A Study of a Personalized Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the Phase 2 portion of the study is to characterize the clinical activity of maintenance therapy with GRT-C901/GRT-R902 in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone as assessed by changes in circulating tumor (ct)DNA. The primary objective of the Phase 3 portion is to demonstrate clinical efficacy of the regime as assessed by progression-free survival.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gritstone Oncology, Inc.
• Treatments: Atezolizumab; Bevacizumab; Ipilimumab; Oxaliplatin

Criteria

Inclusion Criteria:

• Patients with histologically confirmed metastatic colorectal cancer (CRC) who are planned for, or have received no more than 1 cycle of first-line treatment in the metastatic setting with a fluoropyrimidine and oxaliplatin in combination with bevacizumab

• Measurable and unresectable disease according to RECIST v1.1

• Availability of formalin-fixed paraffin-embedded (FFPE) tumor specimens.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or equivalent for patients 12 to 17 years of age

• Patient has adequate organ function in opinion of investigator

• If women of childbearing potential (WCBP), must be willing to undergo pregnancy testing and agrees to the use at least 1 highly effective contraceptive method during the study treatment period and for 5 months after last investigational study treatment.

Exclusion Criteria:

• Patients with microsatellite instability-high disease

• Patient has a known tumor mutation burden <1 non-synonymous mutations/megabase

• Known DNA Polymerase Epsilon mutations

• Patients with known BRAFV600E mutations

• Bleeding disorder or history of significant bruising or bleeding following IM injections or blood draws

• Immunosuppression anticipated at time of study treatment

• History of allogeneic tissue/solid organ transplant

• Active or history of autoimmune disease or immune deficiency

• Patient with symptomatic or actively progressing central nervous system (CNS) metastases, carcinomatous meningitis, or has been treated with whole brain radiation

• History of other cancer within 2 years with the exception of neoplasm that has undergone potentially curative therapy

• Any severe concurrent non-cancer disease that, in the judgment of the Investigator, would make the patient inappropriate for the current study

• Active tuberculosis or recent (<2 weeks) clinically significant infection, evidence of active hepatitis B or hepatitis C, or known history of positive test for HIV

• History of pneumonitis requiring systemic steroids for treatment (with the exception of prior resolved in-field radiation pneumonitis)

• Myocardial infarction within previous 3 months or prior to study treatment, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure

• Pregnant, planning to become pregnant, or nursing.