Metastatic Colon AdenocarcinomaPhase 1NCT05130060
A Vaccine (PolyPEPI1018 Vaccine) and TAS-102 for the Treatment of Metastatic Colorectal Cancer
A Phase 1 study testing Colorectal Cancer Peptide Vaccine PolyPEPI1018 and Trifluridine and Tipiracil Hydrochloride in people with Metastatic Colon Adenocarcinoma and Metastatic Colorectal Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase Ib trial studies the safety and side effects of a vaccine (PolyPEPI1018 vaccine) in combination with TAS-102 in treating patients with colorectal that has spread to other parts of the body (metastatic). PolyPEPI1018 peptide vaccine is used to immunize against proteins present on the surface of tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colon Adenocarcinoma, Metastatic Colorectal Adenocarcinoma, Metastatic Colorectal Carcinoma
- What is being tested?
- Colorectal Cancer Peptide Vaccine PolyPEPI1018 and Trifluridine and Tipiracil Hydrochloride
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 11 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Histologically confirmed metastatic adenocarcinoma originating from the colon or the rectum, microsatellite stable
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible
- Received =< 2 lines of prior chemotherapy regimen for mCRC
- NOTE: Adjuvant therapy will not be considered a line of therapy for mCRC unless the patient had disease recurrence =< 6 months of adjuvant therapy
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- Provide written informed consent
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 21 days prior to registration)
- Platelet count >= 100,000/mm^3 (obtained =< 21 days prior to registration)
- Hemoglobin >= 9 g/dL (obtained =< 21 days prior to registration)
- Total bilirubin =< 1.5 x ULN (obtained =< 21 days prior to registration)
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 3 x ULN (=< 5 x ULN for patients with liver involvement) (obtained =< 21 days prior to registration)
- Calculated creatinine clearance >= 30 ml/min using the Cockcroft-Gault formula (obtained =< 21 days prior to registration)
- Anticipated life expectancy >= 6 months
- Negative urine pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
- NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Women of childbearing potential must agree to appropriately use an effective form of contraception (failure rate of < 1% per year) while enrolled in the study and for 3 months from the last vaccination. An effective form of contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, cervical cap or condom
- Men must agree to use an effective form of contraception (as defined above), and not donate sperm for 3 months from the last vaccination
- Willingness to provide mandatory blood and buccal swab specimens for correlative research
- Willingness to provide mandatory tissue specimens for correlative research
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study). Note: During the active monitoring phase of a study
Who cannot join
- Received continuous systemic steroid treatment =< 2 weeks prior to registration
- Colorectal cancer with documented high microsatellite instability (MSI H)
- Pre-existing systemic autoimmune or antibody-mediated diseases or immune deficiency diseases
- Central nervous system (CNS) metastases
- Serious, non-healing wounds, ulcers or bone fractures
- Nephrotic syndrome
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- Arterial thromboembolisms or severe hemorrhages =< 6 months before registration (except bleeding tumor before tumor resection surgery)
- Any of the following prior therapies:
- Major surgery =< 12 weeks prior to registration or anticipation of needing such procedure during the study period
- Radiation therapy =< 4 weeks prior to registration
- Received chronic systemic immune therapy or immunosuppressant medication other than steroids =< 6 weeks prior to registration
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage > once every 28 days
- Participants with active malignancy (other than colorectal cancer [CRC]) or a prior malignancy =< 12 months prior to registration
- EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
- Acute or subacute intestinal obstruction or history of chronic intestinal inflammatory diseases
