RECRUITING

Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

Conditions

Ductal Carcinoma in Situ T cells cancer vaccine immune checkpoint lyse tumor cells

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Post-menopausal women with biopsy-proven DCIS will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor alone for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor and MUC1 vaccination (MUC1 peptide + Hiltonol®) pre-operatively at baseline, and weeks 2 and 10, followed by surgery at about 12 weeks. Patients in the vaccine cohort will be offered an optional boost vaccine 6 months after surgery.

Official Title

A Clinical Study of a Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

Quick Facts

Study Start:2024-02-07

Study Completion:2028-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06218303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Postmenopausal female, 18 years of age or older (no menstrual period for at least 12 months, or S/P oophorectomy) 2. Capable of providing informed consent and willing to comply with study procedures 3. Biopsy-proven ER+ DCIS * The signed pathology report from the attending pathologist will be used to determine eligibility. * At least one tissue core with DCIS must be available for research. * Patients with DCIS suspicious for microinvasion on core biopsy will be eligible because many of these patients will not have invasion on final pathology. * Women presenting with concurrent bilateral DCIS are eligible only if both the right and left DCIS lesions are ER+, and tissue from both sides will be analyzed and must meet the criteria below 4. DCIS must be \>=1cm based on the extent of calcifications on imaging, the presence of a mass on ultrasound or enhancement on MRI OR DCIS \>=5mm on one single core by pathologic evaluation OR DCIS \< 5mm if identified in \>=2 cores 5. Candidate for aromatase inhibitor 6. Surgery planned as part of definitive local therapy 7. ECOG PS 0-1 8. Absolute neutrophil count \>= 1.5 x 109/L 9. Platelet count \>= 100 x 109/L 10. Hemoglobin \>=9 g/dl or \>= 5.6 mmol/L 11. Creatinine \<=1.5X the upper limit of normal OR creatinine clearance \>=60 ml/min 12. Total bilirubin \<=1.5X the ULN; \<=2x ULN for patients with Gilbert's disease 13. AST and ALT \<= 2.5X ULN 14. INR/PT/aPTT \<=1.5X ULN or within the therapeutic range if on anti-coagulation	1. Invasive breast cancer \> 1mm on pathologic evaluation 2. Second malignancy within the last 5 years (definitively treated superficial non-melanoma skin cancer, melanoma in situ, cervical carcinoma in situ allowed) 3. Current hormone replacement therapy, selective estrogen receptor modulator therapy, or aromatase inhibitor therapy--if yes, wash out of 30 days must occur prior to baseline biopsy for the study 4. Recurrent ipsilateral DCIS 5. Current steroid therapy (doses for physiologic replacement in adrenal dysfunction or for contrast allergy pre-medication for contrast allergy or similar indication allowed, topical, ocular and intranasal steroids allowed) 6. Current Immunomodulator therapy (includes anti-CD20 antibodies) 7. History of autoimmune disease requiring systemic immunosuppression, or active autoimmune disease. Replacement therapy with thyroxine, insulin, and physiologic corticosteroids for adrenal or pituitary insufficiency is acceptable. 8. History of immune deficiency 9. Active infection requiring systemic therapy 10. Any medical or psychiatric condition, substance abuse disorder, medical therapy, or laboratory abnormality that might interfere with the patient's participation for the full duration of the study or compliance with the requirements of the study 11. Known active hepatitis B (hepatitis B surface antigen-reactive) or hepatitis C (hepatitis C virus RNA positive). Patients who are hepatitis B core antibody positive without hepatitis B surface antigen reactivity are eligible. Patients who have antibody for hepatitis C are eligible only if hepatitis C RNA is negative by PCR. 12. Known history of HIV (presence of HIV antibodies for HIV 1 and HIV 2). 13. Received a live vaccine within 30 days of the first dose of treatment. 14. History of allergies to any component of the MUC1 vaccine or HiltonolR adjuvant. 15. Participation on any investigational vaccine, drug, or device trial within the last 30 days.

