Pembrolizumab and Radiotherapy for Patients With NK/T Cell Lymphoma (NCT04417166) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pembrolizumab and Radiotherapy for Patients With NK/T Cell Lymphoma
China30 participantsStarted 2022-02-11
Plain-language summary
Aim of the trial is to evaluate the activity and tolerability of the anti PD1 agent Pembrolizumab in combination with RadioTherapy for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma who are not eligible to chemotherapy.
It is planned to enroll 30 patients in chinese sites.
All eligible patients will be treated with standard radiotherapy and concurrent pembrolizumab administered intravenously every 3 weeks. After 6 cycles of pembrolizumab patients with complete remission, partial response and stable disease will continue with pembrolizumab maintenance up to 2 years.
Patients will be followed up to 4 years from treatment start.
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:
* Confirmed histological diagnosis of NK/T Cell Lymphoma
* No previous anti-lymphoma treatment
* Age ≥ 18 years
* Ann Arbor stage I-II
* At least one measurable/evaluable site after diagnostic biopsy before treatment start
* At least one of the following high-risk features: age \> 60 years, elevated LDH, stage II, primary tumor invasion
* Patient ineligible to receive full dose standard chemotherapy
* ECOG performance status of 0-1
* Signed Informed consent
* Ability to comply with the protocol
* Adequate hematological and organ function;
* Tumor tissue (fresh preferred, archival tissue is also acceptable)
* For women of childbearing potential a negative pregnancy test on day 1 of cycle 1 and agree to adopt an adequate measure to avoid pregnancy during study treatment and for at least one year from end of treatment
* For men agreement to remain abstinent or to use barrier contraception
Exclusion Criteria:
* Advanced stage disease (AA stage III-IV)
* Extranasal type NKTCL
* History of autoimmune disease
* History of other(s) infiltrating cancer(s) in the previous 3 years that were not treated with curative intent or who are still receiving anticancer therapy (including hormone therapy for breast or prostate cancer).
* History of (non-infectious) pneumonitis that required steroids; evidence of interstitial lung disease or active, non-infectious pneumonitis
* Active infection requiring systemic therapy
* Significant cardiovascular disease, myocardial infar…
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
Progression Free Survival (PFS) rate at 2 years - The proportion of patients without disease progression after 2 years from treatment start
Timeframe: 2 years from treatment start
Trial details
NCT IDNCT04417166
SponsorInternational Extranodal Lymphoma Study Group (IELSG)