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Checkpoint Inhibitor
Neoantigen Vaccine + Immune Checkpoint Blockade for Colorectal Cancer
Phase 2 & 3
Waitlist Available
Research Sponsored by Gritstone Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Measurable and unresectable metastatic disease according to RECIST v1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 2 up to 27 months, phase 3 up to 60 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment regime that includes two new drugs alongside existing ones, to see if it is more effective than the existing treatment. The primary objective is to see if the new regime extends progression-free survival.
Who is the study for?
This trial is for adults with metastatic colorectal cancer who've started or are about to start first-line treatment. They must have measurable disease, provide tumor samples, be in good physical condition (ECOG 0-1), and have proper organ function. Women able to bear children must agree to contraception during the study and afterwards.Check my eligibility
What is being tested?
The trial tests a personalized vaccine (GRT-C901/GRT-R902) with immune checkpoint inhibitors against standard chemotherapy with bevacizumab. It aims to see if the vaccine combo can improve survival without cancer progression by monitoring changes in ctDNA levels.See study design
What are the potential side effects?
Potential side effects include typical reactions from immunotherapy like fatigue, skin reactions, inflammation of organs; chemotherapy-related nausea, hair loss; and specific risks such as bleeding due to bevacizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My cancer has spread, cannot be surgically removed, and can be measured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ phase 2 up to 27 months, phase 3 up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase 2 up to 27 months, phase 3 up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 2: Molecular response defined as ≥ 30% decrease from baseline in circulating tumor DNA (ctDNA)
Phase 3: Progression-free survival per Immune-based Response Evaluation Criteria in Solid Tumors (iRECIST) as assessed by blinded independent review committee (IRC)
Secondary outcome measures
Phase 2 and 3: Clinical benefit rate (CBR) as defined by the proportion of patients with best overall response of stable disease (SD), PR or CR using RECIS v1.1 or immune-based SD (iSD), iPR, or iCR by iRECIST.
Phase 2 and 3: Deepening of Response the proportion of patients who have a BOR of SD or PR during the VPS and who convert from SD to PR or CR, or from PR to CR after start of the study treatment and/or SOC maintenance treatment in the STS per RECIST v1.1
Phase 2 and 3: Duration of response (DOR) defined by time from the first objective response of PR or PR until disease progression or death
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Vaccine ArmExperimental Treatment6 Interventions
After receiving up to 24 weeks induction therapy with a fluoropyrimidine/oxaliplatin/bevacizumab (with or without irinotecan), per standard of care and after completing vaccine production screening, patients will receive a total of 6 administrations of GRT-C901/GRT-R902 plus ipilimumab co-administered only with the first dose of GRT-C901 and GRT-R902. All patients will receive atezolizumab in addition to maintenance therapy of a fluoropyrimidine and bevacizumab according to standard of care.
Group II: Control ArmActive Control2 Interventions
After receiving up to 24 weeks induction therapy with a fluoropyrimidine/oxaliplatin/bevacizumab (with or without irinotecan), per standard of care and undergoing vaccine production screening, patients will receive maintenance therapy of a fluoropyrimidine and bevacizumab according to standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GRT-C901
2019
Completed Phase 2
~30
GRT-R902
2019
Completed Phase 2
~30
Atezolizumab
2017
Completed Phase 3
~5860
Ipilimumab
2014
Completed Phase 3
~2620
Bevacizumab
2013
Completed Phase 4
~5280
Who is running the clinical trial?
Gritstone Bio, Inc.Lead Sponsor
5 Previous Clinical Trials
223 Total Patients Enrolled
Gritstone Oncology, Inc.Lead Sponsor
5 Previous Clinical Trials
223 Total Patients Enrolled
Gritstone bio, Inc.Lead Sponsor
8 Previous Clinical Trials
647 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor has a low mutation rate.My cancer has a DNA Polymerase Epsilon mutation.My cancer has a BRAFV600E mutation.I have had pneumonitis treated with steroids, except for lung inflammation from radiation that's resolved.I have a bleeding disorder or often bruise or bleed a lot after shots or blood tests.I have had a transplant of tissue or an organ from another person.I am fully active or can carry out light work.I haven't had any other cancer in the past 2 years, except for one that was treated with the intent to cure.I have metastatic colorectal cancer and am starting or have just started first-line treatment.My cancer has spread, cannot be surgically removed, and can be measured.My organs are functioning well.I do not have active tuberculosis, significant recent infections, hepatitis B or C, or HIV.I have brain metastases that are worsening or causing symptoms.I haven't had a heart attack or serious heart issues in the last 3 months.My cancer is identified as having mismatch repair deficiency or high microsatellite instability.
Research Study Groups:
This trial has the following groups:- Group 1: Vaccine Arm
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT05141721 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any other ongoing or previous clinical trials involving GRT-C901?
"There are 1254 ongoing clinical trials investigating GRT-C901. Of these, 293 have reached Phase 3 status. Many of the trials related to GRT-C901 are located in Guangzhou, Guangdong; however, there are 63018 total research sites running similar experiments."
Answered by AI
To what purpose is GRT-C901 most often employed?
"GRT-C901 has shown efficacy in treating cancers that have progressed after treatment with fluoropyrimidine, oxaliplatin and irinotecan. Additionally, it can also ameliorate metastatic ureter urothelial carcinoma, malignant neoplasms, and persistent cervical cancer."
Answered by AI
Are we still enrolling patients for this experiment?
"The trial is recruiting patients, with the most recent update to the clinicaltrials.gov listing being on 10/27/2022. It was initially posted on 2/12/2022."
Answered by AI
From how many different sites is this experiment being coordinated?
"Presently, this study is recruiting patients from 51 medical facilities. These include Prisma Health in Greenville, South carolina; Sansum Clinic - USOR in Santa Barbara, California; Allegheny General Hospital in Pittsburgh, Pennsylvania; and 48 other locations."
Answered by AI
How many people are being enrolled in this trial?
"In order to carry out this clinical trial, 665 individuals that meet the pre-determined inclusion criteria must agree to participate. These potential participants are sourced from different locations, two of which being Prisma Health in Greenville, South carolina and Sansum Clinic - USOR in Santa Barbara, California."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
interested in ridding myself of cancer.
PatientReceived 1 prior treatment
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