Pembrolizumab in Relapsed or Refractory Extranodal NK/T- Cell Lymphoma, Nasal Type and EBV-associ… (NCT03586024) | Clinical Trial Compass
WithdrawnPhase 1/2
Pembrolizumab in Relapsed or Refractory Extranodal NK/T- Cell Lymphoma, Nasal Type and EBV-associated Diffuse Large B Cell Lymphomas
Stopped: poor accrual
United States0Started 2019-03-12
Plain-language summary
To determine the safety and efficacy (overall response rate) of pembrolizumab in patients with relapsed or refractory ENKTL, and EBV-DLBCL
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:
* Be willing and able to provide written informed consent/assent for the trial.
* Be ≥ 18 years of age on day of signing informed consent.
* Have measurable disease based on defined as at least one lesion that can be accurately measured in at least two dimensions with a spiral CT scan, PET/CT scan, or MRI. Minimum measurement of \>1.5 cm in longest diameter by \> 1.0 cm in short axis.
* Have a performance status of 0 or 1 on the ECOG Performance Scale.
* Demonstrate adequate organ function, all screening labs should be performed within 10 business days of treatment initiation with the exception of beta-HCG (72 hours), if applicable.
* Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication.
* Male subjects of childbearing potential (Section 5.7.1) must agree to use an adequate method of contraception as outlined in Section 5.7.1- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Exclusion Criteria:
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of first dose of treatment or used an investigational device within 4 weeks of the first dose of treatment.
* Has a diagnosis of immunodefi…
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.