- Relevant toxicities of prior therapies must have resolved to =< grade 1, except for oxaliplatin-related neuropathy or alopecia
- Participant with myocardial infarction =< 6 months prior to registration or New York Heart Association Class III or IV, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Administration of a live, attenuated vaccine =< 4 weeks prior to registration or anticipation of a live attenuated vaccine will be required during the study
- Participant has or will be participating in any of the following:
- In another clinical study involving an investigational product (IP) or investigational device =< 30 days prior to registration or
- Is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study or
- Is receiving any other investigational agent which would be considered as a treatment for colorectal cancer
- Known hypersensitivity to any component of the investigational drug
- Uncontrolled intercurrent non-cardiac illness including, but not limited to:
- Ongoing or active infection
- Psychiatric illness/social situations
- Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
- Any other conditions that would limit compliance with study requirements
- Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant persons
- Nursing persons
- Men and women of childbearing potential who are unwilling to employ adequate contraception
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Phase Ib Open-Label Study to Evaluate Safety, Tolerability, Immunogenicity and Efficacy of Multiple Subcutaneous Injections of PolyPEPI1018 Vaccine as an Add-on Immunotherapy to TAS-102 in Late-Stage Metastatic Colorectal Cancer Subjects
This phase Ib trial studies the safety and side effects of a vaccine (PolyPEPI1018 vaccine) in combination with TAS-102 in treating patients with colorectal that has spread to other parts of the body (metastatic). PolyPEPI1018 peptide vaccine is used to immunize against proteins present on the surface of tumor cells. This vaccine can activate the body's immune cells, called T cells. T cells fight infections and can also kill cancer cells. TAS-102 may help block the formation of growths that may become cancer. Giving PolyPEPI1018 and TAS-102 may kill more tumor cells in patients with metastatic colorectal cancer.
Read the detailed description
PRIMARY OBJECTIVE I. To evaluate the safety and tolerability of multiple doses of colorectal cancer peptide vaccine PolyPEPI1018 (PolyPEPI1018) with trifluridine and tipiracil hydrochloride (TAS-102) in patients with metastatic colorectal cancer (mCRC).
SECONDARY OBJECTIVES:
- To evaluate initial efficacy of PolyPEPI1018 with TAS-102 by evaluating progression free survival (PFS).
II. To evaluate initial efficacy of PolyPEPI1018 with TAS-102 by evaluating objective response rate (ORR).
III. To evaluate initial efficacy of PolyPEPI1018 with TAS-102 by evaluating duration of response (DoR).
IV. To evaluate initial efficacy of PolyPEPI1018 with TAS-102 by evaluating overall survival (OS).
CORRELATIVE OBJECTIVES:
- Comparison of clinical benefit characteristics (ORR, PFS, OS or DoR) of the study with historical data of TAS-102.
II. Correlations between personal epitopes (PEPIs) identified by candidate CDx and T cell responses measured by enzyme-linked immune absorbent spot (ELISPOT).
III. To evaluate correlation between immune correlatives (T-cell responses in the blood and tumor and clinical benefit [ORR, PFS, OS or DoR]).
IV. To evaluate correlation between PEPIs/AGPs predicted by candidate CDx and clinical benefit (ORR, PFS, OS or DoR).
- To evaluate the immunogenicity of PolyPEPI1018 by measuring both effector and memory T cell responses, VI. To evaluate immune activity of PolyPEPI1018 at tumor level (level of tumor infiltrating lymphocytes).
VII. To identify PEPIs (Personal EPItopes capable of inducing T cell responses in an individual) and AGPs (predicted number of expressed antigens likely hit by T cells) from PolyPEPI1018 in each patient.
OUTLINE:
Patients receive PolyPEPI1018 subcutaneously (SC) at 4 injection sites on days 1 and 15 and trifluridine and tipiracil hydrochloride orally (PO) twice daily (BID) on days 1-5 and 8-15. Treatment repeats every 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 1 year.
