A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06110793
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    20mg orally PO daily
  • Pembrolizuma — DRUG
    400mg IV Q6W
  • Fulvestrant — DRUG
    500mg IM Q4W

Study Details

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.

Key Dates

Start date
Dec 29, 2023
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lenvatinib, Pembrolizumab, and Fulvestrant
    This is an open-label phase Ib/II trial of lenvatinib (20mg orally PO daily) plus pembrolizumab (400mg IV Q6W) plus fulvestrant (500mg IM Q4W) in patients with unresectable, locally advanced/metastatic ER+/HER2- breast cancer.

Primary Outcome Measure

The number of adverse events and dose-limiting toxicities to find the Recommended Phase 2 Dose (RP2D) [ Time Frame: 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Sherry Shen, MD
646-888-5299
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Sherry Shen, MD
646-888-5299
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Sherry Shen, MD
646-888-5299
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Sherry Shen, MD
646-888-5299
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Sherry Shen, MD
646-888-5299
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Sherry Shen, MD
646-888-5299
Sherry Shen, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Sherry Shen, MD
646-888-5299

Find similar trials in Basking Ridge, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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