22 Participants Needed

Pembrolizumab + Radiation Therapy for Hodgkin's Lymphoma

Recruiting at 8 trial locations
AM
JY
Overseen ByJoachim Yahalom, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy, targeted therapy, or radiation within 2 weeks before starting the trial, and you should not be on systemic steroid therapy or immunosuppressive therapy within 7 days before the trial begins.

What data supports the effectiveness of the treatment Pembrolizumab + Radiation Therapy for Hodgkin's Lymphoma?

Research shows that pembrolizumab, a drug that helps the immune system fight cancer, is effective in treating relapsed or hard-to-treat Hodgkin's Lymphoma, leading to high response rates and longer periods without disease progression. Additionally, studies suggest that combining radiation therapy with pembrolizumab may enhance the immune response against tumors, as seen in other cancers like non-small-cell lung cancer.12345

Is the combination of Pembrolizumab and Radiation Therapy generally safe for humans?

Pembrolizumab, used in cancer treatment, can cause immune-related side effects like fatigue, nausea, and thyroid issues. When combined with radiation therapy, it may increase the risk of immune-related adverse events, such as immune thrombocytopenia (a condition where the immune system attacks platelets, leading to bleeding).16789

How is the drug pembrolizumab combined with radiation therapy unique for treating Hodgkin's lymphoma?

Pembrolizumab is unique because it is an immune checkpoint inhibitor that helps the body's immune system attack cancer cells by blocking the PD-1 pathway, which is often overactive in Hodgkin's lymphoma. When combined with radiation therapy, which can also modify the immune environment, it may enhance the overall anti-tumor response, offering a new approach for patients who have not responded to other treatments.34101112

What is the purpose of this trial?

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.

Research Team

Alison J. Moskowitz, MD - MSK Lymphoma ...

Alison Moskowitz, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with early stage classical Hodgkin lymphoma that has either come back or didn't respond to initial treatment. They should have had only one prior therapy, be in good health with proper organ function, and not have active infections like HIV or hepatitis. Women of childbearing age must test negative for pregnancy and agree to contraception.

Inclusion Criteria

I was initially diagnosed with early stage cancer, treated with chemotherapy, and my cancer did not fully respond but hasn't grown larger than 10 cm.
Hematologic criteria: ANC ≥1,000 /mcL, Platelets ≥75,000 / mcL, Hemoglobin ≥8 g/dL
My kidney function, measured by creatinine or GFR, is within the required range.
See 10 more

Exclusion Criteria

I have not received a live vaccine in the last 30 days.
I have received more than one treatment for Hodgkin lymphoma.
I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab 200mg IV on day 1 of each 21-day cycle for a total of 4 cycles

12 weeks
4 visits (in-person)

Radiation

Participants receive involved site radiotherapy (ISRT) based on PET/CT results and biopsy outcomes

2-3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Involved Site Radiation Therapy
  • Pembrolizumab
Trial Overview The study tests pembrolizumab (a drug that helps the immune system fight cancer) followed by involved site radiation therapy (targeted radiation). It aims to see if this combo can cure relapsed/refractory Hodgkin lymphoma without the side effects of extensive chemotherapy or stem cell transplant.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab and Involved Site Radiation TherapyExperimental Treatment2 Interventions
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.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
  • Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Cervical cancer
  • Endometrial carcinoma
🇪🇺
Approved in European Union as KEYTRUDA for:
  • Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Cervical cancer
  • Endometrial carcinoma
🇬🇧
Approved in United Kingdom as KEYTRUDA for:
  • Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Findings from Research

In a study of 98 patients with advanced non-small-cell lung cancer (NSCLC), those who had previously received radiotherapy experienced significantly longer progression-free survival (4.4 months) and overall survival (10.7 months) when treated with pembrolizumab compared to those without prior radiotherapy.
The safety profile was acceptable, with similar rates of severe pulmonary toxicity between patients who had and had not received thoracic radiotherapy, suggesting that combining radiotherapy with pembrolizumab may be a beneficial treatment strategy for NSCLC.
Previous radiotherapy and the clinical activity and toxicity of pembrolizumab in the treatment of non-small-cell lung cancer: a secondary analysis of the KEYNOTE-001 phase 1 trial.Shaverdian, N., Lisberg, AE., Bornazyan, K., et al.[2022]
In a study of 55 patients with relapsed/refractory Hodgkin's Lymphoma, Pembrolizumab showed a high response rate of 74.5%, with a complete response in 32.7% of patients, indicating its efficacy before autologous stem cell transplantation.
The 12-month overall survival rate was 92%, and the progression-free survival rate was 51%, demonstrating reasonable safety and promising survival outcomes for patients treated with checkpoint inhibitors.
Pembrolizumab for the Treatment of Relapsed and Refractory Classical Hodgkin Lymphoma After Autologous Transplant and in Transplant-Naïve Patients.Halahleh, K., Al Sawajneh, S., Saleh, Y., et al.[2022]
In a phase 2 study involving 216 patients with stage III non-small cell lung cancer (NSCLC), the combination of pembrolizumab and concurrent chemoradiation therapy (cCRT) showed a high objective response rate of approximately 70.5% in cohort A and 70.6% in cohort B, indicating strong antitumor activity.
The treatment was associated with manageable safety, with grade 3 or higher pneumonitis occurring in 8.0% of cohort A and 6.9% of cohort B, suggesting that while there are risks, the benefits of this treatment approach may outweigh them for patients with locally advanced NSCLC.
Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer: The Phase 2 KEYNOTE-799 Nonrandomized Trial.Jabbour, SK., Lee, KH., Frost, N., et al.[2022]

References

Previous radiotherapy and the clinical activity and toxicity of pembrolizumab in the treatment of non-small-cell lung cancer: a secondary analysis of the KEYNOTE-001 phase 1 trial. [2022]
Pembrolizumab for the Treatment of Relapsed and Refractory Classical Hodgkin Lymphoma After Autologous Transplant and in Transplant-Naïve Patients. [2022]
Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer: The Phase 2 KEYNOTE-799 Nonrandomized Trial. [2022]
Pembrolizumab versus the standard of care for relapsed and refractory classical Hodgkin's lymphoma progressing after brentuximab vedotin: an indirect treatment comparison. [2019]
Pembrolizumab with or without radiotherapy for metastatic non-small-cell lung cancer: a pooled analysis of two randomised trials. [2021]
Pembrolizumab-related Immune Thrombocytopenia in a Patient with Lung Adenocarcinoma Treated by Radiotherapy: Potential Immune-related Adverse Event Elicited by Radiation Therapy. [2022]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Phase II Study of the Efficacy and Safety of Pembrolizumab for Relapsed/Refractory Classic Hodgkin Lymphoma. [2022]
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
Immune biomarkers of treatment failure for a patient on a phase I clinical trial of pembrolizumab plus radiotherapy. [2022]
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