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.
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.
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.
Single group
Lenvatinib
Drug20 mg orally daily on days 1-21
Pembrolizumab
Drug200 mg every Day 1 Intravenous every 21 days
Objective response rate of pembrolizumab and lenvatinib combination
To determine the objective response rate (ORR) of Pembrolizumab and Lenvatinib combination. The objective response rate is defined as the rate of CR + PR as the best response on evaluation; measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. RECIST Criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions. Progressive Disease (PD): \> 20% increase in the SLD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Disease control with pembrolizumab and lenvatinib combination
To describe the disease control with pembrolizumab and lenvatinib combination in refractory anal squamous cell cancers. The disease control rate as per iRECIST is defined as the rate of iCR + iPR + iSD as the best response on evaluation. iRECIST Criteria (Prefix "i" indicates immune responses assigned using iRECIST): iCR (Immune Complete Response): Complete disappearance of all target and non-target lesions. iPR (Immune Partial Response): At least a 30% decrease in the sum of diameters of target lesions. iSD (Immune Stable Disease): Tumors do not meet the criteria for iPR or iCPD.
Frequency of adverse events
To describe the adverse events associated with pembrolizumab and lenvatinib combination in refractory anal squamous cell cancers. 2.4.2.2 Frequency of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