- Conditions
- Metastatic Colon Adenocarcinoma, Metastatic Colorectal Adenocarcinoma, Metastatic Colorectal Carcinoma, Metastatic Microsatellite Stable Colon Carcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Metastatic Rectal Adenocarcinoma
- Being tested
- Colorectal Cancer Peptide Vaccine PolyPEPI1018, Trifluridine and Tipiracil Hydrochloride
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal Cancer Peptide Vaccine PolyPEPI1018Biological
Also called PolyPEPI 1018, PolyPEPI-1018, PolyPEPI1018, PolyPEPI1018 CRC Peptide Vaccine
Given SC
Trifluridine and Tipiracil HydrochlorideDrug
Also called Lonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with Trifluridine
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (PolyPEPI1018, TAS-102) | Experimental | Patients receive PolyPEPI1018 SC at 4 injection sites on days 1 and 15 and trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-15. Treatment repeats every 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity. Receives: Biological: Colorectal Cancer Peptide Vaccine PolyPEPI1018; Drug: Trifluridine and Tipiracil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AE)
The occurrence of at least 1 Grade 4 local AE or 1 Grade 3+ systemic AE during the first cycle of treatment. Evaluable patients are patients who are eligible, consented, received at least 50% of their expected cycle 1 trifluridine and tipiracil hydrochloride treatment, and received at least one dose of the PolyPEPI1018 Vaccine. The final local or systemic AE rate point estimate and corresponding 95% confidence interval will be reported.
Measured: Up to 1 year
Secondary outcomes (4)
Overall response rate (ORR)
ORR is defined as achieving complete response (CR) or partial response (PR) while on treatment. Disease status will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. ORR will be calculated as the proportion of evaluable patients who achieve response. The final ORR point estimate and corresponding 95% confidence interval will be reported.
Measured: Up to 1 year
Duration of response (DoR)
DoR is defined at the time from first documented response (PR or CR) via RECIST 1.1 to progression or death. DoR will be estimated using the Kaplan-Meier method. Patients who are alive and progression-free will be censored at the last follow-up date. The median DoR and corresponding 95% confidence interval will be reported.
Measured: Up to 1 year
Overall survival (OS)
OS will be estimated using the Kaplan-Meier method. Patients who are alive will be censored at the last follow-up date. The median OS and corresponding 95% confidence interval will be reported.
Measured: From registration to death from any cause, assessed up to 1 year
Progression free survival (PFS)
Disease status will be assessed using RECIST 1.1 criteria. PFS will be estimated using the Kaplan-Meier method. Patients who are alive and progression-free will be censored at their last disease assessment date. The median PFS and corresponding 95% confidence interval will be reported.
Measured: From registration to progression or death from any cause, whichever happens first, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start10 Jan 2022
- Primary completion11 Jun 2023
- Study completion11 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colon AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mojun Zhu, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130060
- Sponsor's protocol ID
- MC200404
- Other IDs
- NCI-2021-11619, W81XWH-20-1-0810, 20-013410
- Status last verified
- Aug 2024
- First submitted
- 10 Nov 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Open-Label Study to Evaluate Safety, Tolerability, Immunogenicity and Efficacy of Multiple Subcutaneous Injections of PolyPEPI1018 Vaccine as an Add-on Immunotherapy to TAS-102 in Late-Stage Metastatic Colorectal Cancer Subjects
- ClinicalTrials.gov ID
- NCT05130060
- Acronym / sponsor ID
- MC200404
- Conditions
- Metastatic Colon Adenocarcinoma, Metastatic Colorectal Adenocarcinoma, Metastatic Colorectal Carcinoma, Metastatic Microsatellite Stable Colon Carcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Metastatic Rectal Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 11 Jun 2023 (actual)
- Study completion
- 11 Jun 2023 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase Ib trial studies the safety and side effects of a vaccine (PolyPEPI1018 vaccine) in combination with TAS-102 in treating patients with colorectal that has spread to other parts of the body (metastatic). PolyPEPI1018 peptide vaccine is used to immunize against proteins present on the surface of tumor cells. This vaccine can activate the body's immune cells, called T cells. T cells fight infections and can also kill cancer cells. TAS-102 may help block the formation of growths that may become cancer. Giving PolyPEPI1018 and TAS-102 may kill more tumor cells in patients with metastatic colorectal cancer.
Detailed description
PRIMARY OBJECTIVE I. To evaluate the safety and tolerability of multiple doses of colorectal cancer peptide vaccine PolyPEPI1018 (PolyPEPI1018) with trifluridine and tipiracil hydrochloride (TAS-102) in patients with metastatic colorectal cancer (mCRC).
SECONDARY OBJECTIVES:
- To evaluate initial efficacy of PolyPEPI1018 with TAS-102 by evaluating progression free survival (PFS).
