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

NCT03179917 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 17-054
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 9

Brief 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 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.

Conditions

Hodgkin Lymphoma

Keywords

Pembrolizumab; Radiation Therapy; 17-054

Outcome Measures

Primary Outcomes (1)

• complete response rate

  2 years

Study Arms (1)

Pembrolizumab and Involved Site Radiation Therapy

EXPERIMENTAL

Following 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.

Drug: Pembrolizumab; Radiation: Involved Site Radiation Therapy

Interventions

Pembrolizumab DRUG

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.

Pembrolizumab and Involved Site Radiation Therapy

Involved Site Radiation Therapy RADIATION

30 Gy of ISRT

Pembrolizumab and Involved Site Radiation Therapy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Three populations of patients are eligible for enrollment:
• (1) 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).
• (2) 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.
• (3) 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (9)

University of Miami

Miami, Florida, 33136, United States

Location

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

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

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Hodgkin Disease

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Alison Moskowitz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This phase II study will use an optimal Simon two-stage design.

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 7, 2017
• Study Start: June 8, 2017
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (9)