Clinical trial · Interventional
Pembrolizumab and Radiotherapy for Patients With NK/T Cell Lymphoma
Pembrolizumab and Radiotherapy for Previously Untreated Patients With Limited Stage NK/T Cell Lymphoma Who Are Not Eligible to Chemotherapy
NCT04417166CI-TRIAL-00107448active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Extranodal NK-T-Cell | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Involved Field Radiation Therapy | Radiation | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pembrolizumab and Radiotherapy
- description
- Induction Phase: Standard Involved Field Radiation Therapy (IFRT) and pembrolizumab. Pembrolizumab 200 mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 6 cycles. IFRT will start at first cycle of Pembrolizumab and will be delivered concurrently. Patients with complete remission (CR), partial response (PR) and stable disease (SD) after Induction Phase will continue with pembrolizumab maintenance. Maintenance Phase: Pembrolizumab 200 mg IV will be given over 30 minutes on day 1 of each 21 day cycle up to 34 cycles or until disease progression or unaccepted toxicity
- interventionNames
- Drug: Pembrolizumab
- Radiation: Involved Field Radiation Therapy
Primary outcomes (1)
- measure
- 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
- description
- Response will be assessed using international criteria for response assessment in lymphomas (Cheson 2014) and their update for patients receiving checkpoint inhibitors (Cheson 2016 Lyric)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 infarction in the previous 3 months, unstable arrhythmias, or unstable angina. * Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent * HBsAg, HCV or HIV positivity. Positive serology is admitted for HBV and HCV but DNA/RNA test must be negative * Administration of a live attenuated vaccine within 4 weeks before cyle 1 day 1. Patients must not receive live, attenuate vaccines, including influenza vaccines at any time during study. * Treatment with systemic immunosuppressive medications, including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and anti tumor necrosis factor (anti-TNF) agents within 2 weeks prior to cycle 1 day 1; inhaled corticosteroids are allowed. * Evidence of suspect of CNS disease * Clinically significant hypersensitivity (e.g., anaphylactic or anaphylactoid reactions to the compound Pembrolizumab itself or to the excipients in its formulation). * Has had an allogenic tissue/solid organ transplant * Known history of active TB (Bacillus Tuberculosis)
References
Publications (0)
Data not yet available
No reference posted for this study.