Safety and Activity of PolyPEPI1018 Plus Atezolizumab in Colorectal Cancer. (NCT05243862) | Clinical Trial Compass
CompletedPhase 2
Safety and Activity of PolyPEPI1018 Plus Atezolizumab in Colorectal Cancer.
United States18 participantsStarted 2022-06-02
Plain-language summary
This is a multicenter, open label, phase II trial to determine the safety, tolerability, and immunogenicity and initial clinical activity of the combination treatment of PolyPEPI1018 vaccine and atezolizumab in participants with MSS CRC who have progressed on 2 or 3 prior regimens.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide written informed consent for the trial.
. Adults 18 years or older on the day of signing informed consent.
. Histologically or cytologically confirmed CRC that is metastatic.
. Primary and/or metastatic tumor(s) that is known to be MSS as determined locally
. Must have had 2-3 prior lines of therapy for CRC in the advanced or metastatic setting, including all of the following in the absence of contraindications: a) fluoropyrimidine, b) oxaliplatin, c) irinotecan, d) one or more biologics depending on the clinical scenario. Prior regorafenib and/or TAS-102 are allowed but not required. Note: a line of therapy is generally considered \>2 weeks of exposure to the same regimen followed by radiographically documented progression. Agents that are mechanistically similar (e.g. 5-fluorouracil and capecitabine) and are used interchangeably due to tolerability but not progression may be considered as components of the same regimen upon discussion with the medical monitor.
. 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.
. Willingness to undergo buccal swab prior to study therapy for the determination of HLA profile.
. Documented radiographic progression after the last regimen prior to entry on this study.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Incidence and Severity Treatment Related Adverse Events
Timeframe: From 1st dose until 90-Days after last dose, up to 7.5 months.
2
Clinical Laboratory Safety
Timeframe: From baseline to end of study, up to 12 months.
3
Administration Safety
Timeframe: From the start of each vaccine administration through 60 minutes after completion of each administration.
. Prior treatment with an anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other checkpoint inhibitors.
. Has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 28 days of the first dose of study therapy or 5 half-lives (whichever is shorter) if at least 10 days have elapsed between the last dose of such agents and the first dose of study therapy. NOTE: Patients who have been given palliative radiotherapy to peripheral sites (e.g., bone metastases) may enroll before 28 days have elapsed if they have recovered from any acute toxicities.
. Has received a live vaccine within 28 days of the first dose of study therapy.
. Has had major surgical procedure, open biopsy or significant traumatic injury within 28 days of the first dose of study therapy.
. Participating in another research study involving receipt of an investigational product 21 days prior to study therapy.
. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Note: Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study. Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen are also eligible for this study.
. Receiving systemic corticosteroids within one week prior to the first dose of study therapy. Exceptions: corticosteroid use as a premedication for intravenous (IV) contrast, intermittent corticosteroid use (e.g., daily prednisone at doses of ≤10 mg or equivalent), bronchodilators, inhaled steroids, or local steroid injections (except at the proposed injection site of PolyPEPI1018) are acceptable.
. History of anaphylaxis in relation to vaccination or the administration of a protein product.