A Vaccine (PolyPEPI1018 Vaccine) and TAS-102 for the Treatment of Metastatic Colorectal Cancer

NCT05130060 | Completed Phase 1 DMC FDA Drug

• 4 other identifiers: MC200404NCI-2021-11619CA19083620-013410
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metastatic Colon Adenocarcinoma; Metastatic Colorectal Adenocarcinoma; Metastatic Colorectal Carcinoma; Metastatic Microsatellite Stable Colon Carcinoma; Metastatic Microsatellite Stable Colorectal Carcinoma; Metastatic Rectal Adenocarcinoma; Microsatellite Stable Rectal Carcinoma; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 year

Secondary Outcomes (4)

• Overall response rate (ORR)

  Up to 1 year

• Duration of response (DoR)

  Up to 1 year

• Overall survival (OS)

  From registration to death from any cause, assessed up to 1 year

• Progression free survival (PFS)

  From registration to progression or death from any cause, whichever happens first, assessed up to 1 year

Study Arms (1)

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.

Biological: Colorectal Cancer Peptide Vaccine PolyPEPI1018; Drug: Trifluridine and Tipiracil Hydrochloride

Interventions

Colorectal Cancer Peptide Vaccine PolyPEPI1018 BIOLOGICAL

Given SC

Also known as: PolyPEPI 1018, PolyPEPI-1018, PolyPEPI1018, PolyPEPI1018 CRC Peptide Vaccine, PolyPEPI1018 CRC Vaccine

Treatment (PolyPEPI1018, TAS-102)

Trifluridine and Tipiracil Hydrochloride DRUG

Given PO

Also known as: Lonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with Trifluridine, Trifluridine/Tipiracil, Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102

Treatment (PolyPEPI1018, TAS-102)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms; Rectal Neoplasms

Interventions

Trifluridine; trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mojun Zhu, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: January 10, 2022
• Primary Completion: June 11, 2023
• Study Completion: June 11, 2023
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

US (1)