Pembrolizumab In Central Nervous System Metastases
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|ClinicalTrials.gov Identifier: NCT02886585|
Recruitment Status : Recruiting
First Posted : September 1, 2016
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Drug: Pembrolizumab Radiation: MRI Radiation: PET/CT Procedure: Stereotactic Radiosurgery||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
Pembrolizumab may help the immune system fight cancer.
The FDA (the U.S. Food and Drug Administration) has approved pembrolizumab FDA for some diseases that are being treated on this study, but not for central nervous system metastases. Researchers hope to study the effects of pembrolizumab. Many cancers use specific pathways (such as PD-1/PD-L1 and CTLA-4) to evade the body's immune system. Pembrolizumab works by blocking the PD-1/PD-L1 pathways and thus releasing the brakes on the immune system so it can stop or slow cancer.
Researchers hope to study the effects of pembrolizumab in cancer that has metastasized to the brain. These drugs work by stimulating the immune system to fight cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Pembrolizumab in Central Nervous System Metastases From Multiple Histologies|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||January 2024|
Experimental: Previously Untreated Brain Metastases-Cohort A
- Previously Untreated Brain Metastases
Experimental: Progressive Brain Metastases-Cohort B
- Progressive Brain Metastases
Experimental: Neoplastic Meningitis-Cohort C
Experimental: 1-4 Brain Metastases from Melanoma Cohort D
Procedure: Stereotactic Radiosurgery
- Objective Response Rate [ Time Frame: 6 Weeks ]Contrast-enhanced cranial MRI will be performed every 6 weeks. The proportion of patients in each cohort with a best response of CR or PR will be presented with a 90% confidence interval estimated using the method of Atkinson and Brown, which allows for the two-stage design.
- Overall Survival Rate [ Time Frame: 3 Months ]Any patient whose vital status is unknown due to loss of follow-up will be classified as having died for purposes of estimating the primary endpoint. The proportion of patients alive at six months will be summarized with a 90% confidence interval estimated using the method of Atkinson and Brown, which allows for the two-stage design.
- Extracranial Overall Response Rate [ Time Frame: 3 Months ]The proportion of patients with a best extracranial response of CR or PR will be presented with a 90% confidence interval estimated using the method of Atkinson and Brown, which allows for the two-stage design.
- Number of Participants with grade-3 or higher hematologic toxicities or grade-3 or higher neurologic toxicities [ Time Frame: Baseline to 21 Days ]
- Overall Survival Rate [ Time Frame: 3 Months and 6 Months ]Kaplan-Meier
- Intracranial Response Rate [ Time Frame: 6 Months ]intracranial response (CR or PR by RANO) will be presented with a two-sided, 90% exact binomial confidence interval
- Extracranial Response Rate [ Time Frame: 6 Months ]Extracranial response rates (CR or PR) according to RECIST and irRC will be summarized for Cohorts A, B, C, and D
- Extracranial PFS [ Time Frame: 3 Months and 6 Months ]
- Intracranial PFS [ Time Frame: 3 Months and 6 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886585
|Contact: Priscilla Brastianos, MD||617-724-8770|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02114|
|Contact: Priscilla Brastianos, MD 617-724-8770|
|Principal Investigator: Priscilla Brastianos, MD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Eudocia Lee, MD 617-632-2166|
|Principal Investigator: Eudocia Lee, MD|
|Principal Investigator:||Priscilla Brastianos, MD||Massachusetts General Hospital|