Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004833-18 | EudraCT Number |
Not provided
Not provided
Not provided
The study was prematurely discontinued by the sponsor due to probability of success which was too low to justify the continuation of recruitment.
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| Name | Class |
|---|---|
| Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The main purpose of this study was to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test.
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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, unacceptable toxicity, study withdrawal or death. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC) | The ORR was defined as the percentage of participants with a confirmed objective response of Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 as assessed by IRC. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. | Time from first study intervention up to 321 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) According to RECIST Version 1.1 | DOR was defined for participants with a confirmed objective response as the time from first documentation of a confirmed objective response (CR or PR) according to RECIST 1.1 to the date of first documentation of objective PD or death due to any cause, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (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. |
Not provided
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 |
|---|---|---|---|---|---|---|
| Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center, Suite 3400 | Newark | Delaware | 19713-2055 | United States | ||
Not provided
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
Not provided
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.
A total of 15 participants were screened, of which 11 participants received bintrafusp alfa monotherapy.
Not provided
Not provided
| 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 |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 6, 2021 | Jan 25, 2023 |
Not provided
Not provided
Not provided
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|
| From first documented objective response to PD or death due to any cause, assessed up to 321 days |
| Durable Response Rate (DRR) of at Least 6 Months Assessed by an Independent Review Committee (IRC) | DRR was defined as the number of participants having a DOR of at least 6 months, out of the total number of participants. | Time from first study intervention up to 321 days |
| Progression-Free Survival (PFS) According to RECIST Version 1.1 Assessed by the IRC | PFS was defined as the time from first study intervention until the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PD: At least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The tumor response was determined according to RECIST version 1.1 and assessed by the IRC. | Time from first study intervention up to until the first documentation of PD or death, assessed up to 321 days |
| Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator | DOR was defined for participants with a confirmed objective response as the time from first documentation of a confirmed objective response (CR or PR) according to RECIST 1.1 to the date of first documentation of objective PD or death due to any cause, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. PD: At least a 20% 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 investigator. | From first documented objective response to PD or death due to any cause, assessed up to 321 days |
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator | The ORR was defined as the percentage of participants with a confirmed objective response of Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 as assessed by investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. | Time from first study intervention up to 321 days |
| Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator | DRR was defined as the number of participants having a DOR of at least 6 months, out of the total number of participants. | Time from first study intervention up to 321 days |
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator | PFS was defined as the time from first study intervention until the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PD: At least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The tumor response was determined according to RECIST version 1.1 and assessed by the investigator. | Time from first study intervention up to the first documentation of PD or death, assessed up to 321 days |
