DARMSTADT, Germany A mid-stage clinical trial program to investigate a Merck KGaA cancer vaccine has been put on hold due to patients’ experiencing adverse side effects, the German drug maker announced Tuesday.
Merck KGaA, which is separate from the U.S.-based Merck & Co. and operates in the United States under the name EMD, said it temporarily suspended recruitment and treatment of patients in the phase 2 trial for Stimuvax (BLP25 liposome vaccine) after a patient with the bone marrow cancer multiple myeloma developed encephalitis. Merck said it made its decision under in alignment with a Food and Drug Administration hold placed on its investigational new drug application for Stimuvax.
The patient who developed encephalitis, a potentially fatal inflammation of the brain, was in an experimental arm of the clinical program and taking Stimuvax in combination with low doses of the cancer drug cyclophosphamide, which was not used in the other Stimuvax studies.
Another program, a phase 3 trial involving patients with non-small cell lung cancer and breast cancer, is affected as well, though Merck did not say exactly how.