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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000179-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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This study is designed to provide continuous access to treatment with bintrafusp alfa for eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) and to collect long-term safety and efficacy data.
Study Duration: All participants in this rollover study will be treated with bintrafusp alfa until meeting defined criteria in the protocol for discontinuation, until study intervention is commercially accessible and provisioned via marketed product, or until end of study.
The study also includes a 5 years survival follow-up after last dose of the study treatment.
Treatment Duration: Treatment under the rollover protocol according to the interval and dosing schedule in the parent protocol until discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bintrafusp alfa | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bintrafusp alfa | Drug | Participants who are continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight which is (i.e.) milligrams per kilogram (mg/kg) dose in a parent protocol, will receive an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 week or, 2400 mg once every 3 weeks. Participants who are entering the rollover study after discontinuation of treatment in a parent study will receive bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related AEs (TRAEs) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. TEAEs were defined as AEs emerging or worsening after start of treatment until 30 days after end of treatment. TRAE was defined as any AE considered as related to study treatment. | Baseline in parent study (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) upto end of current rollover study (approximately assessed upto a maximum of 9 years, 6 months, 22 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from study day 1 in parent study to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method. | Baseline in parent study (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) upto end of current rollover study (approximately assessed upto a maximum of 9 years, 6 months, 22 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Cancer and Blood Disorders a Division of American Oncology Partners of Maryland, P.A. | Bethesda | Maryland | 20817 | United States |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Biliary Tract Cancer | Participants with biliary tract cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight (i.e., milligrams per kilogram (mg/kg) dose) in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
| FG001 | Non-small Cell Lung Cancer | Participants with Non small cell lung cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
| FG002 | Cervical Cancer | Participants with cervical cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
| FG003 | Other (Colorectal Cancer, Glioblastoma, Melanoma) | Participants with Other (Colorectal cancer, Glioblastoma, Melanoma) who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biliary Tract Cancer | Participants with biliary tract cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight (i.e., milligrams per kilogram (mg/kg) dose) in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Treatment Emergent Adverse Events (TEAEs) and Treatment Related AEs (TRAEs) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. TEAEs were defined as AEs emerging or worsening after start of treatment until 30 days after end of treatment. TRAE was defined as any AE considered as related to study treatment. | Safety analysis set included all participants who received at least one dose of study intervention in the Rollover study. | Posted | Count of Participants | Participants | Baseline in parent study (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) upto end of current rollover study (approximately assessed upto a maximum of 9 years, 6 months, 22 days) |
|
From the first dose of study intervention in the Rollover study to the last administration of study intervention + 30 days (approximately 39 months and 21 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biliary Tract Cancer | Participants with biliary tract cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight (i.e., milligrams per kilogram (mg/kg) dose) in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
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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 | Nov 30, 2021 | Dec 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2024 | Dec 5, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000723824 | bintrafusp alfa protein, human |
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|
|
| NIH National Institutes of Health/GMB LTIB | Bethesda | Maryland | 20892 | United States |
| Centre Hospitalier de l'Ardenne - PARENT | Libramont | Belgium |
| Harbin Medical University Cancer Hospital | Harbin | China |
| Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I | Dresden | Germany |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica | Lazio | Italy |
| National Cancer Center Hospital | Chūōku | Japan |
| Saitama Medical University International Medical Center | Hidaka-shi | Japan |
| National Cancer Center Hospital East | Kashiwa-shi | Japan |
| BHI of Omsk region "Clinical Oncology Dispensary" - PARENT | Omsk | Russia |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain |
| Hospital Universitario Ramon y Cajal - Servicio de Oncologia | Madrid | Spain |
| Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica | Valencia | Spain |
| Taichung Veterans General Hospital | Taichung | Taiwan |
| Chang Gung Memorial Hospital,Linkou | Taoyuan County | Taiwan |
| Adana City Hospital - Parent Account | Adana | Turkey (Türkiye) |
| Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council - Department of Oncochemotherapy | Lutsk | Ukraine |
| End Of Study Due To Suspension Of Drug Supply |
|
| Stop By Sponsor |
|
| Poor protocol compliance led to sponsor-requested study withdrawal |
|
| BG001 | Non-small Cell Lung Cancer | Participants with Non small cell lung cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
| BG002 | Cervical Cancer | Participants with cervical cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
| BG003 | Other (Colorectal Cancer, Glioblastoma, Melanoma) | Participants with Other (Colorectal cancer, Glioblastoma, Melanoma) who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| OG000 | Biliary Tract Cancer | Participants with biliary tract cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight (i.e., milligrams per kilogram (mg/kg) dose) in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
| OG001 | Non-small Cell Lung Cancer | Participants with Non small cell lung cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
| OG002 | Cervical Cancer | Participants with cervical cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
| OG003 | Other (Colorectal Cancer, Glioblastoma, Melanoma) | Participants with Other (Colorectal cancer, Glioblastoma, Melanoma) who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. |
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from study day 1 in parent study to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method. | Full Analysis Set (FAS) included all participants who received at least one dose of study intervention in the Rollover study. | Posted | Median | 90% Confidence Interval | months | Baseline in parent study (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) upto end of current rollover study (approximately assessed upto a maximum of 9 years, 6 months, 22 days) |
|
|
|
| 1 |
| 10 |
| 3 |
| 10 |
| 8 |
| 10 |
| EG001 | Non-small Cell Lung Cancer | Participants with Non small cell lung cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. | 2 | 5 | 4 | 5 | 3 | 5 |
| EG002 | Cervical Cancer | Participants with cervical cancer, who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Other (Colorectal Cancer, Glioblastoma, Melanoma) | Participants with Other (Colorectal cancer, Glioblastoma, Melanoma) who were continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight i.e., mg/kg dose in a parent protocol (NCT02517398, NCT02699515, NCT04246489, NCT03840915, NCT03631706, NCT04551950, NCT03833661, and NCT04066491), received an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. Participants who entered the rollover study after discontinuation of treatment in a parent study received bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until disease progression, death, unacceptable toxicity, or study withdrawal. | 2 | 4 | 2 | 4 | 3 | 4 |
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Coronavirus infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Ear swelling | Ear and labyrinth disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Axillary pain | General disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Hernia | General disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Localised oedema | General disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Carbuncle | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Upper Respiratory tract infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 27.1 | Non-systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 27.1 | Non-systematic Assessment |
|
Not provided
Not provided
| D012140 |
| Respiratory Tract Diseases |