Pembrolizumab for Brain Tumor

Recruiting in Palo Alto (17 mi)

+1 other location

Priscilla Brastianos | Breast Cancer ...

Overseen byPriscilla K. Brastianos

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This research study is studying Pembrolizumab as a possible treatment for this diagnosis for metastases in the central nervous system (brain and spinal cord).

Eligibility Criteria

This trial is for adults with confirmed solid tumor metastases in the brain or spinal cord. Participants must have a measurable lesion, be in good physical condition (ECOG ≤2), and have a life expectancy over 6 weeks. Specific cohorts include untreated asymptomatic brain metastases, carcinomatous meningitis, and melanoma with limited brain metastases suitable for radiosurgery.

Inclusion Criteria

You must have a confirmed diagnosis of cancer from a tissue sample or cells.

You must have a detectable brain tumor that can be accurately measured and is at least 5 millimeters in size.

Age ≥18 years

+14 more

Exclusion Criteria

Participants who are receiving any other investigational agents

You need to have surgery or radiation treatment for brain metastases right away.

You have had chemotherapy or other specific treatments within the last 14 days, or you have not fully recovered from side effects of previous treatments.

+19 more

Participant Groups

The study tests Pembrolizumab's effectiveness on central nervous system metastases from various tumors. It includes MRI and PET/CT imaging to track changes, along with Stereotactic Radiosurgery for certain patients. The trial has multiple cohorts based on different disease characteristics.

4Treatment groups

Experimental Treatment

Group I: Progressive Brain Metastases-Cohort BExperimental Treatment3 Interventions

- Progressive Brain Metastases * Baseline Brain MRI and PET CT * For all cohorts, pembrolizumab will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle. Treatment will be administered on an outpatient basis. * Brain MRI and PET/CT

Group II: Previously Untreated Brain Metastases-Cohort AExperimental Treatment3 Interventions

- Previously Untreated Brain Metastases * Baseline Brain MRI and PET CT * For all cohorts, pembrolizumab will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle. Treatment will be administered on an outpatient basis. * Brain MRI and PET/CT

Group III: Neoplastic Meningitis-Cohort CExperimental Treatment3 Interventions

* Neoplastic Meningitis * Histologically confirmed solid malignancy * Positive Cytology * Baseline Brain MRI * For all cohorts, pembrolizumab will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle. Treatment will be administered on an outpatient basis. * Brain MRI and PET/CT

Group IV: 1-4 Brain Metastases from Melanoma Cohort DExperimental Treatment4 Interventions

* 1-4 Brain Metastases from Melanoma * Clinical indication for stereostatic radiosurgery * Evaluable extracranial focus * For all cohorts, pembrolizumab will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle. In Cohort D, cycle 1 and 2 of pembrolizumab will be administered 3 weeks apart and stereotactic radiosurgery will be administered between cycles. Treatment will be administered on an outpatient basis. * Brain MRI and PET CT

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: