Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04789668
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2021-02-08
Brief Title:
Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Trial of BINTRAFUSP ALFA M7824 and Pimasertib for Treatment of Intracranial Metastases
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III 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 bodys 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 andor coming back
Detailed Description:
PRIMARY OBJECTIVES
I Establish safety profile and recommended phase II dose for combining pimasertib with bintrafusp alfa M7824 in patients with brain metastases Phase I
II Time to intracranial progression defined as progression of existing lesions and development of new lesions by modified Response Evaluation Criteria in Solid Tumors RECIST 11 Phase II
III Overall survival Phase II
SECONDARY OBJECTIVES
I Intracranial progression 6 12 and 18 months
II Intracranial objective response rate as measured by Response Assessment in Neuro-Oncology Brain Metastases RANO-BM immunotherapy iRANO and RECIST 11
III Time to second intracranial progression after salvage stereotactic radiosurgery SRS
IV Overall survival rate at 6 12 and 18 months
V Frequency of grade 3 intracranial toxicities at 4 weeks and 3 6 9 12 and 18 months
VI Frequency of extracranial progression and response rate at 8 weeks and 3 6 9 12 and 18 months
VII Frequency of neurocognitive decline at 6 12 and 18 months optional
VIII Changes in neurocognitive function and health-related quality of life
IX Dose duration and frequency of steroid use for symptomatic management
EXPLORATORY OBJECTIVES
I Identify molecular andor immunological markers from biospecimens tissue blood and cerebrospinal fluid CSF that are associated with treatment response and toxicity
II Identify imaging biomarkers of response and toxicity acute radiation effectradionecrosis and neurocognitive changes from multiparametric magnetic resonance imaging MRI andor delayed positron emission tomography PET that predict treatment response and toxicity
III Identify correlative or surrogative relationship between systemic blood and imaging markers and treatment outcomes
OUTLINE This is a phase I dose-escalation study of followed by a phase II dose-expansion study
Patients receive bintrafusp alfa intravenously IV over 1 hour every 2 weeks and pimasertib orally PO twice daily BID on days 1-28 Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 and 90 days every 6 weeks during year 1 and then every 12 weeks for up to 2 years
I Establish safety profile and recommended phase II dose for combining pimasertib with bintrafusp alfa M7824 in patients with brain metastases Phase I
II Time to intracranial progression defined as progression of existing lesions and development of new lesions by modified Response Evaluation Criteria in Solid Tumors RECIST 11 Phase II
III Overall survival Phase II
SECONDARY OBJECTIVES
I Intracranial progression 6 12 and 18 months
II Intracranial objective response rate as measured by Response Assessment in Neuro-Oncology Brain Metastases RANO-BM immunotherapy iRANO and RECIST 11
III Time to second intracranial progression after salvage stereotactic radiosurgery SRS
IV Overall survival rate at 6 12 and 18 months
V Frequency of grade 3 intracranial toxicities at 4 weeks and 3 6 9 12 and 18 months
VI Frequency of extracranial progression and response rate at 8 weeks and 3 6 9 12 and 18 months
VII Frequency of neurocognitive decline at 6 12 and 18 months optional
VIII Changes in neurocognitive function and health-related quality of life
IX Dose duration and frequency of steroid use for symptomatic management
EXPLORATORY OBJECTIVES
I Identify molecular andor immunological markers from biospecimens tissue blood and cerebrospinal fluid CSF that are associated with treatment response and toxicity
II Identify imaging biomarkers of response and toxicity acute radiation effectradionecrosis and neurocognitive changes from multiparametric magnetic resonance imaging MRI andor delayed positron emission tomography PET that predict treatment response and toxicity
III Identify correlative or surrogative relationship between systemic blood and imaging markers and treatment outcomes
OUTLINE This is a phase I dose-escalation study of followed by a phase II dose-expansion study
Patients receive bintrafusp alfa intravenously IV over 1 hour every 2 weeks and pimasertib orally PO twice daily BID on days 1-28 Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 and 90 days every 6 weeks during year 1 and then every 12 weeks for up to 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-1091 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-00219 | REGISTRY | None | None |