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Checkpoint Inhibitor
PolyPEPI1018 + Atezolizumab for Colorectal Cancer
Phase 2
Waitlist Available
Led By Joleen Hubbard, MD
Research Sponsored by Treos Bio Limited
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 to 1.
Willingness to undergo biopsy prior to study therapy and after approximately 6 weeks of study therapy. If biopsy on study is not feasible, then archival tissue must be available from within 90 days of signing consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study entry up to 3 years
Awards & highlights
Study Summary
This trial is testing a new combination cancer treatment to see if it is safe and effective.
Who is the study for?
Adults over 18 with metastatic colorectal cancer (MSS CRC) who have tried and progressed on 2-3 prior treatments can join this trial. They must be in good physical condition, not pregnant or breastfeeding, willing to undergo biopsies and provide consent. Excluded are those with autoimmune diseases, recent vaccines or surgeries, active infections like HIV/HBV/HCV, CNS metastases, history of severe allergies to vaccines or proteins.Check my eligibility
What is being tested?
The trial is testing the combination of a new vaccine called PolyPEPI1018 with an existing cancer drug Atezolizumab in patients whose colorectal cancer has worsened after previous treatments. It's an open-label phase II study focusing on safety and how well the body responds to this combo.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site from the vaccine and typical immune therapy-related issues such as fatigue, diarrhea, skin rash from Atezolizumab. There may also be risks associated with organ inflammation due to immune response.
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.
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I agree to have a biopsy before and 6 weeks after starting the study therapy, or I have tissue samples available from the last 3 months.
Select...
My cancer is not microsatellite instability-high (MSI-H).
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer can be measured by scans and has grown after radiation.
Select...
My colorectal cancer has spread and this was confirmed by a lab test.
Select...
I am 18 years old or older.
Select...
I am 18 years or older and can sign the consent form.
Select...
My cancer has worsened after my last treatment.
Select...
My colorectal cancer has spread and is confirmed by lab tests.
Select...
I am willing to have a cheek swab test for the study.
Select...
I've had 2-3 treatments for advanced colorectal cancer, including specific drugs and possibly some biologics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study entry up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study entry up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Administration safety
The incidence and severity treatment related Adverse Events
Secondary outcome measures
Duration of Response assessment
Measured Effector T Cell Immune Response
Measured Memory T Cell Immune Response
+4 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: PolyPEPI1018 plus AtezolizumabExperimental Treatment2 Interventions
Participants receive every 3 weeks PolyPEPI1018 CRC Vaccine (Emulsified solution, 0.2 mg/peptide, 6 peptides total, and Montanide™ ISA51VG adjuvant), by SC injection in combination with Atezolizumab (Injectable solution,1200mg/20mL) by IV injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Mayo ClinicOTHER
3,206 Previous Clinical Trials
3,767,065 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,428 Previous Clinical Trials
1,089,036 Total Patients Enrolled
Treos Bio LimitedLead Sponsor
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: PolyPEPI1018 plus Atezolizumab
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many medical facilities are currently conducting this investigation?
"This study is currently being conducted in 4 different cities: Rochester, Jacksonville, Phoenix and multiple other locations. Choosing to enrol at the closest medical centre will help ease any travel requirements associated with participation."
Answered by AI
What has been the track record of safety for PolyPEPI1018 users?
"Our assessment of PolyPEPI1018's safety was scored a 2 because this is only a Phase 2 trial, thus there exists some evidence for its security but not much demonstrating efficacy."
Answered by AI
How many participants are enrolled in the research program?
"Affirmative. According to the information on clinicaltrials.gov, this medical study is open for recruitment and was initially published on June 2nd 2022. This research requires 28 participants from 4 different sites and was last updated on September 30th 2022."
Answered by AI
What results is this trial hoping to uncover?
"Per the sponsor of this trial, Treos Bio Limited, Administration safety will serve as the principal metric for evaluation over a 90-day period. Additionally, Overall Survival (OS), Objective Response Rate (ORR), and Progression Free Survival (PFS) shall be monitored to determine efficacy in terms of radiographic imaging per RECIST 1.1 criteria."
Answered by AI
Are there any openings available for those wishing to take part in the trial?
"The information on clinicaltrials.gov indicates that this experiment is actively recruiting patients, which was first published on June 2nd 2022 and most recently updated September 30th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Met criteria
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