| Overall Survival (OS) | OS was defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of analysis are censored at the date of the last follow-up. OS was summarized by Kaplan-Meier (KM) methods. | Time from the first dose of study drug until occurrence of death due to any cause, assessed up to 321 days |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, and Adverse Events of Special Interest (AESIs) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. 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. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. The AESIs considered in this study are infusion-related reactions including immediate hypersensitivity, immune-related adverse events, skin adverse events, bleeding events and anemia. | Time from first study intervention up to 321 days |
| Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa | Ceoi was the serum concentration observed immediately at the end of infusion. This was taken directly from the observed bintrafusp alfa concentration-time data. | Pre-dose, End of Infusion from Day 1 to 321 |
| Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa | Ctrough was the serum concentration observed immediately before next dosing. | Pre-dose, End of Infusion from Day 1 to 321 |
| Number of Participants With Positive Anti-Drug Antibody (ADA) of Bintrafusp Alfa | The detection of antibodies to bintrafusp alfa was performed using a validated ADA assay method with tiered testing of screening, confirmatory and titration. | Pre-dose, End of Infusion from Day 1 to 321 |
| Mayo Clinic-Jacksonville |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Maryland Oncology Hematology, P.A. | Silver Spring | Maryland | 20904 | United States |
| New York Oncology Hematology, P.C. - Albany | Albany | New York | 12206 | United States |
| TheOhio State University, Stefanie Spielman Comprehensive Breast Center | Columbus | Ohio | 43212 | United States |
| UPMC Hillman Cancer Center - Hillman Cancer Center | Monroeville | Pennsylvania | 15146 | United States |
| Charleston Hematology Oncology Associates, PA | Charleston | South Carolina | 29414 | United States |
| The West Clinic | Germantown | Tennessee | 38138 | United States |
| Texas Oncology, P.A. - Austin - Austin Central Cancer Center | Austin | Texas | 78731 | United States |
| Texas Oncology, P.A. - Medical City Dallas - Pediatric Hematology/Oncology | Dallas | Texas | 75230 | United States |
| Texas Oncology, P.A. - Plano | Plano | Texas | 75075 | United States |
| Texas Oncology-San Antonio Stone Oak | San Antonio | Texas | 78240 | United States |
| Texas Oncology, P.A. - Tyler | Tyler | Texas | 75702 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Virginia Oncology Associates - Hampton | Norfolk | Virginia | 23502 | United States |
| Universitair Ziekenhuis Brussel - Geriatrie | Brussels | Belgium |
| UZ Leuven | Leuven | Belgium |
| AZ Sint-Maarten - PARENT | Mechelen | Belgium |
| Centre François Baclesse - Pathologies Gynecologiques | Caen | France |
| Centre Léon Bérard | Lyon | France |
| Hôpital Privé du Confluent SAS | Nantes | France |
| Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale | Paris | France |
| CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie | Plérin | France |
| Institut Curie - Centre René Huguenin - Service d'Oncologie Médicale | Saint-Cloud | France |
| IEO Istituto Europeo di Oncologia | Milan | Italy |
| Ospedale San Raffaele | Milan | Italy |
| Istituto Nazionale Tumori Fondazione G. Pascale - Dipartimento di Senologia | Naples | Italy |
| IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2 | Padova | Italy |
| Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II | Pisa | Italy |
| Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica | Roma | Italy |
| Istituto Clinico Humanitas | Rozzano | Italy |
| SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" - Chemotherapy | Arkhangelsk | Russia |
| SBIH " Clinical Oncological Dispensary # 1" - Location | Krasnodar | Russia |
| SBIH " Clinical Oncological Dispensary 1" - Location | Krasnodar | Russia |
| FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" - Moscow Cancer Research Centre | Moscow | Russia |
| BHI of Omsk region "Clinical Oncology Dispensary" | Omsk | Russia |
| LLC "ClinicaUZI4D" | Pyatigorsk | Russia |
| FSBI "Clinical Research and Practical Center for specialized medical care (oncology)" | Saint Petersburg | Russia |
| Tomsk Research Instutite of Oncology - Chemotherapy | Tomsk | Russia |
| SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan | Ufa | Russia |
| Hospital Universitario Reina Sofia - Dept of Oncology | Córdoba | Spain |
| Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica | Madrid | Spain |
| Hospital Ruber Internacional - Servicio de Oncologia | Madrid | Spain |
| Hospital Universitario Ramon y Cajal - Servicio de Oncologia | Madrid | Spain |
| Hospital Universitario Virgen del Rocio - Servicio de Oncologia | Seville | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full analysis set (FAS) included all participants, who were administered at least one infusion of bintrafusp alfa.
