A Phase I Study of Olaratumab plus Pembrolizumab Immunotherapy to Treat Inoperable or Metastatic Soft Tissue Sarcoma

Full Title

I5B-MC-JGDQ(a): An Open-Label, Multicenter, Phase 1a/1b Study of Olaratumab (LY3012207) Plus Pembrolizumab (MK3475) in Patients with Unresectable Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Failed Standard Treatments

Purpose

The purpose of this study is to determine the optimal dose and preliminary effectiveness of the combination of olaratumab and pembrolizumab immunotherapy in patients with inoperable or metastatic soft tissue sarcoma that has continued to grow despite standard treatment.

Olaratumab is an antibody that blocks a biochemical pathway which fuels the growth of sarcoma cells. Pembrolizumab is an immunotherapy drug which blocks PD-1, a protein cancer cells use to evade detection by the immune system, thereby enabling the immune system to find and kill cancer cells. The use of these two drugs together in this study is considered investigational. Both drugs are 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 inoperable or metastatic soft tissue sarcoma that has continued to grow despite standard treatment.
  • Patients may have previously received olaratumab, but prior treatment with immunotherapy drugs that target PD-1, PD-L1, or other immune system checkpoint proteins is not permitted.
  • 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 Dr. William Tap at 646-888-4163.

Protocol

17-325

Phase

I

Investigator

Co-Investigators