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 range18 Years
SexALL
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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 ā„ 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 immunodefiā¦