Phase 2 Study of Pembrolizumab and Lenvatinib in Anal Squamous Cell Cancer (NCT07680088) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase 2 Study of Pembrolizumab and Lenvatinib in Anal Squamous Cell Cancer
17 participantsStarted 2026-09-30
Plain-language summary
The goal of this clinical trial is to see the safety and efficacy of pembrolizumab and lenvatinib in patients with anal squamous cell cancer that cannot be removed through surgery or is spread to other organs. Eligible participants should have also received some form of standard therapy previously for their advanced cancer.
Participants will be required to come for a clinic visit and infusion of pembrolizumab. Lenvatinib will be taken by mouth at home based on direction provided by physicians and research team.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of anal squamous cell carcinoma.
. The participants should have inoperable local recurrence or advanced cancer (stage 4; any T, any N, M1).
. The participants should have received at least one prior line of cytotoxic chemotherapy regimen in palliative setting or have declined cytotoxic chemotherapy use or have a contraindication to receive chemotherapy. Prior use of PD-1 systemic therapy is allowed
. ECOG Performance status: 0, 1 or 2.
. Adequate organ and bone marrow function as outlined below:
. A participant will be eligible for inclusion in the study if the participant:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate of pembrolizumab and lenvatinib combination
Timeframe: From time of initial treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Trial details
NCT IDNCT07680088
SponsorUniversity of Texas Southwestern Medical Center
. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
. Archival tumor tissue sample or fresh core biopsy of a tumor lesion is available. In a situation where a safe and suitable site for a fresh biopsy is not feasible and an archival tissue is not available; patients may still be eligible to enroll after discussing with UTSW PI.
Exclusion criteria
. Has received chemotherapy within 2 weeks prior to starting study treatment.
. Has received any investigational agents for the treatment of the cancer under study within 3 weeks of start of the study.
. Has received prior radiotherapy within 3 weeks of start of study intervention or suffers from radiation-related toxicities requiring corticosteroids.
. Had a major surgery within 3 weeks prior to first dose of study interventions or has not adequately recovered from a previous major surgery or has ongoing surgical complications, in the opinion of the investigator, that would limit participation in study. Note: Adequate wound healing after major surgery must be assessed clinically by investigator or qualified designee.
. Has an uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection requiring systemic antibiotic, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided participants are not on steroid treatment for the CNS metastasis at least 14 days prior to first dose of study intervention. An MRI assessment of the brain may be needed during Screening if clinically indicated as per investigator.
. Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
. Has a left ventricle ejection fraction \<45% as determined by multi-gated acquisition (MUGA) or 2D echocardiogram (ECHO). Among patients with a prior known history of congestive heart failure with a low ejection fraction, then ejection fraction assessment will be performed during screening to determine eligibility.