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New treatment option for Anatomic Stage IV Breast Cancer AJCC v8
Official title Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06860815
What this study is testing
What is Cemiplimab?
Cemiplimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anatomic stage iv breast cancer ajcc v8.
Also referred to as Cemiplimab RWLC, Cemiplimab-rwlc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- Portal vein invasion
- Evidence of diffuse metastatic disease (tumor burden occupying \> 50% of liver)
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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 treatment radiologist; must have measurable metastatic liver disease, defined as at least one lesion that can be accurately measured in at least one dimension...
- Liver tumor burden \< 50%
- No radiographic or clinical evidence of cirrhosis
- Other treated stable metastases are allowed, including treated stable brain metastases
- Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
- Body weight \> 30 kg
- No untreated, active hepatitis
- Hemoglobin ≥ 9.0 g/dL (within 14 days prior to day 1 of protocol therapy unless otherwise stated)
- Absolute neutrophil count (ANC) ≥ 1500/uL (within 14 days prior to day 1 of protocol therapy unless otherwise stated)
- Platelet count ≥ 75000/uL (within 14 days prior to day 1 of protocol therapy unless otherwise stated)
- Total bilirubin \< 2.0mg/dL (within 14 days prior to day 1 of protocol therapy unless otherwise stated)
- Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT/serum glutamic pyruvic transaminase [SGPT]) ≤ 5 x upper limit of normal (ULN) (within 14 days prior to...
- Albumin ≥ 2.8 g/dL (within 14 days prior to day 1 of protocol therapy unless otherwise stated)
- International normalized ration (INR) ≤ 1.6 (within 14 days prior to day 1 of protocol therapy unless otherwise stated)
- Measured creatinine clearance (CL) \> 40 mL/min or calculated creatinine CL \> 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance...
What rules you out
- 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-treatment) clinical study or during the follow-up period of an treatment 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...
- Prior exposure to anti-PD-1/PD-L1 inhibitor or anti-CTLA4 inhibitor, including cemiplimab in the past 12 months
- Any unresolved toxicity National Cancer Institute (NCI) CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- 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...
- History of allogeneic organ transplantation
- Expected radiation lung dose of \> 30Gy
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study treatment and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- History of active primary immunodeficiency or acquired human immunodeficiency virus (HIV/AIDS)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the...
- Active systemic infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis (TB) testing in line with local practice. Use of...
- History of leptomeningeal carcinomatosis
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
- Any concurrent chemotherapy, intraperitoneal (IP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is...
- Current or prior use of immunosuppressive medication within 14 days before the first dose of cemiplimab. The following are exceptions to this criterion: Intranasal, inhaled, topical steroid or local steroid injections...
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 120 days (4 months) after the last dose of...
- Female people, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception, as per investigator discretion during the study. The rhythm method is not to be used as the sole method of...
- Male people, unwillingness to practice effective contraception (per Investigator discretion) while taking part in this study, because the effects of the SIR-Spheres treatment on sperm or upon the development of an...
- Inability or unwillingness to understand or sign a written informed consent document
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
- Presence of cardiovascular disease, as defined by:
- New York Heart Association heart failure classifications of class II, III, or IV; or myocardial infarction, or acute coronary syndrome within 12 months of first dose of study medication; or
- Transient ischemic attack or stroke within 1 year
- Any condition that requires ongoing/continuous corticosteroid therapy (\> 10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study medication. Participants who require a brief...
- Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
- Note: The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not...
- Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication
- Uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and/or tuberculosis (active or latent)
- Participants with known controlled HIV infection (undetectable viral load on HIV ribonucleic acid [RNA] polymerase chain reaction [PCR]) and CD4 count above 350 either spontaneously or on a stable antiviral regimen are...
- Participants with hepatitis B surface antigen (HBsAg) positive who have controlled infection (serum hepatitis B virus [HBV] deoxyribonucleic acid [DNA] PCR that is below the limit of detection and receiving anti-viral...
- Participants with HBsAg negative but total hepatitis B core antibody (HBcAb) positive are permitted with the following requirements: If serum HBV DNA PCR is above the limit of detection at screening, initiate HBV...
- Participants who are hepatitis C virus (HCV) antibody positive (Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are...
- Receipt of a live vaccine within 4 weeks of start of study medication
- Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication
- Known hypersensitivity to the active substances or to any of the excipients
- Women of childbearing potential (WOCBP) and men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the...
- Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition...
- Intrauterine device; intrauterine hormone-releasing system;
- Bilateral tubal occlusion/ligation;
- Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the...
- Sexual abstinence
- Pregnancy testing and contraception are required for WOCBP. Pregnancy testing and contraception are not required for women who are postmenopausal or permanently sterile
- WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral...
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal...
- Male participants: A male participant will be excluded from the study if that participant does not agree to use condoms or practice sexual abstinence, unless vasectomized, prior to the initial dose/start of study...
- Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual...
- Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.