A Phase I/II Study of GRT-C903/GRT-R904 Vaccination plus Immunotherapy in People with Advanced Solid Tumors

Full Title

A Phase 1/2 Study of GRT-C903/GRT-R904, a Vaccine Targeting Shared Neoantigens, in Combination with Immune Checkpoint Blockade for Patients with Advanced Solid Tumors

Purpose

The purpose of this study is to determine if a two-part vaccination is safe and effective for treating metastatic cancer when combined with nivolumab and ipilimumab immunotherapy. The vaccination is made up of two parts: an initial dose of GRT-C903 followed by monthly injections of GRT-R904. The study will evaluate different doses of GRT-R904 combined with GRT-C903, nivolumab, and ipilimumab to find the most effective dose that can be given safely.

The vaccination is designed to target tumors with certain genetic mutations, which helps the immune system recognize and attack the cancer cells more effectively. The researchers think that after the 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; they boost the immune system’s ability to fight cancer.

The vaccination is given as injections into the muscle and nivolumab is given intravenously (by vein). Ipilimumab will be 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 a solid tumor that has metastasized and contains certain mutations in one of these gene families: BRAF, CTNNB1, ERBB2, KRAS, and TP53.
• Patients should recover from the serious side effects of prior therapies 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 and to inquire about eligibility for this study, please contact Dr. Chrisann Kyi at 646-888-4221.