Phase 2 study of MK-3475A SC in rrcHL or rrPMBCL

• Research type

  Research Study

• Full title

  A Phase 2 Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) in Participants with Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)

• IRAS ID

  1010002

• Contact name

  - -

• Contact email

  -

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for other ways to treat classical Hodgkin lymphoma (cHL) and primary mediastinal large B-cell lymphoma (PMBCL) that is relapsed or refractory.

  Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Standard treatment for relapsed or refractory cHL and PMBCL is pembrolizumab given through a needle in a vein as an intravenous (IV) infusion. Giving pembrolizumab under the skin as a subcutaneous (SC) injection may make it easier to give and more convenient for people compared to an IV.

  The goal of this study is to learn what happens to pembrolizumab in a person’s body over time after they receive it as an SC injection. Researchers also want to learn how many people have the cancer respond to treatment.

  About 60 people with cHL or PMBCL will be in this study. They will be at least 18 years old and:
  • The cancer came back after or did not respond to certain treatments
  • Have not had treatment with IV pembrolizumab or similar immunotherapies that target PD-L1— PD-L1 is a type of protein found on cancer cells that can help the cancer hide from the body’s immune system
  Everyone in the study will receive pembrolizumab once every 6 weeks as an SC injection. They will receive pembrolizumab for about 2 years (18 treatments) unless the cancer gets worse or the person doesn’t tolerate it.

  Both the people in the study and the researchers will know which study treatment a person is getting because everyone will receive pembrolizumab (open-label study). During the study, people will give urine and blood samples, and have imaging tests and physical examinations.

  A person may be in this study for about 3 years.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  24/EE/0160

• Date of REC Opinion

  17 Sep 2024

• REC opinion

  Further Information Favourable Opinion