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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003583-40 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bintrafusp alfa | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bintrafusp alfa | Drug | Participants received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, death, unacceptable toxicity and study withdrawal. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). 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. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC. | Time from first treatment up to 688 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | DOR was defined for participants with confirmed response, as the time from first documentation of confirmed objective response (Complete Response [CR] or Partial Response [PR]) according to RECIST 1.1 to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates. |
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Inclusion Criteria:
Participants who had advanced unresectable and/or metastatic cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma) with disease progression during or after the prior platinum-containing chemotherapy:
Participants who had measurable disease
Participants who provide a tumor tissue sample, either from archival tissue or newly obtained core or excisional biopsy. If the participant received local therapy (For example: radiation therapy or chemoradiotherapy) after the archival tissue was taken, a new biopsy was required
Participants who had Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
Life expectancy greater than or equals to (>=) 12 weeks as judged by the Investigator
Adequate hematological, hepatic and renal function as defined in the protocol
Participants with known Human Immunodeficiency Virus (HIV) infections were in general eligible if the following criteria are met:
Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections were in general eligible if the following criteria are met:
Other protocol defined inclusion criteria could apply
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 |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| University of Arkansas Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29298798 | Background | Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marte JL, Donahue RN, Grenga I, Cordes L, Christensen O, Mahnke L, Helwig C, Gulley JL. Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFbeta, in Advanced Solid Tumors. Clin Cancer Res. 2018 Mar 15;24(6):1287-1295. doi: 10.1158/1078-0432.CCR-17-2653. Epub 2018 Jan 3. | |
| 29343622 |
| 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 203 participants were screened, of which 146 participants received bintrafusp alfa monotherapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bintrafusp Alfa | Participants received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death. |
| 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 | Jun 22, 2021 | Apr 3, 2023 |
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|
| Time from first treatment up to 688 days |
| Durable Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Durable Response was defined as the number of participants with confirmed objective response (CR or PR) according to RECIST 1.1, determined by IRC with 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 SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | Time from first treatment up to 688 days |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention. AESIs included Infusion-related reactions, Immune-related AEs, Transforming growth factor- beta (TGF-ß) inhibition mediated skin AE, bleeding and anemia. | Time from first treatment up to 688 days |
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) | PFS was defined as the time from first administration of study intervention until date of the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Kaplan-Meier estimates was used to calculate PFS. | Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days |
| Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator | Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). 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. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by Investigator. | Time from first treatment up to 688 days |
| Overall Survival (OS) | OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method. | Time from first administration of study drug up to data cutoff (assessed up to 688 days) |
| Serum Pre-Dose Concentrations (Ctrough) of Bintrafusp Alfa | Ctrough was defined as the concentration observed immediately before next dosing (corresponding to pre-dose or trough concentration for multiple dosing). | At Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505 and Day 589 |
| Serum Concentration at End of Infusion (CEOI) of Bintrafusp Alfa | Serum Concentration at End of Infusion (CEOI) of bintrafusp alfa is reported. | At Day 1 and Day 29 |
| Number of Participants With Positive Antidrug Antibodies (ADA) | Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported. | Time from first treatment up to 688 days |
| Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression | Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). 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. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC through PD-L1 Subgroup. Participants with PD-L1 positive tumors (Combined positive score (CPS) >=1) and PD-L1 negative tumors (CPS<1). | Time from first treatment up to 688 days |
| PFS According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression | PFS was defined as the time from first administration of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was determined according to RECIST v1.1 and as adjudicated by IRC through PD-L1 Subgroup. Participants with PD-L1 positive tumors (Combined positive score (CPS) >=1) and PD-L1 negative tumors (CPS<1). | Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days |
| Overall Survival (OS) as Assessed According to Programmed Death Ligand 1 (PD-L1) Expression | OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method. Participants with PD-L1 positive tumors (Combined positive score (CPS) >=1) and PD-L1 negative tumors (CPS<1). | Time from first administration of study drug up to 688 days |
| Little Rock |
| Arkansas |
| 72202-3500 |
| United States |
| Stanford University Hospital and Clinics - Stanford Cancer Center | Stanford | California | 94305 | United States |
| The Stamford Hospital | Stamford | Connecticut | 06902 | United States |
| Karmanos Cancer Institute | Farmington Hills | Michigan | 48334 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89074 | United States |
| UC Health Clinical Trials Office | Cincinnati | Ohio | 45229 | United States |
| Oregon Health & Science University | Portland | Oregon | 97229 | United States |
| The West Clinic | Germantown | Tennessee | 38138 | United States |
| SCRI - Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Centro Oncologico Riojano Integral (CORI) | La Rioja | Argentina |
| Sanatorio El Parque | Salta | Argentina |
| Centro Medico San Roque S.R.L. | San Miguel de Tucumán | Argentina |
| Peter MacCallum Cancer Centre-East Melbourne | Melbourne | Australia |
| Linear Clinical Research Limited | Nedlands | Australia |
| Calvary Mater Newcastle | Waratah | Australia |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium |
| Institut Jules Bordet | Brussels | Belgium |
| Universitair Ziekenhuis Gent - Pneumology | Ghent | Belgium |
| AZ Groeninge - Campus Kennedylaan - account 2 | Kortrijk | Belgium |
| CHU de Liège - PARENT | Liège | Belgium |
| CHU Sart Tilman | Liège | Belgium |
| UZ Leuven | Pellenberg | Belgium |
| GZA Ziekenhuizen - Campus Sint-Augustinus | Wilrijk | Belgium |
| HGB - Hospital Giovanni Battista - Mãe de Deus Center - Centro de Pesquisa Clínica - Instituto do Câncer | Porto Alegre | Brazil |
| Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda. | São Paulo | Brazil |
| IBCC - Instituto Brasileiro de Controle do Câncer | São Paulo | Brazil |
| Chongqing Cancer Hospital | Chongqing | China |
| Sun Yat-sen University, Cancer Center | Guangzhou | China |
| Zhejiang Cancer Hospital | Hangzhou | China |
| Anhui Provincial Hospital | Hefei | China |
| Shanghai Cancer Hospital, Fudan University | Shanghai | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | China |
| Henan Cancer Hospital | Zhengzhou | China |
| Institut Bergonié | Bordeaux | France |
| Centre Oscar lambret - Service d'Oncologie medicale | Lille | France |
| Centre Léon Bérard | Lyon | France |
| Centre Antoine Lacassagne | Nice | France |
| Hôpital Cochin - Hematologie et Oncologie Médicale | Paris | France |
| Centre Hospitalier Lyon Sud - service d'oncologie medicale | Pierre-Bénite | France |
| CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie | Plérin | France |
| Institut Jean Godinot - Service d'hématologie et Oncologie Médicale | Reims | France |
| ICO - Site René Gauducheau | Saint-Herblain | France |
| Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale | Strasbourg | France |
| Orszagos Onkologiai Intezet - Nogyogyaszati Osztaly | Budapest | Hungary |
| SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz - Onkoradiologia | Nyíregyháza | Hungary |
| National Cancer Center Hospital - Dept of Mammary Gland/Oncology | Chūōku | Japan |
| NHO Kyushu Cancer Center - Dept of Gynecology | Fukuoka | Japan |
| Saitama Medical University International Medical Center - Dept of Gynecology/Oncology | Hidaka-shi | Japan |
| Cancer Institute Hospital of JFCR - Dept of Gynecology | Kōtoku | Japan |
| Kurume University Hospital - Dept of Gynecology | Kurume-shi | Japan |
| Jikei University Hospital - Dept of Gynecology | Minatoku | Japan |
| University Hospital, University of the Ryukyus - Dept of Obstetrics/Gynecology | Nakagami-gun | Japan |
| Osaka International Cancer Institute - Dept of Gynecology | Osaka | Japan |
| NHO Hokkaido Cancer Center - Dept of Gynecology | Sapporo | Japan |
| Kanagawa Cancer Center - Dept of Gynecology | Yokohama | Japan |
| BHI of Omsk region "Clinical Oncology Dispensary" | Omsk | Russia |
| LLC "ClinicaUZI4D" | Pyatigorsk | Russia |
| National Cancer Center | Goyang-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 |
| Ajou University Hospital | Suwon | South Korea |
| Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia | Barcelona | Spain |
