Pembrolizumab In Central Nervous System Metastases (NCT02886585) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pembrolizumab In Central Nervous System Metastases
United States101 participantsStarted 2016-10
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have histologically or cytologically confirmed disease from any solid tumor
* Participants must have measurable disease in the CNS, defined as at least one lesion that can be accurately measured in at least one dimension as ≥5 mm .
* Age ≥18 years.
* ECOG performance status ≤ 2 (Karnofsky ≥60%, see Appendix A)
* Life expectancy of greater than 6 weeks
* Participants must have normal organ and marrow function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
* Adequate Organ Function Laboratory Values
* Hematological
\---- Absolute neutrophil count (ANC) ≥1,500 /mcL
\---- Platelets ≥100,000 / mcL
\---- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
* Renal
\---- Serum creatinine ≤1.5 X upper limit of normal (ULN)
\----- OR
\---- Measured or calculated a creatinine clearance ≥60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN (GFR can also be used in place of creatinine or CrCl)
* Hepatic
\---- Serum total bilirubin ≤ 1.5 X ULN
\----- OR
\---- Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN
\---- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN
\----- OR
\---- ≤ 5 X ULN for subjects with liver metastases
* Albumin \>2.5 mg/dL
* Coagulation ---- International Normalized Ratio (INR) or Prothr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intracranial Benefit Rate (Cohorts A and B)
Timeframe: 44 months
2
Overall Survival at Three Months (Cohort C)
Timeframe: 3 Months
3
Extracranial Overall Response Rate (Cohort D)
Timeframe: Data collection is ongoing for this objective. The longest time a single patient has been followed for this measure is 6 years.