A Phase II Study of Pembrolizumab Immunotherapy in Patients with Advanced Solid Tumors with Many Mutations

Full Title

Phase 2 Study of MK-3475 in Patients with Microsatellite Unstable (MSI) Tumors

Purpose

Pembrolizumab is an immunotherapy drug used to treat several types of cancer. It inhibits a protein called PD-1, which cancer cells use to evade detection by the immune system, thereby enabling the immune system to find and kill cancer cells.

In this study, researchers are assessing the safety and effectiveness of pembrolizumab in patients with advanced solid tumors that contain a high total number of mutations in their tumor DNA. Pembrolizumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an inoperable or metastatic solid tumor that has a high total number of mutations in the tumor DNA. Patients’ tumors must be “microsatellite stable” (i.e., not have microsatellite instability, a defect in DNA repair).
  • Patients’ tumors must have continued to grow despite one prior regimen of therapy.
  • Patients may not have previously received a PD-1 inhibitor or other “checkpoint” inhibitor immunotherapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Luis Diaz at 646-888-4204.

Protocol

18-293

Phase

II

Investigator

Diaz, Luis, MD

Co-Investigators