Study on the Safety and Effectiveness of Pembrolizumab with Hyaluronidase for Treating Relapsed or Refractory Hodgkin Lymphoma and Primary Mediastinal Large B-cell Lymphoma
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06504394
This clinical trial is testing a new formulation of the drug pembrolizumab, combined with hyaluronidase, to see how it works in patients with Hodgkin Lymphoma or Primary Mediastinal Large B-cell Lymphoma that has returned or not responded to previous treatments.
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Program Overview
The main goal of this study is to understand how the drug pembrolizumab, when combined with hyaluronidase and given as an injection under the skin, behaves in the body and how effective it is in treating adults with relapsed or refractory Classical Hodgkin Lymphoma (rrcHL) or Primary Mediastinal Large B-cell Lymphoma (rrPMBCL). The study does not aim to test a specific hypothesis but rather to gather information on the drug's effects.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with classical Hodgkin lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL).
- Have cancer that can be measured by scans.
- Expected to live for more than 3 months.
- If HIV-positive, must have well-controlled HIV with antiretroviral therapy.
- If positive for hepatitis B, must have been on antiviral therapy for at least 4 weeks and have no detectable virus before joining the study.
- If previously infected with hepatitis C, must have completed treatment at least 4 weeks before joining and have no detectable virus.
- Must be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have significant heart disease.
- Have fluid buildup around the heart or lungs that is causing symptoms.
- Have another cancer that is getting worse or needed treatment in the last 2 years.
- Have an immune system deficiency or are taking medications that suppress the immune system.
- Have received certain antibody treatments or cancer therapies recently and have not recovered from their side effects.
- Have had treatments targeting specific immune checkpoints like PD-1, PD-L1, or PD-L2.
- Have had radiation therapy recently and have side effects requiring steroids.
- Have received a live vaccine recently.
- Are receiving other cancer treatments not specified in the study.
- Have cancer that has spread to the brain or spinal cord.
- Have an active autoimmune disease needing treatment in the last 2 years.
- Have a history of lung inflammation needing steroids or have current lung disease.
- Have an active infection needing treatment.
- Have both active hepatitis B and C infections.
- Have had a solid organ transplant or a stem cell transplant in the last 5 years.
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