Bintrafusp alfa Program Rollover Study

An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Bintrafusp alfa (M7824) Clinical Studies - Bintrafusp alfa Program Rollover Study

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000179-36-ES

Enrollment

Registered

2021-08-25

Start date

2021-10-15

Completion date

Unknown

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer (NSCLC), biliary tract cancer (BTC), cervical cancer, and triple-negative breast cancer (TNBC) MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10073077 Term: Intrahepatic cholangiocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cyst

Interventions

Product Name: M7824 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: M7824 Current Sponsor code: M7824 Other descriptive name: MSB0011359C / Bintrafusp alfa Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Are = 18 years of age at the time of signing the informed consent. In Japan, if a participant is at least 18 but =65 years) yes F.1.3.1 Number of subjects for this age range 17

Exclusion criteria

Exclusion criteria: 1. Pregnancy or currently in lactation. 2. Known hypersensitivity to any of the study intervention ingredients. 3. For participants reinitiating treatment with bintrafusp alfa at study entry: have received any systemic anticancer therapies/treatments since discontinuing bintrafusp alfa treatment. 4. Concurrent treatment with prohibited drugs as indicated in the protocol. 5. Participant has withdrawn consent from the parent study for any reason. 6. Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate clinical safety of bintrafusp alfa in participants with solid tumors who continue treatment after completion of the primary/main analyses in parent bintrafusp alfa studies;Secondary Objective: To evaluate clinical efficacy of bintrafusp alfa based on overall survival;Primary end point(s): Occurrence of AEs and treatment-related AEs;Timepoint(s) of evaluation of this end point: Starting from baseline in parent study	—

Measure

Time frame

Main Objective: To evaluate clinical safety of bintrafusp alfa in participants with solid tumors who continue treatment after completion of the primary/main analyses in parent bintrafusp alfa studies;Secondary Objective: To evaluate clinical efficacy of bintrafusp alfa based on overall survival;Primary end point(s): Occurrence of AEs and treatment-related AEs;Timepoint(s) of evaluation of this end point: Starting from baseline in parent study

—

Secondary

Measure	Time frame
Secondary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Starting from baseline in parent study	—

Countries

Australia, Belgium, Brazil, China, France, Italy, Japan, Korea, Republic of, Spain, Turkey, Ukraine, United States

Contacts

Public ContactCommunication Center

Merck KGaA

service@merckgroup.com+34900 810 844

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026