Inclusion Criteria

Exclusion Criteria

1. Postmenopausal female, 18 years of age or older (no menstrual period for at least 12 months, or S/P oophorectomy)
2. Capable of providing informed consent and willing to comply with study procedures
3. Biopsy-proven ER+ DCIS
* The signed pathology report from the attending pathologist will be used to determine eligibility.
* At least one tissue core with DCIS must be available for research.
* Patients with DCIS suspicious for microinvasion on core biopsy will be eligible because many of these patients will not have invasion on final pathology.
* Women presenting with concurrent bilateral DCIS are eligible only if both the right and left DCIS lesions are ER+, and tissue from both sides will be analyzed and must meet the criteria below
4. DCIS must be \>=1cm based on the extent of calcifications on imaging, the presence of a mass on ultrasound or enhancement on MRI OR DCIS \>=5mm on one single core by pathologic evaluation OR DCIS \< 5mm if identified in \>=2 cores
5. Candidate for aromatase inhibitor
6. Surgery planned as part of definitive local therapy
7. ECOG PS 0-1
8. Absolute neutrophil count \>= 1.5 x 109/L
9. Platelet count \>= 100 x 109/L
10. Hemoglobin \>=9 g/dl or \>= 5.6 mmol/L
11. Creatinine \<=1.5X the upper limit of normal OR creatinine clearance \>=60 ml/min
12. Total bilirubin \<=1.5X the ULN; \<=2x ULN for patients with Gilbert's disease
13. AST and ALT \<= 2.5X ULN
14. INR/PT/aPTT \<=1.5X ULN or within the therapeutic range if on anti-coagulation

1. Invasive breast cancer \> 1mm on pathologic evaluation
2. Second malignancy within the last 5 years (definitively treated superficial non-melanoma skin cancer, melanoma in situ, cervical carcinoma in situ allowed)
3. Current hormone replacement therapy, selective estrogen receptor modulator therapy, or aromatase inhibitor therapy--if yes, wash out of 30 days must occur prior to baseline biopsy for the study
4. Recurrent ipsilateral DCIS
5. Current steroid therapy (doses for physiologic replacement in adrenal dysfunction or for contrast allergy pre-medication for contrast allergy or similar indication allowed, topical, ocular and intranasal steroids allowed)
6. Current Immunomodulator therapy (includes anti-CD20 antibodies)
7. History of autoimmune disease requiring systemic immunosuppression, or active autoimmune disease. Replacement therapy with thyroxine, insulin, and physiologic corticosteroids for adrenal or pituitary insufficiency is acceptable.
8. History of immune deficiency
9. Active infection requiring systemic therapy
10. Any medical or psychiatric condition, substance abuse disorder, medical therapy, or laboratory abnormality that might interfere with the patient's participation for the full duration of the study or compliance with the requirements of the study
11. Known active hepatitis B (hepatitis B surface antigen-reactive) or hepatitis C (hepatitis C virus RNA positive). Patients who are hepatitis B core antibody positive without hepatitis B surface antigen reactivity are eligible. Patients who have antibody for hepatitis C are eligible only if hepatitis C RNA is negative by PCR.
12. Known history of HIV (presence of HIV antibodies for HIV 1 and HIV 2).
13. Received a live vaccine within 30 days of the first dose of treatment.
14. History of allergies to any component of the MUC1 vaccine or HiltonolR adjuvant.
15. Participation on any investigational vaccine, drug, or device trial within the last 30 days.

Contacts and Locations

Study Contact

Kelsey Mitch, RN, BSN

CONTACT

412-623-6793

adamkka2@upmc.edu

Lucia Borrasso, BS

CONTACT

412-641-3304

borrlm@upmc.edu

Principal Investigator

Emilia Diego, MD

PRINCIPAL_INVESTIGATOR

UPMC Magee Women's Hospital

Study Locations (Sites)

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Finn, Olivera, PhD

Emilia Diego, MD, PRINCIPAL_INVESTIGATOR, UPMC Magee Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-07

Study Completion Date2028-08-31

Study Record Updates

Study Start Date2024-02-07

Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

T cells
cancer vaccine
immune checkpoint
lyse tumor cells

Additional Relevant MeSH Terms

Ductal Carcinoma in Situ