Clinical Trial: Pembrolizumab In Central Nervous System Metastases

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Trial of Pembrolizumab in Central Nervous System Metastases From Multiple Histologies

Brief Summary: This research study is studying Pembrolizumab as a possible treatment for this diagnosis for metastases in the central nervous system (brain and spinal cord).

Detailed Summary:

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.


Sponsor: Massachusetts General Hospital

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: August 29, 2016
Date Started: October 2016
Date Completion: January 2024
Last Updated: March 3, 2017
Last Verified: March 2017