A Phase I/II Study of the GRT-C901/GRT-R902 Vaccine plus Immunotherapy in People with Advanced Solid Tumors

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Full Title

An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination with Immune Checkpoint Blockade for Patients with Advanced Solid Tumors

Purpose

In this study, researchers are assessing the safety of a two-part vaccine, called GRT-C901 and GRT-R902, when given in combination with immunotherapy in patients with advanced solid tumors that contain adequate genetic changes (mutations). The study will assess different doses of GRT-R902 combined with GRT-C901, nivolumab, and ipilimumab to find the most effective dose.

The vaccination is designed to target tumors based on certain mutations in their cancer cells, thereby helping the immune system to recognize and attack cancer cells more effectively. The researchers believe that after immune cells have been “trained” by the vaccination to recognize cancer cells, they will “remember” and continue to target these cells. Nivolumab and ipilimumab are immunotherapy drugs that boost the immune system’s ability to fight cancer.

The vaccination is given as an injection into the muscle, nivolumab is given intravenously (by vein), and ipilimumab in this study is given as a subcutaneous (under the skin) injection.

Eligibility

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

  • Patients must have advanced or metastatic non-small cell lung cancer, stomach/esophageal cancer, colorectal cancer, or bladder cancer with enough adequate genetic mutations.
  • Patients should recover from the serious side effects of previous treatments before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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. Steven Maron at 646-888-6780.

Protocol

20-020

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators