Actively Recruiting
A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-13
54
Participants Needed
7
Research Sites
200 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test whether the combination of lenvatinib, pembrolizumab, and fulvestrant is a safe and effective treatment that causes few or mild side effects in people with ER+/HER2- metastatic breast cancer.
CONDITIONS
Official Title
A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with histologically confirmed unresectable locally advanced or metastatic breast cancer
- Male participants or premenopausal females must be on LHRH agonist for at least four weeks before starting therapy and agree to continue it during treatment
- Diagnosed with ER-positive (ER >1%), HER2-negative breast cancer per ASCO/CAP guidelines
- Progressed on at least one prior endocrine therapy combined with CDK 4/6 inhibitor; prior fulvestrant therapy allowed
- Have not had more than two lines of chemotherapy in the metastatic setting
- Stable previously treated brain metastases without progression for at least four weeks and clinically stable without steroid treatment
- Life expectancy of at least 12 weeks
- Availability of a new biopsy of non-irradiated tumor or archival tissue within 6-12 months for biomarker analysis
- Provide written informed consent
- Have measurable disease based on RECIST 1.1 criteria
- ECOG performance status of 0 to 1 assessed within 7 days prior to first dose
- Adequately controlled blood pressure (≤150/90 mm Hg) with or without antihypertensive medications
- Adequate organ function based on laboratory tests within 14 days before starting treatment
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or use effective contraception during and after the intervention
- Male participants must agree to use contraception or be abstinent during the intervention and for 7 days after last lenvatinib dose
- Participants with controlled hepatitis B or C infection under specified conditions are eligible
- Laboratory values must meet defined hematological, renal, hepatic, and coagulation criteria
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or other stimulatory/co-inhibitory T-cell receptor agents
- Prior exposure to lenvatinib or other VEGF-directed anti-angiogenic agents
- Systemic anti-cancer therapy including investigational agents within 2 weeks prior to allocation
- Radiotherapy within 2 weeks before study intervention start, unless specific palliative radiation conditions are met
- Live or live-attenuated vaccine within 30 days before first dose
- Participation in another investigational study or use of investigational device within 2 weeks prior to first dose
- Immunodeficiency or chronic systemic steroid therapy >10 mg prednisone equivalent within 7 days before first dose
- Known additional malignancy requiring treatment within past 3 years (certain skin cancers excepted)
- Active CNS metastases or carcinomatous meningitis; stable brain metastases allowed under conditions
- History or evidence of active pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring antibiotics
- Known HIV infection
- Inability to swallow capsules
- Conditions that may interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant, breastfeeding, or planning to conceive during study and 120 days after last dose
- History of allogenic tissue or solid organ transplant
- Gastrointestinal conditions affecting lenvatinib absorption
- Significant recent bleeding or cardiovascular impairments
- Left ventricular ejection fraction below 50%
- Prolonged QTcF interval >480 ms
- Significant vascular diseases requiring surgery
- Active autoimmune disease requiring systemic treatment in past 2 years (except psoriasis)
- Known intolerance to study drugs
- Major surgery within 3 weeks prior to first dose
- Preexisting Grade 3 or higher gastrointestinal or non-gastrointestinal fistulas
- Urine protein ≥1 g/24 hours
- Radiographic evidence of major blood vessel invasion or tumor cavitation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
S
Sherry Shen, MD
CONTACT
K
Komal Jhaveri, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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