Cemiplimab + Y-90 SIR-Spheres for Liver Metastases from Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByJonathan Kessler

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with breast cancer that has spread to the liver. Participants should have a type of breast cancer suitable for this treatment and must be able to undergo procedures like CT scans, MRIs, biopsies, and radioembolization.

Inclusion Criteria

I do not have cirrhosis.

My kidneys are functioning well.

I am 18 years old or older.

I am fully active or have some restrictions but can still carry out work.

I weigh more than 30 kg.

I have metastatic breast cancer and have been treated with chemotherapy.

I am eligible for a specific liver cancer treatment as determined by a specialist.

I have recovered from side effects of previous cancer treatment.

Less than half of my liver is affected by cancer.

I do not have active, untreated hepatitis.

Exclusion Criteria

I have received immunotherapy within the last year.

I am not pregnant, breastfeeding, and willing to use birth control if of childbearing potential.

My cancer has spread to the vein leading to my liver.

I have not had major surgery in the last 28 days.

I received my last cancer treatment less than 28 days ago.

I have been treated with specific immune therapies within the last year.

My lung will receive more than 30Gy of radiation.

I have had cancer before, but it fits the exceptions.

I am not currently on any cancer treatments like chemotherapy or hormone therapy.

I have heart disease.

I am on continuous corticosteroid therapy for a health condition.

I haven't been hospitalized or needed IV antibiotics in the last 2 weeks.

I do not have an uncontrolled HIV, hepatitis B, or hepatitis C infection.

I am not willing to use effective birth control methods.

My cancer has spread beyond the liver and is getting worse.

I have or had an autoimmune or inflammatory disorder.

I have an autoimmune disease or condition that requires me to take medication to suppress my immune system.

My cancer has spread widely throughout my body.

I don't have lasting side effects from cancer treatment worse than grade 2.

I currently have an active infection, including TB.

I have had cancer spread to the lining of my brain and spinal cord.

I have an active autoimmune disease.

I have not received a live vaccine in the last 4 weeks.

Participant Groups

The study is testing the combination of cemiplimab (an immune system-boosting drug) with Y90 SIR-Spheres (radioactive microspheres) delivered directly into the liver's blood vessels to treat metastatic breast cancer in the liver.

1Treatment groups

Experimental Treatment

Group I: Treatment (cemiplimab, Y90 SIR-Spheres, TARE)Experimental Treatment7 Interventions

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.