Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer

NCT05263492 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: MCC-21-18659HM20023447
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the efficacy of the combination of lenvatinib and pembrolizumab in Black participants

Conditions

Endometrial Cancer; Mismatch Repair-Proficient; Recurrent Endometrial Cancer

Keywords

Endometrial Cancer; Mismatch Repair-Proficient; Recurrent; Lenvatinib; Black Participants; Pembrolizumab

Outcome Measures

Primary Outcomes (1)

• Determine the Objective Response Rate (ORR) at 24 Weeks in Black Patients With Recurrent Endometrial Cancer Treated With Lenvatinib 20 mg Orally Daily in Combination With Pembrolizumab 200 mg IV Every 3 Weeks

  Number of patients evaluable for measurement of tumor response evaluated and recorded according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

  24 Weeks

Secondary Outcomes (5)

• Determine the Median Progression Free Survival (PFS)

  Up to 90 days following the last dose of study treatment

• Determine the Median Progression Free Survival (PFS)

  Up to 90 days following the last dose of study treatment

• Determine the Median Progression Free Survival (PFS)

  Up to 90 days following the last dose of study treatment

• Determine the Number of Patients With Treatment-related Adverse Events (AEs) in the Study Population

  Up to 30 days following the last dose of study treatment

• Determine the Number of Patients Who Discontinue Treatment Due to Treatment-related Adverse Events (AEs)

  up to 30 days (plus or minus 15 days) following last dose of study treatment, average of 4.75 months.

Study Arms (1)

Pembrolizumab & Lenvatinib

EXPERIMENTAL

Lenvatinib, 20 mg administered orally (PO) once daily (QD) during each 21-day cycle, and Pembrolizumab, 200 mg administered by intravenous (IV) infusion on day 1 of each 21-day cycle.

Drug: Lenvatinib; Drug: Pembrolizumab

Interventions

Lenvatinib DRUG

Lenvatinib once a day by mouth every day

Pembrolizumab & Lenvatinib

Pembrolizumab DRUG

Pembrolizumab through a needle or tube in a vein (intravenously, IV) every 3 weeks.

Pembrolizumab & Lenvatinib

Eligibility Criteria

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

You may qualify if:

• Histologically and/or cytologically confirmed endometrioid, serous, clear cell, carcinosarcoma, or de-differentiated or undifferentiated endometrial cancer with radiographic and/or clinical evidence of disease progression
• Documented microsatellite stable disease as tested by either microsatellite instability polymerase chain reaction (MSI PCR) or deoxyribonucleic acid (DNA) mismatch repair (MMR) by immunohistochemistry (IHC)
• Self-identify as being of predominantly (\>50%) Black race, inclusive of Black, African-American, Black Hispanic (Afro-Latinx), African, or Afro-Caribbean ancestry
• Received, ineligible for (by investigator determination), or declined platinum containing chemotherapy
• Received no greater than two prior lines of therapy. Maintenance therapies and hormonal therapies will NOT count as a line of therapy.
• Measurable disease as determined by RECIST v1.1:
• At least one lesion of ≥10 mm in the longest diameter for a non-lymph node, or ≥15 mm in the short-axis diameter for a lymph node that is serially measurable using computerized tomography/magnetic resonance imaging (CT/MRI)
• Target lesions limited to a radiated field must show evidence of substantial size increase according to previous scans to be deemed a target lesion
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• Ability to swallow oral medications
• Patients who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test within 72 hours prior to initiating study treatment
• Note: Postmenopausal is defined as any of the following:
• Age ≥ 60 years
• Age \< 60 years and amenorrheic for at least 1 year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range
• Bilateral oophorectomy

You may not qualify if:

• Carcinosarcoma (malignant mixed mullerian tumor), endometrial leiomyosarcoma, or endometrial stromal sarcoma
• Unstable central nervous system (CNS) metastases
• Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
• Pre-existing grade ≥3 gastrointestinal or non-gastrointestinal fistula
• Radiographic evidence of major blood vessel invasion/infiltration
• Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment
• History of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, cerebrovascular accident, stroke, or cardiac arrhythmia associated with hemodynamic instability within 12 months of the first dose of study treatment
• Known history or evidence of interstitial lung disease or active, non-infectious pneumonitis
• Administration of or condition requiring administration of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating study treatment Exception: Patients with conditions that can be managed with steroids equivalent to or less than an oral prednisone dose of 10 mg daily are not excluded from the study
• Active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents Note: Patients with the conditions or medical history listed below are not excluded from the study.
• Vitiligo
• Resolved childhood asthma/atopy
• Requirement for intermittent use of bronchodilators or local steroid injections or topical steroids
• Hypothyroidism stable on hormone replacement
• Sjogren's Syndrome

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Recurrence

Interventions

lenvatinib; pembrolizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This trial was terminated early for low accrual.

Results Point of Contact

• Title: Massey IIT Research Operations
• Organization: Virginia Commonwealth University Massey Cancer Center

masseyepd@vcu.edu

804-628-6430

Study Officials

• Chelsea Salyer, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 21, 2022
• First Posted: March 2, 2022
• Study Start: April 1, 2022
• Primary Completion: September 13, 2024
• Study Completion: October 19, 2024
• Last Updated: October 2, 2025
• Results First Posted: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)