A Phase IB/II Study of Etigilimab with Nivolumab Immunotherapy in People with Solid Tumors

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Full Title

A Phase 1b/2 Open-Label Study of the Efficacy and Safety of Etigilimab (MPH313) Administered in Combination with Nivolumab to Subjects with Locally Advanced or Metastatic Solid Tumors

Purpose

The purpose of this study is to assess the safety and effectiveness of the immunotherapy drugs etigilimab and nivolumab given in combination in people with inoperable or metastatic cancers that continue to grow despite treatment. Etigilimab blocks a protein called TIGIT, which acts as a “brake” to stop immune cells from attacking tumors. Nivolumab blocks another immune system brake called PD-1. By blocking these proteins, each drug may release the brakes and allow the immune system to find and kill cancer cells.

Researchers think the combination of etigilimab and nivolumab may do a better job of boosting the immune system to kill cancer cells than either drug alone. Both medications are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have an inoperable or metastatic malignant solid tumor that has continued to grow despite treatment. Patient groups include those with endometrial cancer, cervical cancer, ovarian cancer, and rare tumors (sarcoma, uveal melanoma, and germ cell carcinoma).
  • Patients should recover from the serious side effects of previous therapies before receiving the study treatment.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Angela Green at 646-888-6792.

Protocol

21-335

Phase

I/II

Investigator

Co-Investigators