Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases
Public ClinicalTrials.gov record NCT04789668. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/II Trial of BINTRAFUSP ALFA (M7824) and Pimasertib for Treatment of Intracranial Metastases
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04789668
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 8 participants
Conditions and interventions
Conditions
- Anatomic Stage IV Breast Cancer AJCC v8
- Clinical Stage IV Cutaneous Melanoma AJCC v8
- Hematopoietic and Lymphoid Cell Neoplasm
- Hormone Receptor Positive Breast Adenocarcinoma
- Metastatic Lung Non-Small Cell Carcinoma
- Metastatic Malignant Neoplasm in the Brain
- Metastatic Malignant Solid Neoplasm
- Metastatic Melanoma
- Metastatic Triple-Negative Breast Carcinoma
- Pathologic Stage IV Cutaneous Melanoma AJCC v8
- Prognostic Stage IV Breast Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
- Stage IVA Lung Cancer AJCC v8
- Stage IVB Lung Cancer AJCC v8
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 14, 2021
- Primary completion
- Dec 7, 2023
- Completion
- Dec 7, 2023
- Last update posted
- Mar 17, 2026
2021 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04789668, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 17, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04789668 live on ClinicalTrials.gov.