Study on the Safety and Effectiveness of Favezelimab and Pembrolizumab for Blood Cancers

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03598608

This clinical trial is testing a combination of two drugs, Favezelimab and Pembrolizumab, to see if they are safe and effective for treating certain blood cancers, including Hodgkin lymphoma and non-Hodgkin lymphoma. The study will also look at how each drug works on its own for Hodgkin lymphoma.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a combination of two drugs, Favezelimab (MK-4280) and Pembrolizumab (MK-3475), in treating certain blood cancers. These include classical Hodgkin lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL), and indolent non-Hodgkin lymphoma (iNHL). The study will also test each drug separately for Hodgkin lymphoma. The study is divided into two parts: a safety phase to find the best dose and an expansion phase to see how well the treatment works. There is no main hypothesis being tested in this study.

Eligibility Criteria

Inclusion Criteria

  • Have at least one tumor that can be measured accurately using scans like CT or MRI, with specific size requirements.
  • Be able to provide a tumor sample for analysis, either from a recent biopsy or a new one at the start of the study.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Have active cancer in the brain or spinal cord.
  • Have previously received certain types of cancer treatments, such as LAG-3 antibodies or CAR-T-cell therapy, for specific blood cancers.
  • Have had cancer treatment or chest radiation within 14 days before starting the study treatment.
  • Have significant side effects from previous treatments that have not improved.
  • Have received a monoclonal antibody treatment within 4 weeks before the study or have not recovered from its side effects.
  • Have received a live vaccine within 30 days before starting the study treatment.
  • Have used an experimental drug or device within 4 weeks before starting the study.
  • Have an immune system deficiency or are on long-term steroid or immunosuppressive therapy.
  • Have another active cancer that needs treatment, except for certain skin cancers or cervical cancer that has been treated.
  • Have an autoimmune disease that needed treatment in the past 2 years.
  • Have a history of lung inflammation that needed steroids or have current lung inflammation.
  • Have an active infection needing IV treatment.
  • Have a history of HIV, active hepatitis B, or hepatitis C.
  • Are pregnant, breastfeeding, or planning to have children during the study and for 120 days after the last treatment.
  • Have had a stem cell or organ transplant in the last 5 years.

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