Trial Outcomes & Findings for Bintrafusp Alfa Program Rollover Study (NCT NCT05061823)

Last Updated: 2026-02-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

22 participants

Primary outcome timeframe

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)

Results posted on

2026-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	10	5	3	4
Overall Study COMPLETED	4	3	2	1
Overall Study NOT COMPLETED	6	2	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
Overall Study Death	1	2	1	2
Overall Study End Of Study Due To Suspension Of Drug Supply	2	0	0	0
Overall Study Stop By Sponsor	2	0	0	1
Overall Study Poor protocol compliance led to sponsor-requested study withdrawal	1	0	0	0

Baseline Characteristics

Bintrafusp Alfa Program Rollover Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biliary Tract Cancer n=10 Participants 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.	Non-small Cell Lung Cancer n=5 Participants 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.	Cervical Cancer n=3 Participants 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.	Other (Colorectal Cancer, Glioblastoma, Melanoma) n=4 Participants 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.	Total n=22 Participants Total of all reporting groups
Age, Continuous	59 Years STANDARD_DEVIATION 10.3 • n=41 Participants	63 Years STANDARD_DEVIATION 7.4 • n=1581 Participants	48 Years STANDARD_DEVIATION 14.4 • n=4626 Participants	52 Years STANDARD_DEVIATION 16.9 • n=72 Participants	57 Years STANDARD_DEVIATION 12.0 • n=11 Participants
Sex: Female, Male Female	3 Participants n=41 Participants	2 Participants n=1581 Participants	3 Participants n=4626 Participants	1 Participants n=72 Participants	9 Participants n=11 Participants
Sex: Female, Male Male	7 Participants n=41 Participants	3 Participants n=1581 Participants	0 Participants n=4626 Participants	3 Participants n=72 Participants	13 Participants n=11 Participants
Race/Ethnicity, Customized Ethnicity-Unknown or Not Reported	10 Participants n=41 Participants	5 Participants n=1581 Participants	3 Participants n=4626 Participants	4 Participants n=72 Participants	22 Participants n=11 Participants
Race/Ethnicity, Customized Race-Asian	10 Participants n=41 Participants	1 Participants n=1581 Participants	2 Participants n=4626 Participants	1 Participants n=72 Participants	14 Participants n=11 Participants
Race/Ethnicity, Customized Race-Black or African American	0 Participants n=41 Participants	1 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants	1 Participants n=11 Participants
Race/Ethnicity, Customized Race-White	0 Participants n=41 Participants	3 Participants n=1581 Participants	1 Participants n=4626 Participants	3 Participants n=72 Participants	7 Participants n=11 Participants

PRIMARY outcome

Timeframe: 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)

Population: Safety analysis set included all participants who received at least one dose of study intervention in the Rollover study.

Outcome measures

Outcome measures
Measure	Biliary Tract Cancer n=10 Participants 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.	Non-small Cell Lung Cancer n=5 Participants 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.	Cervical Cancer n=3 Participants 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.	Other (Colorectal Cancer, Glioblastoma, Melanoma) n=4 Participants 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related AEs (TRAEs) TEAEs	10 Participants	5 Participants	3 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related AEs (TRAEs) TRAEs	10 Participants	5 Participants	3 Participants	4 Participants

SECONDARY outcome

Population: Full Analysis Set (FAS) included all participants who received at least one dose of study intervention in the Rollover study.

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.

Outcome measures

Outcome measures
Measure	Biliary Tract Cancer n=10 Participants 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.	Non-small Cell Lung Cancer n=5 Participants 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.	Cervical Cancer n=3 Participants 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.	Other (Colorectal Cancer, Glioblastoma, Melanoma) n=4 Participants 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.
Overall Survival (OS)	NA months Median overall survival and the upper and lower limits of the 90% confidence interval (CI) were not estimable due to an insufficient number of events.	NA months Median overall survival and the upper and lower limits of the 90% CI were not estimable due to an insufficient number of events.	NA months Median overall survival and the upper and lower limits of the 90% CI were not estimable due to an insufficient number of events.	NA months Median overall survival and the upper and lower limits of the 90% CI were not estimable due to an insufficient number of events.