| Hospital Universitari Vall d'Hebron - Dept of Oncology | Barcelona | Spain |
| ICO Girona - Hospital Doctor Josep Trueta - Servicio de Oncologia Medica | Girona | Spain |
| Clinica Universidad de Navarra (MAD) - Oncology Service | Madrid | Spain |
| Hospital Universitario 12 de Octubre - Servicio de Oncologia | Madrid | Spain |
| Hospital Universitario Ramon y Cajal - Servicio de Oncologia | Madrid | Spain |
| Hospital Regional Universitario de Malaga | Málaga | Spain |
| Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica | Valencia | Spain |
| Background |
| Lan Y, Zhang D, Xu C, Hance KW, Marelli B, Qi J, Yu H, Qin G, Sircar A, Hernandez VM, Jenkins MH, Fontana RE, Deshpande A, Locke G, Sabzevari H, Radvanyi L, Lo KM. Enhanced preclinical antitumor activity of M7824, a bifunctional fusion protein simultaneously targeting PD-L1 and TGF-beta. Sci Transl Med. 2018 Jan 17;10(424):eaan5488. doi: 10.1126/scitranslmed.aan5488. |
| 36066618 | Background | Vugmeyster Y, Grisic AM, Wilkins JJ, Loos AH, Hallwachs R, Osada M, Venkatakrishnan K, Khandelwal A. Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1. Cancer Chemother Pharmacol. 2022 Oct;90(4):369-379. doi: 10.1007/s00280-022-04468-6. Epub 2022 Sep 6. |
| 39052242 | Derived | Birrer M, Li G, Yunokawa M, Lee JY, Kim BG, Oppermann CP, Zhou Q, Nishio S, Okamoto A, Wu X, Mileshkin L, Oaknin A, Ray-Coquard I, Hasegawa K, Jehl G, Vugmeyster Y, Zhang S, Bajars M, Yonemori K. Bintrafusp Alfa for Recurrent or Metastatic Cervical Cancer After Platinum Failure: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Sep 1;10(9):1204-1211. doi: 10.1001/jamaoncol.2024.2145. |
| US Medical Information website, Medical Resources | View source |
| COMPLETED |
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| NOT COMPLETED |
|
The Full analysis set (FAS) included all participants, who were administered at least one dose of bintrafusp alfa.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bintrafusp Alfa | Participants received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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 | Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). 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. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC. | FAS included all participants who were administered at least one dose of bintrafusp alfa. | Posted | Count of Participants | Participants | Time from first treatment up to 688 days |
|
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| Secondary | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | DOR was defined for participants with confirmed response, as the time from first documentation of confirmed objective response (Complete Response [CR] or Partial Response [PR]) according to RECIST 1.1 to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates. | FAS included all participants who were administered at least one dose of bintrafusp alfa. | Posted | Median | 95% Confidence Interval | months | Time from first treatment up to 688 days |
|
| ||||||||||||||||||||||||||
| Secondary | Durable Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Durable Response was defined as the number of participants with confirmed objective response (CR or PR) according to RECIST 1.1, determined by IRC with 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 SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. | FAS included all participants who were administered at least one dose of bintrafusp alfa. | Posted | Count of Participants | Participants | Time from first treatment up to 688 days |
|
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention. AESIs included Infusion-related reactions, Immune-related AEs, Transforming growth factor- beta (TGF-ß) inhibition mediated skin AE, bleeding and anemia. | Safety analysis set included all participants who were administered at least one dose of bintrafusp alfa | Posted | Count of Participants | Participants | Time from first treatment up to 688 days |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) | PFS was defined as the time from first administration of study intervention until date of the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Kaplan-Meier estimates was used to calculate PFS. | FAS included all participants who were administered at least one dose of bintrafusp alfa. | Posted | Median | 95% Confidence Interval | months | Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator | Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). 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. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by Investigator. | FAS included all participants who were administered at least one dose of bintrafusp alfa. | Posted | Count of Participants | Participants | Time from first treatment up to 688 days |
|
