Pembrolizumab and Lenvatinib in Advanced Cervical Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGeorgetown University
About this trial
This is a phase II trial of combination therapy of pembrolizumab and lenvatinib in patients with locally advanced or metastatic cervical cancer that had failed first line of therapy. The hypothesis is the combination of lenvatinib and pembrolizumab will overcome vascular endothelial growth factor (VEGF)-mediated immunosuppression to enhance the response of patients with locally advanced or metastatic cervical cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of locally advanced or metastatic cervical cancer will be enrolled in this study.
Patients with progression or intolerance to at least one line of therapy in the locally advanced or metastatic setting will be eligible for this study.
Not a woman of childbearing potential (WOCBP) as defined OR
A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
Disqualifiers
A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment initiation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent.
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab
Drug200mg, every 3 weeks, IV infusion
Lenvatinib
Drug20 mg (2 capsules x10mg), daily, orally
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Pembrolizumab with LenvatinibExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate
To evaluate the clinical activity (as assessed by objective response rate \[ORR\]) of specific pembrolizumab-lenvatinib combination.
Time frame
up to 2 yearsSecondary outcomes
1
Duration of response
To evaluate the clinical activity (as assessed by duration of response (DoR)) of pembrolizumab-lenvatinib combinations. DOR: length of time tumor continues to respond to the treatment.
Time frame
up to 2 years2
Progression Free survival
To evaluate the clinical activity (as assessed by progression-free survival \[PFS\]) of pembrolizumab-lenvatinib combinations. PFS: Time from treatment initiation to the first documented disease progression per response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by local site or death, whichever occurs first.
Time frame
up to 2 years3
Overall survival
To evaluate the clinical activity (as assessed by overall survival \[OS\]) of pembrolizumab-lenvatinib combinations. OS: Time from treatment initiation to death due to any cause.
Time frame
Cycle 1 Day 1, Day 1 of each cycle (each cycle is 21 days), every 12 weeks after end of treatment4
Incidence of adverse events
To evaluate the safety and tolerability of pembrolizumab-lenvatinib combination: Number of Participants Experiencing Adverse Events (AEs) according to NCI CTCAE Version 5.0.
Time frame
Day 1 of each cycle (each cycle is 21 days), up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Georgetown University
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov