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NCT04789668 · ClinicalTrials.gov registry record · Phase 1
Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04789668: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT04789668 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04789668, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This phase I/II trial studies the best dose and effect of pimasertib in combination with bintrafusp alfa in treating patients with cancer that has spread to the brain (brain metastases). Immunotherapy with bintrafusp alfa, a bifunctional fusion protein composed of the monoclonal antibody anti-PD-L1 and TGF-beta, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pimasertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pimasertib and bintrafusp alfa may help to prevent or delay the cancer from progressing (getting worse) and/or coming back.
Primary Outcome
Establish safety profile and recommended phase II dose for combining pimasertib with bintrafusp alfa (M7824) in patients with brain metastases.
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Bintrafusp Alfa
- DRUG Pimasertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-01-15 |
| Est. Completion | 2023-12-08 |
| Phase | Phase 1 |
Why NCT04789668 stopped before completion
NCT04789668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04789668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04789668 about?
NCT04789668 is a clinical study titled "Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases". This phase I/II trial studies the best dose and effect of pimasertib in combination with bintrafusp alfa in treating patients with cancer that has spread to the brain (brain metastases). Immunotherapy with bintrafusp alfa, a bifunctional fusion protein composed of the monoclonal antibody anti-PD-L1 ...
What is the current status of trial NCT04789668?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-01-15. Estimated completion is 2023-12-08.
What interventions are being tested in trial NCT04789668?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Bintrafusp Alfa (DRUG), Pimasertib (DRUG).
Who is sponsoring clinical trial NCT04789668?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04789668's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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