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OncoMatch/Clinical Trials/NCT06266338

Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)

Is NCT06266338 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Lenvatinib for cervix cancer.

Phase 2RecruitingUniversity of Texas Southwestern Medical CenterNCT06266338Data as of May 2026

Treatment: Pembrolizumab · LenvatinibThe 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.

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Extracted eligibility criteria

Cancer type

Cervical Cancer

Biomarker criteria

Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)

Disease stage

Required: Stage IVB

Metastatic disease required

recurrent or metastatic. Measurable disease based on RECIST 1.1

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines

Cannot have received: systemic anti-cancer therapy

Exception: within 2 weeks prior to allocation

Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to allocation.

Cannot have received: radiotherapy

Exception: within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. 2 weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted.

Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.

Cannot have received: live vaccine or live-attenuated vaccine

Exception: within 30 days before the first dose of study intervention. Killed vaccines allowed.

Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.

Cannot have received: investigational agent or device

Exception: within 4 weeks prior to study intervention administration

Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.

Lab requirements

Blood counts

Adequate organ and marrow function as defined in the following table (Table 2). Specimens must be collected within 10 days prior to the start of study intervention.

Kidney function

Adequate organ and marrow function as defined in the following table (Table 2). Specimens must be collected within 10 days prior to the start of study intervention.

Liver function

Adequate organ and marrow function as defined in the following table (Table 2). Specimens must be collected within 10 days prior to the start of study intervention.

Cardiac function

LVEF below institutional normal range (MUGA or ECHO) excluded; QTcF >480 ms excluded; clinically significant cardiovascular disease within 12 months excluded.

Have adequate organ and marrow function as defined in the following table (Table 2). LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO) [excluded]. Prolongation of QTcF interval to >480 ms [excluded]. Clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability [excluded].

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UT Southwestern Medical Center · Dallas, Texas

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