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| Secondary | Overall Survival (OS) | OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method. | FAS included all participants who were administered at least one dose of bintrafusp alfa. | Posted | Median | 95% Confidence Interval | months | Time from first administration of study drug up to data cutoff (assessed up to 688 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Pre-Dose Concentrations (Ctrough) of Bintrafusp Alfa | Ctrough was defined as the concentration observed immediately before next dosing (corresponding to pre-dose or trough concentration for multiple dosing). | Pharmacokinetic (PK) analysis set included all participants who completed at least one dose of bintrafusp alfa and who provided at least one sample with a measurable concentration of bintrafusp alfa. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (mcg/mL) | At Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505 and Day 589 |
|
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| Secondary | Serum Concentration at End of Infusion (CEOI) of Bintrafusp Alfa | Serum Concentration at End of Infusion (CEOI) of bintrafusp alfa is reported. | PK analysis set included all participants who completed at least one dose of Bintrafusp Alfa and who provided at least one sample with a measurable concentration of Bintrafusp Alfa. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | At Day 1 and Day 29 |
|
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| Secondary | Number of Participants With Positive Antidrug Antibodies (ADA) | Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported. | Immunogenicity analysis set included all participants who received at least one dose of bintrafusp alfa and who had at least one valid result of ADA. | Posted | Count of Participants | Participants | Time from first treatment up to 688 days |
|
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| Secondary | Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression | Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). 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. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC through PD-L1 Subgroup. Participants with PD-L1 positive tumors (Combined positive score (CPS) >=1) and PD-L1 negative tumors (CPS<1). | FAS included all participants who were administered at least one dose of bintrafusp alfa. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified categories for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Time from first treatment up to 688 days |
| |||||||||||||||||||||||||||
| Secondary | PFS According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression | PFS was defined as the time from first administration of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was determined according to RECIST v1.1 and as adjudicated by IRC through PD-L1 Subgroup. Participants with PD-L1 positive tumors (Combined positive score (CPS) >=1) and PD-L1 negative tumors (CPS<1). | FAS included all participants who were administered at least one dose of bintrafusp alfa. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified categories for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) as Assessed According to Programmed Death Ligand 1 (PD-L1) Expression | OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method. Participants with PD-L1 positive tumors (Combined positive score (CPS) >=1) and PD-L1 negative tumors (CPS<1). | FAS included all participants who were administered at least one dose of bintrafusp alfa. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified categories for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Time from first administration of study drug up to 688 days |
|
|
Time from first treatment up to 688 days
Not provided
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 | Bintrafusp Alfa | Participants received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death. | 76 | 146 | 94 | 146 | 139 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Immune-mediated thyroiditis | Endocrine disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Malignant gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Obstructive defaecation | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Intestinal fistula infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Septic arthritis streptococcal | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cystitis radiation | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Radiation proctitis | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Stoma obstruction | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Non-systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Neuritis | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Polyneuropathy in malignant disease | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 24.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Ureteral polyp | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Immune-mediated dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | 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_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2022 | Apr 3, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723824 | bintrafusp alfa protein, human |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Participants |
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| Units |
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| Counts |
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| Participants |
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