 2 | Up to 5 years |
| Incidence of anti-drug antibodies against Ipilimumab | Phase 2 | Up to 5 years |
| Progression-free survival (PFS) by RECIST v1.1 per investigator assessment | Phase 2 | Up to 4 years |
| Duration of response (DOR) (confirmed by PR or CR) by RECIST v1.1 per investigator assessment | Phase 2 | Up to 4 years |
| Local Institution - 0070 | Not yet recruiting | Los Angeles | California | 90064 | United States |
|
| Local Institution - 0107 | Not yet recruiting | Chicago | Illinois | 60611 | United States |
|
| Local Institution - 0134 | Not yet recruiting | Detroit | Michigan | 48202 | United States |
|
| John Theurer Cancer Center at Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601-2191 | United States |
|
| Local Institution - 0100 | Not yet recruiting | Mineola | New York | 11501 | United States |
|
| Providence Portland Medical Center | Recruiting | Portland | Oregon | 97213 | United States |
|
| Providence St. Vincent Medical Center | Recruiting | Portland | Oregon | 97225 | United States |
|
| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
|
| Local Institution - 0083 | Not yet recruiting | Seattle | Washington | 98109-1024 | United States |
|
| Royal Prince Alfred Hospital | Recruiting | Camperdown | New South Wales | 2050 | Australia |
|
| Local Institution - 0033 | Not yet recruiting | Westmead | New South Wales | 2145 | Australia |
|
| Sunshine Coast University Hospital | Recruiting | Birtinya | Queensland | 4575 | Australia |
|
| The Royal Melbourne Hospital | Recruiting | Parkville | Victoria | 3052 | Australia |
|
| Bradfordhill | Recruiting | Santiago | Santiago Metropolitan | 8420383 | Chile |
|
| Pontifica Universidad Catolica De Chile | Recruiting | Santiago Region Metropolitana | Santiago Metropolitan | 8330034 | Chile |
|
| Local Institution - 0114 | Not yet recruiting | Beijing | Beijing Municipality | 100036 | China |
|
| Local Institution - 0125 | Not yet recruiting | Chongqing | Chongqing Municipality | 400016 | China |
|
| Local Institution - 0116 | Not yet recruiting | Fuzhou | Fujian | 350025 | China |
|
| Local Institution - 0075 | Not yet recruiting | Guangzhou | Guangdong | 510515 | China |
|
| Local Institution - 0130 | Not yet recruiting | Harbin | Heilongjiang | 150001 | China |
|
| Local Institution - 0128 | Not yet recruiting | Nanyang | Henan | 473000 | China |
|
| Local Institution - 0119 | Not yet recruiting | Nanjing | Jiangsu | 210008 | China |
|
| Local Institution - 0123 | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
|
| Local Institution - 0115 | Not yet recruiting | Xi'an | Shaanxi | 710038 | China |
|
| Local Institution - 0086 | Not yet recruiting | Xi'an | Shaanxi | 710126 | China |
|
| Local Institution - 0118 | Not yet recruiting | Jinan | Shandong | 250117 | China |
|
| Local Institution - 0078 | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Local Institution - 0126 | Not yet recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| CHU Bordeaux Haut-Leveque | Recruiting | Pessac | Aquitaine | 33600 | France |
|
| Centre Hospitalier Universitaire de Grenoble | Recruiting | La Tronche | Auvergne-Rhône-Alpes | 38700 | France |
|
| Local Institution - 0001 | Not yet recruiting | Montpellier | Languedoc-Roussillon | 34295 | France |
|
| Local Institution - 0018 | Not yet recruiting | Saint Priest En Jarez | Pays de la Loire Region | 42270 | France |
|
| Local Institution - 0003 | Not yet recruiting | Bobigny | 93000 | France |
|
| Local Institution - 0031 | Not yet recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
|
| Universitatsklinikum Schleswig-Holstein | Recruiting | Lübeck | Schleswig-Holstein | 23538 | Germany |
|
| Universitaetsklinikum Frankfurt | Recruiting | Frankfurt | D-60590 | Germany |
|
| Local Institution - 0026 | Not yet recruiting | Mainz | 55101 | Germany |
|
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" | Recruiting | Meldola | Emilia-Romagna | 47014 | Italy |
|
| Local Institution - 0109 | Not yet recruiting | Pisa | Tuscany | 56126 | Italy |
|
| Local Institution - 0089 | Not yet recruiting | Milan | 20132 | Italy |
|
| Local Institution - 0016 | Not yet recruiting | Pisa | 56126 | Italy |
|
| Local Institution - 0017 | Not yet recruiting | Osakasayama-shi | Osaka | 5898511 | Japan |
|
| Local Institution - 0008 | Not yet recruiting | Kashiwa | 277-8577 | Japan |
|
| Local Institution - 0021 | Not yet recruiting | Wroclaw | Lower Silesian Voivodeship | 53-439 | Poland |
|
| Local Institution - 0105 | Not yet recruiting | Warsaw | Masovian Voivodeship | 02-106 | Poland |
|
| Local Institution - 0020 | Not yet recruiting | Gdansk | 80-952 | Poland |
|
| Local Institution - 0009 | Not yet recruiting | Singapore | 119074 | Singapore |
|
| Local Institution - 0012 | Not yet recruiting | Singapore | 169610 | Singapore |
|
| Local Institution - 0027 | Not yet recruiting | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
|
| Local Institution - 0013 | Not yet recruiting | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
|
| Local Institution - 0011 | Not yet recruiting | Seoul | Seoul-teukbyeolsi | 05505 | South Korea |
|
| Local Institution - 0014 | Not yet recruiting | Pamplona | Navarre | 31008 | Spain |
|
| Local Institution - 0015 | Not yet recruiting | Barcelona | 8036 | Spain |
|
| Hospital General Universitario Gregorio Marañon | Recruiting | Madrid | 28007 | Spain |
|
| Local Institution - 0095 | Not yet recruiting | Madrid | 28050 | Spain |
|
| Local Institution - 0032 | Not yet recruiting | Taichung | 404332 | Taiwan |
|
| National Cheng Kung University Hospital | Recruiting | Tainan | 704 | Taiwan |
|
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
|
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
|
| Hammersmith Hospital | Recruiting | London | London, City of | W12 0HS | United Kingdom |
|
| Cancer Research UK - The Beatson Institute for Cancer Research (Cancer Research UK Beatson Laboratories) | Recruiting | Glasgow | South Western Scotland | G611BD | United Kingdom |
|
| Local Institution - 0053 | Not yet recruiting | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided