The primary objective is to assess and characterize the antitumor activity and safety and
tolerability of adjuvant treatment with an individualized neoantigen vaccine called
GRT-C901/GRT-R902 (chimpanzee adenovirus [ChAd] and self-amplifying messenger RNA [samRNA]
vectors), in combination with checkpoint inhibitors. Antitumor activity will be based on
molecular response in patients with colon cancer who have circulating tumor deoxyribonucleic
acid (ctDNA) following surgical resection.
Tumors harboring non-synonymous deoxyribonucleic acid (DNA) mutations present peptides
containing these mutations as non-self antigens in the context of human leukocyte antigens
(HLAs) on the tumor cell surface. A fraction of mutated peptides results in neoantigens
capable of generating T cell responses that exclusively target tumor cells. Sensitive
detection of these mutations allows for the identification of neoantigens unique to each
patient's tumor to be included in a personalized cancer vaccine that targets these
neoantigens. This vaccine regimen uses two vaccine vectors as a heterologous prime/boost
approach (GRT-C901, ChAd as prime and GRT-R902, samRNA as boost) to stimulate an immune
response. This study (GRANITE-CRC-ADJUVANT) will explore the anti-tumor activity of this
individualized, patient specific immunotherapy in combination with checkpoint inhibitors.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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