AzTrials
AzTrials

Lymphoma, Extranodal NK-T-CellPhase 2NCT04417166

Pembrolizumab and Radiotherapy for Patients With NK/T Cell Lymphoma

A Phase 2 study testing Pembrolizumab and Involved Field Radiation Therapy in people with Lymphoma, Extranodal NK-T-Cell, run by International Extranodal Lymphoma Study Group (IELSG) at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Extranodal NK-T-Cell
What is being tested?
Pembrolizumab and Involved Field Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesChina
Study dates
11 Feb 2022to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • Shanghai Rui-Jin Hospital

    Shanghai, 200025

Other trials in China

About this study

Official title: Pembrolizumab and Radiotherapy for Previously Untreated Patients With Limited Stage NK/T Cell Lymphoma Who Are Not Eligible to Chemotherapy

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.

Read the detailed description

This is an interventional, phase II, open label, single arm, multicentric clinical trial to be conducted in China.

The primary objective is to test the efficacy of concurrent RT-Pembrolizumab in patients with limited stage NK/T cell lymphoma and who are not eligible to receive chemotherapy.

The secondary objectives are to further explore the efficacy and safety of a the combination of RT and Pembrolizumab as initial treatment of the patients population.

All eligible patients will be treated with standard IFRT and concurrent pembrolizumab administered intravenously, over 30 minutes starting on day 1 of RT (C1D1, at the dose of 200 mg, every 3 weeks). After 6 cycles of pembrolizumab patients will undergo restaging imaging. Patients with complete remission (CR), partial response (PR) and stable disease (SD) will continue with pembrolizumab maintenance up to 2 years that will be administered intravenously, at the dose of 200 mg, over 30 minutes on day 1 every 3 weeks up to 34 cycles.

The follow-up period will last up to 4 years from treatment start.

Being tested
Pembrolizumab, Involved Field Radiation Therapy
Medical subject headings
Lymphoma, Extranodal NK-T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called Keytruda

    50 mg powder for concentrate for solution for infusion

  • Involved Field Radiation TherapyRadiation

    50-54 Gy Involved Field Radiation Therapy (IFRT) as proposed by the International Lymphoma Radiation Oncology Group (ILROG) guidelines. 50 Gy is recommended in patients without primary tumor invasiveness (invasion to adjacent tissue and/or organs), 54 Gy in locally advanced cases (invasion to adjacent tissue and/or organs) or with other risk factors (age > 60 years, stage II, elevated serum LDH levels).

    Intensity modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT) are recommended but not mandatory; 3-dimensional conformal RT (3D-CRT) is allowed.

Study groups in NCT04417166
Study groupRoleWhat they receive
Pembrolizumab and RadiotherapyExperimentalInduction 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
Receives: Drug: Pembrolizumab; Radiation: Involved Field Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) rate at 2 years - The proportion of patients without disease progression after 2 years from treatment start

    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)

    Measured: 2 years from treatment start

Secondary outcomes (6)

  1. Complete remission rate (CRR) - Proportion of patients with complete responses

    CRR defined according to Cheson 2014 criteria

    Measured: After 4 months from treatment start (End of Induction phase), Maintenance Phase:every 4 months during the first year and then every 6 months until end of treatment. Follow up: every 4 months during first year, then every 6 months during second year

  2. 2-year Event-free survival - Proportion of patient without disease related events after 2 years from treatment start

    Measured: 2 years from treatment start

  3. Treatment related mortality - Number of treatment related deaths

    Measured: From informed consent signature to 90 days after the last study treatment administration

  4. 2-year Overall survival - Proportion of patients alive after 2 years from treatment start

    Measured: 2 years from treatment start

  5. Rate of adverse events - Analysis of incidence, severity and relationship of adverse events

    Adverse Events severity will be classified according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) V. 5.0

    Measured: From Informed Consent signature to 30 days for AEs or 90 for SAEs after end of treatment

  6. Overall Response Rate (ORR) - calculated as the sum of the complete and partial remission rates

    ORR defined according to Cheson 2014 criteria

    Measured: After 4 months from treatment start (End of Induction phase) Maintenance Phase: every 4 months during the first year and then every 6 months until end of treatment. Follow up: every 4 months during first year, then every 6 months during second year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start11 Feb 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04417166
Sponsor's protocol ID
IELSG50
Status last verified
Apr 2026
First submitted
2 Jun 2020
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Involved Field Radiation Therapy in people with Lymphoma, Extranodal NK-T-Cell, run by International Extranodal Lymphoma Study Group (IELSG) at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) rate at 2 years - The proportion of patients without disease progression after 2 years from treatment start (time frame: 2 years from treatment start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04417166.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in