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Hodgkin LymphomaPhase 2NCT03179917

Pembrolizumab and Involved Site Radiation Therapy for Early Stage Relapsed or Primary Refractory Hodgkin Lymphoma

A Phase 2 study testing Pembrolizumab and Involved Site Radiation Therapy in people with Hodgkin Lymphoma, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.

Active, not recruiting

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

Official record
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Trial summary

This study is being done to test the safety and effectiveness of pembrolizumab followed by radiation therapy in Hodgkin lymphoma. The purpose of this study is to determine how effective combining the research drug, pembrolizumab, with a targeted form of radiation therapy known as involved site radiotherapy can be in… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Pembrolizumab and Involved Site Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
9 sitesUnited States
Study dates
8 Jun 2017to Jun 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Three populations of patients are eligible for enrollment:
  • Patients with early stage disease at diagnosis (stage I-II) who were treated with chemotherapy alone and relapsed with early stage disease (stage RI-II).
  • Patients with early stage disease at diagnosis (stage I-II) who were treated with chemotherapy alone and have early stage (stage RI-II) primary refractory disease (residual disease on a scan 1 month after the completion of initial therapy) without B-symptoms and with each area of disease less than 10 cm in size.
  • Patients with early stage disease at diagnosis (stage I-II) who were treated with combined modality therapy (chemotherapy and radiation) who relapse with early stage disease (stage RI-II) outside the prior radiation therapy field.
  • Histologic confirmation of classical Hodgkin Lymphoma after imaging documenting primary refractory or relapsed disease
  • Age 12 or older
Show all 22Show fewer
  • ECOG Performance Status of 0-1 or Lansky Performance Status of ≥ 50 (Pts 12-15 years of age)
  • Adequate organ function. Screening labs should be performed within 14 days of treatment initiation.
  • Hematologic
  • Absolute neutrophil count (ANC) ≥1,000 /mcL
  • Platelets* ≥75,000 / mcL
  • Hemoglobin* ≥8 g/dL Renal
  • Creatinine OR Measured or calculated** creatinine clearance CrCl (GFR can also be used in place of creatinine or ≤1.5 X upper limit of normal for age (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN Hepatic
  • Total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels >1.5 ULN
  • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for age for subjects with liver involvement Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy, then as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • 1.5 X ULN unless subject is receiving anticoagulant therapy, then as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Hemoglobin and platelet requirements cannot be met by use of recent transfusion or growth factor support (GCSF or erythropoietin) within 2 weeks prior to treatment initiation.
  • Creatinine clearance should be calculated per institutional standard.
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from sexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 5.7.2). Subjects of child bearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • Note: Abstinence is acceptable if this is the established and preferred contraception for the subject.
  • Male subjects should agree to use an adequate method of 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 established and preferred contraception for the subject.

Who cannot join

  • Ann Arbor Stage III or IV disease at diagnosis or at relapse/refractory disease confirmation.
  • Bulky disease (>10cm) at diagnosis or at relapse/refractory disease confirmation.
  • Active B symptoms.
  • Received >1 line of therapy for Hodgkin lymphoma
  • Relapsed/refractory disease within a prior radiation field.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
Show all 19Show fewer
  • Diagnosis of immunosuppression or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Has history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non infectious pneumonitis
  • Has an active infection requiring intravenous systemic therapy.
  • Has a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection
  • Has received a live vaccine or live attenuated vaccine within 30 days prior to first dose of study drug. Administration of killed vaccines is allowed
  • Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial
  • Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has had treatment a prior monoclonal antibody targeting PD-1, PD-L1, PD-L2, or CTLA-4.
  • Has a pre-treatment TTE showing a calculated left ventricular ejection fraction of less than 50%
  • Has a pre-treatment PFT showing an DLCO adjusted for hemoglobin of less than 60%
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Memorial Sloan Kettering at Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • University of Miami

    Miami, Florida, 33136

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Abramson Cancer Center at University of Pennsylvania (Data Collection Only)

    Philadelphia, Pennsylvania, 19104-4283

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

About this study

This study is being done to test the safety and effectiveness of pembrolizumab followed by radiation therapy in Hodgkin lymphoma.

The purpose of this study is to determine how effective combining the research drug, pembrolizumab, with a targeted form of radiation therapy known as involved site radiotherapy can be in patients with relapsed or refractory early stage classical Hodgkin lymphoma. The goal is to see whether this treatment strategy can cure a significant number of patients with relapsed or refractory early stage classical Hodgkin lymphoma while avoiding the toxicity of either a large radiation field or further chemotherapy and stem cell transplant.

Being tested
Pembrolizumab, Involved Site Radiation Therapy
Keywords
Pembrolizumab, Radiation Therapy, 17-054
Medical subject headings
Hodgkin Disease

What participants receive

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

  • PembrolizumabDrug

    pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Pediatric patients will be treated at 2 mg/kg with a maximum dose of 200 mg.

  • Involved Site Radiation TherapyRadiation

    30 Gy of ISRT

Study groups in NCT03179917
Study groupRoleWhat they receive
Pembrolizumab and Involved Site Radiation TherapyExperimentalFollowing a PET/CT simulation to evaluate the extent of disease, pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles. Fourteen to 21 days after the completion of therapy, a PET/CT simulation will be repeated. Pts with complete response will proceed to 20 Gy of ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these ps will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts without a PET CR, but improvement on CT scan will have a repeat biopsy. If the biopsy is negative for Hodgkin Lymphoma, these pts will receive 30 Gy of ISRT. If the biopsy is positive for Hodgkin Lymphoma, they will receive 36-40 Gy ISRT. Pts with new sites of disease or progression on imaging will have a repeat biopsy, per treating physician's discretion \& then be treated off study.
Receives: Drug: Pembrolizumab; Radiation: Involved Site Radiation Therapy

What is being measured

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

  1. Complete Response Rate Following Pembrolizumab-ISRT

    Complete response rate following Pembrolizumab-ISRT. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 2 years

  2. Overall Response Rate Following Single-agent Pembrolizumab

    Overall response rate following single-agent Pembrolizumab

    Measured: 2 years

  3. Complete Response Rate Following Single-agent Pembrolizumab

    Complete response rate following single-agent Pembrolizumab

    Measured: 2 years

  4. Progression Free Survival/PFS

    Overall Progression Free Survival/PFS at 2 Years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: 2 years

Timeline

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

  1. First posted7 Jun 2017
  2. Study start8 Jun 2017
  3. Primary completion15 Jun 2026
  4. Study completionJun 2027 (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
Model description
This phase II study will use an optimal Simon two-stage design.
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03179917
Sponsor's protocol ID
17-054
Status last verified
Jul 2026
First submitted
6 Jun 2017
Last updated
2 Sep 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Involved Site Radiation Therapy in people with Hodgkin Lymphoma, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.

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 22 inclusion and 19 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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?

Yes. Results are posted in the registry (first posted 2 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Complete Response Rate Following Pembrolizumab-ISRT (time frame: 2 years). The study lists 4 primary outcomes in all. 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 NCT03179917.

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 2 Sep 2026.

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