What side effects are associated with this type of intervention?

Common side effects of treatments for colorectal cancer, particularly those involving patient-specific vaccines (like GRT-C901/GRT-R902) and checkpoint inhibitors, include inflammation-related issues such as colitis, pneumonitis, hepatitis, endocrinopathies, and skin reactions. Patient-specific vaccines may also cause localized reactions at the injection site and flu-like symptoms. Both treatment types can lead to immune system overactivation, resulting in autoimmune-like symptoms that require careful management.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of colorectal cancer, particularly those that target immune checkpoints. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are checkpoint inhibitors that target PD-1 and have been approved for use in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer. These drugs enhance the immune system's ability to fight cancer by blocking the PD-1 pathway, which tumors use to evade immune detection. While patient-specific vaccines like GRT-C901/GRT-R902 are still under investigation, these checkpoint inhibitors represent a significant advancement in the immunotherapy landscape for colorectal cancer.

What other types of research exist?

Promising novel alternatives for colorectal cancer treatment in 2024 include: 1) CAR-T cell therapy, which involves engineering a patient's T cells to target cancer cells; 2) Bispecific T-cell engagers (BiTEs), which are designed to direct T cells to cancer cells; 3) Oncolytic virus therapy, which uses genetically modified viruses to kill cancer cells and stimulate an immune response; 4) Novel targeted therapies such as KRAS inhibitors for patients with specific genetic mutations; and 5) Combination therapies that integrate immunotherapy with other modalities like radiation or chemotherapy to enhance treatment efficacy.

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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

Must not have

Known DNA Polymerase Epsilon mutations

Patients with known BRAFV600E mutations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up phase 2 up to 27 months, phase 3 up to 60 months

Awards & highlights

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 below

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I am fully active or can carry out light work.

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My cancer has spread, cannot be surgically removed, and can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has a DNA Polymerase Epsilon mutation.

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My cancer has a BRAFV600E mutation.

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I have brain metastases that are worsening or causing symptoms.

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I have a bleeding disorder or often bruise or bleed a lot after shots or blood tests.

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I have had a transplant of tissue or an organ from another person.

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My tumor has a low mutation rate.

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I haven't had a heart attack or serious heart issues in the last 3 months.

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I do not have active tuberculosis, significant recent infections, hepatitis B or C, or HIV.

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My cancer is identified as having mismatch repair deficiency or high microsatellite instability.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 2 up to 27 months, phase 3 up to 60 months for reporting.

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 more

Trial 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

~2610

Bevacizumab

2013

Completed Phase 4

~5280

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Patient-specific vaccines, such as GRT-C901/GRT-R902, work by eliciting an immune response specifically targeted against the tumor's unique antigens, thereby helping the immune system recognize and attack cancer cells. Checkpoint inhibitors, on the other hand, enhance the immune system's ability to fight cancer by blocking proteins that inhibit immune responses, such as PD-1 or CTLA-4, thus allowing T-cells to effectively target and destroy cancer cells. These treatments are crucial for colorectal cancer patients as they offer a personalized approach to therapy, potentially improving efficacy and reducing the likelihood of resistance compared to traditional treatments.

[Molecule based diagnosis].

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

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05141721 — Phase 2 & 3

Colorectal Cancer Research Study Groups: Vaccine Arm, Control Arm

Colorectal Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05141721 — Phase 2 & 3

Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05141721 — Phase 2 & 3

Colorectal Cancer Patient Testimony for trial: Trial Name: NCT05141721 — Phase 2 & 3

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