Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer

NCT06860815 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 23768NCI-2025-00340P30CA033572
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial tests how well cemiplimab and transarterial radioembolization (TARE) with yttrium-90 (Y90) SIR-Spheres, registered trademark, works in treating breast cancer that has spread from where it first started (primary site) to the liver (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. TARE is a treatment that uses radioactive microspheres, such as Y90 SIR-S Spheres, to both cause hepatic artery embolization and to deliver regional radiotherapy. Y90 SIR-S Spheres is an injectable form of the radioisotope yttrium Y 90 encapsulated in resin microspheres. When injected into the artery supplying the tumor, yttrium Y 90 resin microspheres block the tumor blood vessels and deliver the yttrium Y 90 directly to the tumor site, which may kill or slow tumor growth. Giving cemiplimab and Y90 SIR-Spheres by TARE to the tumor in the liver may kill more tumor cells in patients with metastatic breast cancer.

Conditions

Metastatic Breast Carcinoma; Metastatic Carcinoma in the Liver; Anatomic Stage IV Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (3)

• CD8+ T cell infiltration in tumor microenvironment (TME): baseline

  Will be analyzed using multiplex immunofluorescence (IF) of formalin-fixed paraffin-embedded (FFPE) tissue. Will estimated the mean and standard deviation of the percent change.

  At baseline

• CD8+ T cell infiltration in tumor microenvironment (TME): post TARE -1 (day 21)

  Will be analyzed using multiplex immunofluorescence (IF) of formalin-fixed paraffin-embedded (FFPE) tissue. Will estimated the mean and standard deviation of the percent change.

  At Post-transarterial radioembolization TARE -1 (day 21)

• CD8+ T cell infiltration in tumor microenvironment (TME): prior to TARE-2 (day 42)

  Will be analyzed using multiplex immunofluorescence (IF) of formalin-fixed paraffin-embedded (FFPE) tissue. Will estimated the mean and standard deviation of the percent change.

  At prior to TARE-2 (day 42)

Secondary Outcomes (12)

• Incidence of adverse events

  Up to 30 days after last dose of study treatment

• T cell activation in TME: baseline

  At baseline

• T cell activation in TME: post-TARE-1 (day 21)

  At Post-transarterial radioembolization TARE -1 (day 21)

• T cell activation in TME: prior to TARE-2 (Day 42)

  At prior to TARE-2 (Day 42)

• Dendritic cell activation in TME: baseline

  At baseline

Study Arms (1)

Treatment (cemiplimab, Y90 SIR-Spheres, TARE)

EXPERIMENTAL

Patients receive cemiplimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive Y90 SIR-Spheres intratumorally via TARE over 60-90 minutes once during days 7-14 and on day 67. Patients also undergo tumor biopsy at baseline and at day 42 after immunotherapy begins. Additionally patients also undergo blood sample collection and CT or MRI throughout the study.

Procedure: Biopsy; Procedure: Biospecimen Collection; Biological: Cemiplimab; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Radiation: Transarterial Radioembolization; Radiation: Yttrium Y 90 Resin Microspheres

Interventions

Biopsy PROCEDURE

Undergo tumor biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (cemiplimab, Y90 SIR-Spheres, TARE)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (cemiplimab, Y90 SIR-Spheres, TARE)

Cemiplimab BIOLOGICAL

Given IV

Also known as: Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN 2810, REGN-2810, REGN2810

Treatment (cemiplimab, Y90 SIR-Spheres, TARE)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (cemiplimab, Y90 SIR-Spheres, TARE)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (cemiplimab, Y90 SIR-Spheres, TARE)

Transarterial Radioembolization RADIATION

Undergo TARE

Also known as: Hepatic Radioembolization, TARE, Transarterial Hepatic Radioembolization

Treatment (cemiplimab, Y90 SIR-Spheres, TARE)

Yttrium Y 90 Resin Microspheres RADIATION

Given intratumorally

Also known as: SIR-Spheres, Y-90 Sirsphere

Treatment (cemiplimab, Y90 SIR-Spheres, TARE)

Eligibility Criteria

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

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative.
• Assent, when appropriate, will be obtained per institutional guidelines
• Agreement to allow the use of archival tissue from diagnostic tumor biopsies
• If unavailable, exceptions may be granted with study principal investigator (PI) approval
• Age: ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) 0-1
• Must have a life expectancy of at least 12 weeks
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
• Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
• Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy)
• Male patients must be surgically sterile, or if sexually active and having a pre-menopausal female partner then must be using an acceptable form of contraception
• Patients with metastatic breast cancer, previously treated with ≥ 1 line of chemotherapy in metastatic setting
• Candidate for TARE based on evaluation by board certified interventional radiologist; must have measurable metastatic liver disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.1; not all liver tumors will be treated with TARE in a single session
• Liver tumor burden \< 50%
• No radiographic or clinical evidence of cirrhosis

You may not qualify if:

• Prior immunotherapy in the past 12 months
• Progressing or untreated extra-hepatic metastatic disease
• Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy
• Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• Portal vein invasion
• Evidence of diffuse metastatic disease (tumor burden occupying \> 50% of liver)
• Major surgical procedure (as defined by the investigator) within 28 days prior to radioembolization. Note: Local surgery of isolated lesions for palliative intent is acceptable
• Participation in another clinical study with an investigational product during the last 4 weeks
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
• Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤ 28 days prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or pharmacokinetics (PK) properties of an agent, a longer wash-out period will be required, as agreed by Regeneron and the investigator
• Prior exposure to anti-PD-1/PD-L1 inhibitor or anti-CTLA4 inhibitor, including cemiplimab in the past 12 months
• Patients with grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician
• Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with cemiplimab may be included only after consultation with the study physician
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). The following are exceptions to this criterion: Patients with vitiligo or alopecia; patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; any chronic skin condition that does not require systemic therapy; patients without active disease in the last 5 years may be included but only after consultation with the study physician; patients with celiac disease that is controlled by diet alone
• History of allogeneic organ transplantation

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy; Specimen Handling; cemiplimab; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Jonathan Kessler

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: March 6, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)