A Phase 2A, Prospective, Open Label, Single Institution Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)
Overview
- Phase
- Phase 2
- Intervention
- Pembrolizumab
- Conditions
- Cervix Cancer
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Detailed Description
Dose of pembrolizumab : The planned dose of pembrolizumab for this study is 200 mg every 3 weeks (Q3W). for a total of 35 cycles of pembrolizumab. Participants who complete study intervention after 2 years of pembrolizumab are eligible for up to 1 year of additional pembrolizumab (second course) upon experiencing disease progression. Lenvatinib Dosing Regimen: lenvatinib 20 mg/day plus pembrolizumab 200 mg Q3W.
Investigators
Jayanthi Lea
Professor /Division Chief -Obstetrics & Gynecology - OB-Gynecologic Oncology
University of Texas Southwestern Medical Center
Eligibility Criteria
Inclusion Criteria
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •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:
- •A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •Not a woman of childbearing potential (WOCBP)
Exclusion Criteria
- •Participants are excluded from the study if any of the following criteria apply:
- •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.
- •Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.
- •Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to allocation.
- •Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
- •Note: 2 weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted.
- •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.
- •Note: please refer to Section 4.9 for information on COVID-19 vaccines.
- •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.
Arms & Interventions
Pembrolizumab and Lenvatinib Arm
Pembrolizumab 200 mg q 3 weeks IV Lenvatinib 20 mg PO QD Continue q3 weeks Pembrolizumab and Lenvatinib will be given together in this trial for a maximum of 2 years i.e. a total of 35 cycles of pembrolizumab with the q3 week dosing and Lenvatinib daily. Participants who complete study intervention after 2 years of pembrolizumab and lenvatinib are eligible for up to 1 year of additional pembrolizumab and lenvatinib (second course) upon experiencing disease progression.
Intervention: Pembrolizumab
Pembrolizumab and Lenvatinib Arm
Pembrolizumab 200 mg q 3 weeks IV Lenvatinib 20 mg PO QD Continue q3 weeks Pembrolizumab and Lenvatinib will be given together in this trial for a maximum of 2 years i.e. a total of 35 cycles of pembrolizumab with the q3 week dosing and Lenvatinib daily. Participants who complete study intervention after 2 years of pembrolizumab and lenvatinib are eligible for up to 1 year of additional pembrolizumab and lenvatinib (second course) upon experiencing disease progression.
Intervention: Lenvatinib
Outcomes
Primary Outcomes
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1
Time Frame: Baseline up to approximately 36 months
Objective Response (ORR) is defined as a confirmed complete response (CR), partial response (PR) or stable disease (SD) according to Recist (Response Evaluation Criteria in Solid Tumors) v1.1.
Secondary Outcomes
- Progression Free Survival (PFS) assessed by Response Evaluation Criteria in Solid Tumors v1.1(PFS is defined as the time from the first dose date until the date of the first documented disease progression, or death up to 36 months)