Combining Pembrolizumab with Radiotherapy for NK/T Cell Lymphoma
Pembrolizumab and Radiotherapy for Previously Untreated Patients With Limited Stage NK/T Cell Lymphoma Who Are Not Eligible to Chemotherapy
This study is testing if combining a drug called Pembrolizumab with radiation therapy can help people with early-stage NK/T cell lymphoma who can't have chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | International Extranodal Lymphoma Study Group (IELSG) Academic / other |
| Drugs / interventions | Pembrolizumab, chemotherapy, methotrexate, cyclophosphamide, prednisone |
| Locations | 2 sites (Guangzhou and 1 other locations) |
| Trial ID | NCT04417166 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of Pembrolizumab, an anti-PD1 agent, in combination with radiotherapy for patients with limited stage NK/T cell lymphoma who cannot receive chemotherapy. The study plans to enroll 30 patients across multiple sites in China, administering Pembrolizumab intravenously every three weeks alongside standard radiotherapy. After six cycles, patients showing complete or partial responses will continue receiving Pembrolizumab for up to two years. The trial aims to follow patients for up to four years to assess long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of limited stage NK/T cell lymphoma and specific high-risk features.
Not a fit: Patients with advanced stage NK/T cell lymphoma or those who have previously received anti-lymphoma treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with NK/T cell lymphoma who are ineligible for chemotherapy.
How similar studies have performed: While the combination of immunotherapy and radiotherapy is being explored in various cancers, this specific approach for NK/T cell lymphoma is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Guangzhou and 1 other locations
- Sun Yat-sen University Cancer Center — Guangzhou, China (Recruiting)
- Shanghai Rui-Jin Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Emanuele Zucca, MD
- Email: ielsg@ior.usi.ch
- Phone: +41 58 666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.