II. To evaluate initial efficacy of PolyPEPI1018 with TAS-102 by evaluating objective response rate (ORR).
III. To evaluate initial efficacy of PolyPEPI1018 with TAS-102 by evaluating duration of response (DoR).
IV. To evaluate initial efficacy of PolyPEPI1018 with TAS-102 by evaluating overall survival (OS).
CORRELATIVE OBJECTIVES:
- Comparison of clinical benefit characteristics (ORR, PFS, OS or DoR) of the study with historical data of TAS-102.
II. Correlations between personal epitopes (PEPIs) identified by candidate CDx and T cell responses measured by enzyme-linked immune absorbent spot (ELISPOT).
III. To evaluate correlation between immune correlatives (T-cell responses in the blood and tumor and clinical benefit [ORR, PFS, OS or DoR]).
IV. To evaluate correlation between PEPIs/AGPs predicted by candidate CDx and clinical benefit (ORR, PFS, OS or DoR).
- To evaluate the immunogenicity of PolyPEPI1018 by measuring both effector and memory T cell responses, VI. To evaluate immune activity of PolyPEPI1018 at tumor level (level of tumor infiltrating lymphocytes).
VII. To identify PEPIs (Personal EPItopes capable of inducing T cell responses in an individual) and AGPs (predicted number of expressed antigens likely hit by T cells) from PolyPEPI1018 in each patient.
OUTLINE:
Patients receive PolyPEPI1018 subcutaneously (SC) at 4 injection sites on days 1 and 15 and trifluridine and tipiracil hydrochloride orally (PO) twice daily (BID) on days 1-5 and 8-15. Treatment repeats every 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (PolyPEPI1018, TAS-102) | Experimental | Biological: Colorectal Cancer Peptide Vaccine PolyPEPI1018, Drug: Trifluridine and Tipiracil HydrochloridePatients receive PolyPEPI1018 SC at 4 injection sites on days 1 and 15 and trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-15. Treatment repeats every 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age >= 18 years
- Histologically confirmed metastatic adenocarcinoma originating from the colon or the rectum, microsatellite stable
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Received =< 2 lines of prior chemotherapy regimen for mCRC
- Provide written informed consent
Key exclusion criteria (32 listed)
- Received continuous systemic steroid treatment =< 2 weeks prior to registration
- Colorectal cancer with documented high microsatellite instability (MSI H)
- Pre-existing systemic autoimmune or antibody-mediated diseases or immune deficiency diseases
- Central nervous system (CNS) metastases
- Serious, non-healing wounds, ulcers or bone fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal Cancer Peptide Vaccine PolyPEPI1018Also: PolyPEPI 1018, PolyPEPI-1018, PolyPEPI1018, PolyPEPI1018 CRC Peptide VaccineGiven SC | Biological | Treatment (PolyPEPI1018, TAS-102) |
| Trifluridine and Tipiracil HydrochlorideAlso: Lonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with TrifluridineGiven PO | Drug | Treatment (PolyPEPI1018, TAS-102) |
Primary outcome
Incidence of adverse events (AE)
Time frame: Up to 1 year
The occurrence of at least 1 Grade 4 local AE or 1 Grade 3+ systemic AE during the first cycle of treatment. Evaluable patients are patients who are eligible, consented, received at least 50% of their expected cycle 1 trifluridine and tipiracil hydrochloride treatment, and received at least one dose of the PolyPEPI1018 Vaccine. The final local or systemic AE rate point estimate and corresponding 95% confidence interval will be reported.
4 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 1 year
Duration of response (DoR)
Time frame: Up to 1 year
Overall survival (OS)
Time frame: From registration to death from any cause, assessed up to 1 year
Progression free survival (PFS)
Time frame: From registration to progression or death from any cause, whichever happens first, assessed up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mojun Zhu, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Colorectal Cancer Peptide Vaccine PolyPEPI1018 and Trifluridine and Tipiracil Hydrochloride in people with Metastatic Colon Adenocarcinoma and Metastatic Colorectal Adenocarcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AE) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.