A Study of a Personalized Neoantigen Cancer Vaccine

Overview

About this study

The purpose of this study is to evaluate the safety, dose, immunogenicity and early clinical activity of GRT-C901 and GRT-R902, a personalized neoantigen cancer vaccine, in combination with nivolumab and ipilimumab, in patients with metastatic non-small cell lung cancer, microsatellite stable colorectal cancer, gastroesophageal adenocarcinoma, and metastatic urothelial cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Provide a signed and dated informed consent form prior to initiation of study-specific procedures. 
  • Patients with the indicated advanced or metastatic solid tumor as follows:
    • NSCLC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy;
    • GEA who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy; 
    • mUC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy; 
    • CRC-MSS who are receiving first line systemic therapy or who are planned for or have received no more than 1 cycle of second line systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan.
  • 18 years of age or older.
  • ECOG Performance Status 0 or 1.
  • Lesion amenable to biopsy .
  • Measurable disease according to RECIST v1.1. 
  • Have adequate organ function, as measured by laboratory values (criteria listed in protocol).

Exclusion Criteria:

  • Tumors with genetic characteristics as follows:
    • For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK;
    • For CRC and GEA, patients with MSI disease;
    • For CRC, patients with a known BRAF V600E mutation or patients with peritoneal carcinomatosis.
  • Patients with known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to a vaccination.
  • Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significant bruising or bleeding following IM injections or blood draws Complete inclusion and exclusion criteria are listed in the clinical study protocol.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Daniel Ahn, D.O.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Kabir Mody, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Amit Mahipal, M.B.B.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions