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Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases

NCT04789668 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-03-18

Study results available
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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.

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

Interventions

DRUG

Bintrafusp Alfa

Given IV

DRUG

Pimasertib

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Hussein A Tawbi, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2023-12-08
Completion
2023-12-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04789668 on ClinicalTrials.gov