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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.

Primary and/or metastatic tumor(s) that is known to be MSS as determined locally

Must not have

Significant liver cirrhosis defined as Child-Pugh Class B or C

Has had major surgical procedure, open biopsy or significant traumatic injury within 28 days of the first dose of study therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study entry up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am fully active or can carry out light work.

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My cancer is not microsatellite instability-high (MSI-H).

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I am fully active or restricted in physically strenuous activity but can do light work.

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My colorectal cancer has spread and this was confirmed by a lab test.

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I am 18 years old or older.

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I am 18 years or older and can sign the consent form.

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My cancer has worsened after my last treatment.

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My colorectal cancer has spread and is confirmed by lab tests.

Exclusion Criteria

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

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My liver condition is severe.

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I have not had major surgery or significant injury within the last 28 days.

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I have not received a live vaccine in the last 28 days.

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I have lung problems that could affect new lung side effects from treatment.

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My cancer has spread to my brain or spinal cord.

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I haven't had cancer treatment within the last 28 days or 5 half-lives of the drug, whichever is shorter.

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I am currently on medication for an infection.

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I have previously been treated with immune checkpoint inhibitors.

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I have had a bone marrow or organ transplant in the past.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study entry up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Administration safety

The incidence and severity treatment related Adverse Events

Secondary study objectives

Duration of Response assessment

Measured Effector T Cell Immune Response

Measured Memory T Cell Immune Response

+4 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

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%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2016

Completed Phase 3

~5860

0 / 17Eligibility criteria met