Pembrolizumab + Radiation Therapy for Hodgkin's Lymphoma
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 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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab 200mg IV on day 1 of each 21-day cycle for a total of 4 cycles
Radiation
Participants receive involved site radiotherapy (ISRT) based on PET/CT results and biopsy outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Involved Site Radiation Therapy
- Pembrolizumab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- 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
- 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
- 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