Actively Recruiting
Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)
Led by University of Texas Southwestern Medical Center · Updated on 2026-05-06
30
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of this study is to gather information about an investigational drug combination, Lenvatinib in combination with pembrolizumab, that may help to treat cervical cancers. In this study, we are looking to see whether the combination of lenvatinib and pembrolizumab has any effect on slowing tumor growth in cervical cancer tumors.
CONDITIONS
Official Title
Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Histologically confirmed squamous, adenocarcinoma, or adenosquamous cervical cancer that is recurrent or metastatic
- May have received up to two prior lines of systemic chemotherapy for advanced or recurrent cervical cancer
- May have received prior checkpoint inhibitor therapy for advanced or recurrent cervical cancer
- Prior radiation therapy allowed and not counted as a line of treatment
- Prior chemotherapy used as radiation sensitizer allowed and counted as a line of treatment
- Female participants must not be pregnant or breastfeeding and must either not be women of childbearing potential or use highly effective contraception or abstain from heterosexual intercourse during treatment and specified post-treatment periods
- Women of childbearing potential must have a negative pregnancy test within 24 hours before first dose
- Must have a PD-L1 diagnostic test of primary or recurrent archival tumor tissue
- May have progressed on anti-PD-1/L1 therapy with documented disease progression within 12 weeks of last dose
- Must have recovered to Grade 1 or baseline from adverse events due to prior anticancer therapies
- Must provide informed consent
- Must have measurable disease based on RECIST 1.1 criteria
- Must provide archival tumor tissue or new biopsy of a non-irradiated tumor lesion
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Adequate organ and marrow function based on defined laboratory criteria
- Participants with controlled Hepatitis B or C infection under specified conditions are eligible
- Adequately controlled blood pressure of 150/90 mmHg or lower
- Ability and willingness to sign informed consent
You will not qualify if you...
- Positive pregnancy test within 72 hours prior to enrollment for women of childbearing potential
- Received systemic anti-cancer therapy within 2 weeks prior to study allocation
- Received radiotherapy within 2 weeks of study intervention start or has radiation-related toxicities requiring corticosteroids
- Received live or live-attenuated vaccine within 30 days before first dose
- Received investigational agents or devices within 4 weeks prior to study intervention
- Diagnosed immunodeficiency or receiving high-dose systemic steroids or immunosuppressive therapy within 7 days prior to first dose
- Known progressing additional malignancy requiring treatment within past 5 years (except certain skin cancers and carcinoma in situ of bladder)
- Active central nervous system metastases or carcinomatous meningitis unless stable for at least 4 weeks and off steroids
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years except hormone replacement
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Known HIV infection
- Concurrent active Hepatitis B or C infection as defined
- Major surgery within 3 weeks prior to first dose
- Conditions or abnormalities interfering with study participation or results
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnant, breastfeeding, or planning conception during study and 120 days after last dose
- History of allogenic tissue or solid organ transplant
- Preexisting Grade 3 or higher gastrointestinal or non-gastrointestinal fistula
- Urine protein 1 g/24 hours or higher
- Left ventricular ejection fraction below normal institutional range
- Radiographic evidence of major blood vessel encasement or tumor cavitation
- Prolonged QTcF interval over 480 ms
- Significant cardiovascular disease within 12 months before study
- Gastrointestinal malabsorption or conditions affecting lenvatinib absorption
- Active hemoptysis within 3 weeks prior to first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
A
Annette Paulsen
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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