GRT-C901/GRT-R902 Vaccine arm for Cancer of Colon

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Barbara Ann Karmanos Cancer Institute, Detroit, MI
Cancer of Colon+2 More
Ipilimumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions

  • Cancer of Colon
  • Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: From time of randomization until death due to any cause (Up to ~36 months)

Month 24
Conversion of Patients with ctDNA at Baseline to Undetectable ctDNA as Assessed via a Polymerase Chain Reaction (PCR)-Based Assay
Longest Duration of Molecular response of ctDNA Decrease from Baseline
Percentage of Patients with a ≥50% Decrease from Baseline in Circulating Tumor deoxyribonucleic acid (ctDNA)
Month 36
Overall Survival (OS)
Month 36
Disease-free survival (DFS) per Investigator
Month 36
Recurrence-free survival (RFS) per Investigator
Day 28
Success of Vaccine Manufacture
Week 62
Incidence and Severity of Adverse Events
Up to ~24 months
T-cell response using Peripheral Blood Mononuclear Cells (PBMCs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Observation arm
1 of 2
GRT-C901/GRT-R902 Vaccine arm
1 of 2
Active Control
Experimental Treatment

142 Total Participants · 2 Treatment Groups

Primary Treatment: GRT-C901/GRT-R902 Vaccine arm · No Placebo Group · Phase 2

GRT-C901/GRT-R902 Vaccine armExperimental Group · 5 Interventions: Ipilimumab, GRT-R902, Adjuvant chemotherapy, Atezolizumab, GRT-C901 · Intervention Types: Drug, Drug, Drug, Drug, Drug
Observation arm
Drug
ActiveComparator Group · 1 Intervention: Adjuvant chemotherapy · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~3350
Adjuvant chemotherapy
2016
Completed Phase 2
~40
Atezolizumab
2015
Completed Phase 4
~6340

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from time of randomization until death due to any cause (up to ~36 months)
Closest Location: Barbara Ann Karmanos Cancer Institute · Detroit, MI
Photo of mi barbara ann karmanos cancer institute  1Photo of mi barbara ann karmanos cancer institute  2Photo of Detroit  3
2003First Recorded Clinical Trial
1 TrialsResearching Cancer of Colon
393 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a woman of childbearing potential (WCBP) and are 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.
You have a performance status of 0 to 1 or equivalent for patients 12-17 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.