A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study

NCT04215146 | Active Not Recruiting Phase 2 Results FDA Drug

• 2 other identifiers: REO 028PrE0113
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 18

Brief Summary

The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy \[paclitaxel\] and avelumab in treating a type of breast cancer called Hormone Receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 negative(HER2-) breast cancer, which is either locally advanced or has metastasized (cancer that has spread in your body). The study will investigate if pelareorep in combination with paclitaxel and avelumab is more effective than paclitaxel alone, or pelareorep and paclitaxel. The safety of the combination treatments will also be evaluated.

Conditions

Breast Cancer Metastatic

Keywords

Breast; Breast Cancer; Breast Cancer Metastatic; Locally Advanced Breast Cancer; Pelareorep; Avelumab; Paclitaxel; Reovirus; Oncolytic virus; HR+ breast cancer; HER2- breast cancer; Breast malignancy

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall response rate at week 16 according to RECIST V1.1

  at week 16

Other Outcomes (4)

• The Number of Patients With Adverse Events and Serious Adverse Events

  From first day of study treatment to 30 days after of last day of study treatment; up to 27 months

• Changes in the Peripheral and Tumor T Cell Clonality.

  Up to 2 years of study treatment

• Overall Response Rate

  Up to 2 years of study participation

Study Arms (3)

Cohort 1

ACTIVE COMPARATOR

Patients receive paclitaxel alone.

Drug: Paclitaxel

Cohort 2

EXPERIMENTAL

Patients receive pelareorep + paclitaxel.

Drug: Paclitaxel; Biological: Pelareorep

Cohort 3

EXPERIMENTAL

Patients receive pelareorep + paclitaxel + avelumab.

Drug: Paclitaxel; Biological: Pelareorep; Drug: Avelumab

Interventions

Paclitaxel DRUG

Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.

Cohort 1; Cohort 2; Cohort 3

Pelareorep BIOLOGICAL

Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.

Cohort 2; Cohort 3

Avelumab DRUG

Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle.

Cohort 3

Eligibility Criteria

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

You may qualify if:

• Female patients ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Must have a histological/cytological diagnosis of breast cancer. Disease must be:
• Positive for estrogen receptor (ER) and/or progesterone receptor (PgR) as defined by
• ≥ 1% tumor cell nuclei immunoreactive.
• Negative for HER2 amplification / overexpression as defined per the American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines. However, patients with HER2 equivocal disease for whom HER2 targeted therapy isn't indicated are also eligible for enrollment.
• ECOG performance status of 0-1
• Must have unresectable locally advanced or metastatic disease, for which no curative therapy exists and for which systemic chemotherapy is indicated.
• Measurable disease as defined by RECIST Version 1.1
• Prior Hormonal Therapy:
• Patients must have progressed on at least 1 hormone-based therapy with a CDK4/6 inhibitor. Patients who received a CDK4/6 inhibitor in the adjuvant setting and progressed while on or within 6 months of discontinuation of CDK4/6 inhibitor therapy are eligible.
• Prior mTOR inhibitor therapy is allowed but is not required.
• Ability to understand and willingness to sign IRB-approved informed consent.
• Willing to provide blood samples for research
• Adequate organ function as measured by the following criteria, obtained ≤ 2 weeks prior to registration:
• Hematology:

You may not qualify if:

• No major surgery within 21 days prior to beginning study treatment. Major surgery \>21 days prior to beginning study treatment is permitted provided that the patient has recovered adequately to receive systemic chemotherapy. NOTE: Placement of a vascular access device is not considered major surgery.
• Patients who have received radiation treatment within 14 days of beginning study treatment are excluded. Patients who have received palliative radiation ≥ 14 days prior to beginning study treatment may enroll if they have recovered from all local and systemic side effects to ≤ Grade 1 (NCI-CTCAE).
• No prior chemotherapy in the advanced/metastatic setting is allowed. Patients may have received chemotherapy in the (neo)adjuvant setting. Patients receiving (neo)adjuvant taxanes must have a disease-free interval of at least 12 months.
• No known active, uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms,cerebral edema, and/or progressive growth. Patients with CNS metastases treated with radiation therapy (Whole-Brain Radiation Therapy \[WBXRT\] or Stereotactic Radiotherapy \[SRS\]) are eligible if, \>28 days following completion of XRT, they show stable disease on post-treatment MRI/CT, are off corticosteroids, and are neurologically stable.
• No known history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumors curatively treated with no evidence of disease for \>3 years.
• Not on chronic immunosuppressive therapy including, but not exclusively, steroids (≥ 10 mg prednisone a day or equivalent) or monoclonal antibodies, chronic methotrexate or cyclophosphamide, tacrolimus or sirolimus.
• No known HIV infection. Testing not required in absence of clinical suspicion.
• No known active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection or undergoing anti-viral treatment. Testing for HBV/HCV is not required in absence of clinical suspicion.
• No concurrent disease or condition that would interfere with study participation or safety,such as any of the following:
• Active, clinically significant infection either Grade \>2 by CTCAE V5.0 or requiring the use of parenteral anti-microbial agents within 14 days before registration.
• No active or history of any autoimmune disease (patients with diabetes Type 1, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.
• Patients may not have evidence of uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III or higher), unstable angina, or myocardial infarction within the past 6 months prior to registration. NOTE: Patients with asymptomatic rate-controlled atrial fibrillation may participate.
• Patients may not have other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the Investigator, might impair the patient's tolerance of trial treatment.
• Patients with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent are not eligible.
• Patients who have contraindications to treatment with paclitaxel and/or neuropathy \>Grade 2 are not eligible.

Sponsors & Collaborators

• Oncolytics Biotech: lead
• PrECOG, LLC.: collaborator

Study Sites (18)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Roswell Park

Buffalo, New York, 14263, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Medical Park

The Bronx, New York, 10461, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

VCU/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; reolysin; avelumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Oncolytics Biotech Inc.

info@oncolyticsbiotech.com

(403) 670-7377

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: January 2, 2020
• Study Start: June 10, 2020
• Primary Completion: August 1, 2022
• Study Completion: June 1, 2025
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2025-01

Locations

US (18)