Pembrolizumab + Lenvatinib for Advanced Cervical Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not be on certain therapies like systemic steroids or immunosuppressive drugs shortly before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Pembrolizumab and Lenvatinib for advanced cervical cancer?
Research shows that Pembrolizumab, when used alone, has shown promise in treating advanced cervical cancer, with some patients experiencing prolonged response and stable disease. Additionally, the combination of Pembrolizumab and Lenvatinib has demonstrated effectiveness in treating other types of advanced cancers, such as endometrial cancer, suggesting potential benefits for cervical cancer as well.12345
Is the combination of pembrolizumab and lenvatinib generally safe for humans?
The combination of pembrolizumab and lenvatinib has been studied in patients with endometrial cancer, and the safety profile is generally consistent with each drug used alone. Common side effects include high blood pressure, low thyroid function, diarrhea, nausea, vomiting, loss of appetite, tiredness, and weight loss.678910
How is the drug combination of pembrolizumab and lenvatinib unique for treating advanced cervical cancer?
The combination of pembrolizumab and lenvatinib is unique because it pairs an immune checkpoint inhibitor (pembrolizumab) with a multikinase inhibitor (lenvatinib), potentially offering a novel approach to treating advanced cervical cancer by targeting both the immune system and cancer cell growth pathways.23111213
What is the purpose of 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.
Research Team
Samir Khleif, MD
Principal Investigator
Georgetown University
Eligibility Criteria
This trial is for women at least 18 years old with advanced cervical cancer that worsened after first-line therapy. They must have measurable disease, provide a tumor tissue sample, and have proper organ function. Women of childbearing potential must agree to contraception guidelines. Exclusions include severe allergies to the drugs tested, recent other treatments or vaccines, certain health conditions like uncontrolled blood pressure or active infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab and lenvatinib combination therapy. The treatment is administered in cycles, with each cycle lasting 21 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of overall survival and progression-free survival.
Treatment Details
Interventions
- Lenvatinib
- Pembrolizumab
Lenvatinib is already approved in United States, European Union for the following indications:
- Differentiated Thyroid Cancer
- Renal Cell Carcinoma
- Hepatocellular Carcinoma
- Endometrial Cancer
- Thyroid Cancer
- Renal Cell Carcinoma
- Hepatocellular Carcinoma
- Endometrial Cancer
- Renal Cell Carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Georgetown University
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University