Adverse Events

Biliary Tract Cancer

Serious events: 3 serious events

Other events: 8 other events

Deaths: 1 deaths

Non-small Cell Lung Cancer

Serious events: 4 serious events

Other events: 3 other events

Deaths: 2 deaths

Cervical Cancer

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Other (Colorectal Cancer, Glioblastoma, Melanoma)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Communication Center

Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Biliary Tract Cancer n=10 participants at risk 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.	Non-small Cell Lung Cancer n=5 participants at risk 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.	Cervical Cancer n=3 participants at risk 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.	Other (Colorectal Cancer, Glioblastoma, Melanoma) n=4 participants at risk 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.
Blood and lymphatic system disorders Anaemia	10.0% 1/10 • Number of events 1 • 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)	0.00% 0/5 • 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)	0.00% 0/3 • 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)	0.00% 0/4 • 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)
Gastrointestinal disorders Diaphragmatic hernia	10.0% 1/10 • Number of events 1 • 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)	0.00% 0/5 • 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)	0.00% 0/3 • 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)	0.00% 0/4 • 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)
General disorders Death	0.00% 0/10 • 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)	20.0% 1/5 • Number of events 1 • 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)	0.00% 0/3 • 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)	0.00% 0/4 • 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)
General disorders Disease progression	0.00% 0/10 • 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)	20.0% 1/5 • Number of events 1 • 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)	0.00% 0/3 • 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)	0.00% 0/4 • 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)
Infections and infestations Abscess	0.00% 0/10 • 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)	20.0% 1/5 • Number of events 1 • 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)	0.00% 0/3 • 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)	0.00% 0/4 • 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)
Infections and infestations Cellulitis	0.00% 0/10 • 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)	0.00% 0/5 • 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)	0.00% 0/3 • 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)	25.0% 1/4 • Number of events 1 • 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)
Infections and infestations Coronavirus infection	0.00% 0/10 • 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)	0.00% 0/5 • 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)	33.3% 1/3 • Number of events 1 • 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)	0.00% 0/4 • 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)
Infections and infestations Influenza	0.00% 0/10 • 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)	0.00% 0/5 • 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)	0.00% 0/3 • 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)	25.0% 1/4 • Number of events 1 • 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)
Infections and infestations Pneumonia	0.00% 0/10 • 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)	20.0% 1/5 • Number of events 2 • 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)	0.00% 0/3 • 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)	0.00% 0/4 • 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)
Infections and infestations Sepsis	0.00% 0/10 • 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)	20.0% 1/5 • Number of events 2 • 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)	0.00% 0/3 • 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)	0.00% 0/4 • 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)
Infections and infestations Septic shock	0.00% 0/10 • 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)	20.0% 1/5 • Number of events 1 • 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)	0.00% 0/3 • 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)	0.00% 0/4 • 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)
Investigations Blood creatinine increased	0.00% 0/10 • 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)	20.0% 1/5 • Number of events 1 • 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)	0.00% 0/3 • 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)	0.00% 0/4 • 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)
Nervous system disorders Cerebral ischaemia	0.00% 0/10 • 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)	0.00% 0/5 • 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)	0.00% 0/3 • 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)	25.0% 1/4 • Number of events 1 • 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)
Nervous system disorders Seizure	0.00% 0/10 • 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)	0.00% 0/5 • 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)	0.00% 0/3 • 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)	25.0% 1/4 • Number of events 1 • 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)
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	10.0% 1/10 • Number of events 1 • 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)	0.00% 0/5 • 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)	0.00% 0/3 • 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)	0.00% 0/4 • 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)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/10 • 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)	0.00% 0/5 • 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)	0.00% 0/3 • 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)	25.0% 1/4 • Number of events 1 • 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)
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • 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)	20.0% 1/5 • Number of events 1 • 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)	0.00% 0/3 • 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)	0.00% 0/4 • 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)