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# Merck Pauses Keytruda Trial Enrollment to Study Deaths
- URL: https://www.fdaweb.com/merck-pauses-keytruda-trial-enrollment-to-study-deaths/
- Published: 2017-06-13T12:00:00.000Z
- Updated: 2026-09-14T22:29:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138917

Based on a data monitoring committee recommendation, Merck has paused new enrollment on KEYNOTE-183 and KEYNOTE-185, two studies exploring Keytruda (pembrolizumab) treatment in combination with other therapies in multiple myeloma. “The pause is to allow for additional information to be collected to better understand more reports of death in the Keytruda groups,” the company says. Patients currently enrolled in the studies will continue to receive treatment, and other studies involving Keytruda are unaffected.

KEYNOTE-183 is a Phase 3 study comparing pomalidomide and low-dose dexamethasone with Keytruda to pomalidomide and low-dose dexamethasone alone in patients with refractory or relapsed and refractory multiple myeloma who have undergone at least two lines of prior treatment. KEYNOTE-185 is a Phase 3 study comparing lenalidomide and low-dose dexamethasone with Keytruda to lenalidomide and low-dose dexamethasone alone in patients with newly diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell transplant.

Keytruda is currently indicated for treating patients with unresectable or metastatic melanoma at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity. It is also approved for treating lung cancer and head and neck cancer.