Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix) (NCT06266338) | Clinical Trial Compass
RecruitingPhase 2
Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)
United States30 participantsStarted 2024-03-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female participants who are at least 18 years of age on the day of signing informed consent.
✓. Histologically confirmed diagnosis of squamous, adenocarcinoma or adenosquamous cervical cancer, that is recurrent or metastatic.
✓. Prior therapy: May have received up to 2 prior lines of systemic chemotherapy in the setting of advanced, metastatic (Stage IVB) or recurrent cervical cancer. May have received prior checkpoint inhibitor for advanced, metastatic (Stage IVB) or recurrent cervical cancer. May have received prior bevacizumab or antiangiogenic agent for recurrent or metastatic cervical cancer,
✓. Include whether prior checkpoint inhibitor was used in first line setting or second line setting.
✓. Prior Radiation therapy will be allowed and not counted as a line of treatment.
✓. Prior chemotherapy used as radiation sensitizer (e.g. cisplatin) used as treatment during chemoradiation will be allowed and counted as a line of treatment.
✓. Female participants:
✓. Participants must have a PD-L1 diagnostic test of primary or recurrent archival tumor tissue.
Exclusion criteria
✕. A WOCBP who has a positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
✕. Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to allocation.
What they're measuring
1
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1
Timeframe: Baseline up to approximately 36 months
Trial details
NCT IDNCT06266338
SponsorUniversity of Texas Southwestern Medical Center
✕. Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
✕. 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.
✕. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
✕. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within seven days prior to the first dose of study drug.
✕. Known additional malignancy that is progressing or has required active treatment within the past five years.
✕. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.