Not provided
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC) | The ORR was defined as the percentage of participants with a confirmed objective response of Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 as assessed by IRC. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. | As per changes in planned analysis, the outcome measure related to efficacy were not assessed. | Posted | Time from first study intervention up to 321 days |
|
| |||||||||||||||||||
| Secondary | Duration of Response (DOR) According to RECIST Version 1.1 | DOR was defined for participants with a confirmed objective response as the time from first documentation of a confirmed objective response (CR or PR) according to RECIST 1.1 to the date of first documentation of objective PD or death due to any cause, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (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. | As per changes in planned analysis, the outcome measure related to efficacy were not assessed. | Posted | From first documented objective response to PD or death due to any cause, assessed up to 321 days |
|
| |||||||||||||||||||
| Secondary | Durable Response Rate (DRR) of at Least 6 Months Assessed by an Independent Review Committee (IRC) | DRR was defined as the number of participants having a DOR of at least 6 months, out of the total number of participants. | As per changes in planned analysis, the outcome measure related to efficacy were not assessed. | Posted | Time from first study intervention up to 321 days |
|
| |||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) According to RECIST Version 1.1 Assessed by the IRC | PFS was defined as the time from first study intervention until the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PD: At least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The tumor response was determined according to RECIST version 1.1 and assessed by the IRC. | As per changes in planned analysis, the outcome measure related to efficacy were not assessed. | Posted | Time from first study intervention up to until the first documentation of PD or death, assessed up to 321 days |
|
| |||||||||||||||||||
| Secondary | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator | DOR was defined for participants with a confirmed objective response as the time from first documentation of a confirmed objective response (CR or PR) according to RECIST 1.1 to the date of first documentation of objective PD or death due to any cause, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. PD: At least a 20% 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 investigator. | As per changes in planned analysis, the outcome measure related to efficacy were not assessed. | Posted | From first documented objective response to PD or death due to any cause, assessed up to 321 days |
|
| |||||||||||||||||||
| Secondary | Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator | The ORR was defined as the percentage of participants with a confirmed objective response of Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 as assessed by investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. | As per changes in planned analysis, the outcome measure related to efficacy were not assessed. | Posted | Time from first study intervention up to 321 days |
|
| |||||||||||||||||||
| Secondary | Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator | DRR was defined as the number of participants having a DOR of at least 6 months, out of the total number of participants. | As per changes in planned analysis, the outcome measure related to efficacy were not assessed. | Posted | Time from first study intervention up to 321 days |
|
| |||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator | PFS was defined as the time from first study intervention until the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PD: At least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The tumor response was determined according to RECIST version 1.1 and assessed by the investigator. | As per changes in planned analysis, the outcome measure related to efficacy were not assessed. | Posted | Time from first study intervention up to the first documentation of PD or death, assessed up to 321 days |
|
| |||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of analysis are censored at the date of the last follow-up. OS was summarized by Kaplan-Meier (KM) methods. | As per changes in planned analysis, the outcome measure related to efficacy were not assessed. | Posted | Time from the first dose of study drug until occurrence of death due to any cause, assessed up to 321 days |
|
| |||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, and Adverse Events of Special Interest (AESIs) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. 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. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. The AESIs considered in this study are infusion-related reactions including immediate hypersensitivity, immune-related adverse events, skin adverse events, bleeding events and anemia. | The Safety Analysis Set (SAF) analysis set included all participants who received at least 1 dose of study intervention. | Posted | Number | Count of Participants | Time from first study intervention up to 321 days |
| ||||||||||||||||||
| Secondary | Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa | Ceoi was the serum concentration observed immediately at the end of infusion. This was taken directly from the observed bintrafusp alfa concentration-time data. | As per changes in planned analysis, the outcome measure related to pharmacokinetics were not assessed. | Posted | Pre-dose, End of Infusion from Day 1 to 321 |
|
| |||||||||||||||||||
| Secondary | Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa | Ctrough was the serum concentration observed immediately before next dosing. | As per changes in planned analysis, the outcome measure related to pharmacokinetics were not assessed. | Posted | Pre-dose, End of Infusion from Day 1 to 321 |
|
| |||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-Drug Antibody (ADA) of Bintrafusp Alfa | The detection of antibodies to bintrafusp alfa was performed using a validated ADA assay method with tiered testing of screening, confirmatory and titration. | As per changes in planned analysis, the outcome measure related to pharmacokinetics were not assessed. | Posted | Pre-dose, End of Infusion from Day 1 to 321 |
|
|
Time from first study intervention up to 321 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. | 6 | 11 | 7 | 11 | 9 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA version 24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increase | Investigations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Blood thyroid stimulating hormone dec | Investigations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Thyroxine free increased | Investigations | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 24.1 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA version 24.1 | Non-systematic Assessment |
|
Based on sponsors decision for early termination of the study due to lack of probability to achieve interim data allowing expansion of this study.
Hence, analysis for efficacy, or biomarker were not performed.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center, | Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | +49 6151725200 | service@emdgroup.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 21, 2021 | Jan 25, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|