Triple-Drug Combo for Ovarian Cancer
Trial Summary
What is the purpose of this trial?
This phase II clinical trial studies the effect of lenvatinib, pembrolizumab, and paclitaxel in treating patients with endometrial, epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). While all 3 study drugs are FDA approved, and 2-drug combinations have been studied, the 3- drug combination has not been studied yet. The investigators believe that the addition of pembrolizumab to weekly paclitaxel and lenvatinib (or weekly paclitaxel to pembrolizumab and lenvatinib) is highly effective and safe with manageable side effects in both recurrent endometrial and platinum resistant ovarian cancer. The purpose of this trial is to study how well lenvatinib, pembrolizumab, and weekly paclitaxel work together in women who have recurrent endometrial cancer and/or recurrent platinum resistant ovarian, fallopian tube, and primary peritoneal cancer, and what kind of side effects patients may experience.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received certain cancer treatments or investigational drugs within a specific time frame before starting the trial. It's best to discuss your current medications with the trial team to understand any potential interactions.
What data supports the effectiveness of the drug combination Lenvatinib, Paclitaxel, and Pembrolizumab for ovarian cancer?
Research shows that paclitaxel, when combined with other drugs like navicixizumab, has shown benefits in treating platinum-resistant ovarian cancer. Additionally, pembrolizumab has been evaluated in combination with other drugs for similar conditions, suggesting potential effectiveness in combination therapies.12345
What safety data exists for the triple-drug combo treatment for ovarian cancer?
The combination of lenvatinib and pembrolizumab has shown a safety profile with common side effects like high blood pressure, low thyroid function, diarrhea, nausea, vomiting, loss of appetite, fatigue, and weight loss. Lenvatinib and paclitaxel together have been studied for ovarian cancer, focusing on finding the right dose and understanding side effects.678910
What makes the triple-drug combo for ovarian cancer unique?
The triple-drug combo for ovarian cancer is unique because it combines Lenvatinib, Paclitaxel, and Pembrolizumab, which includes an antiangiogenic agent (Lenvatinib) and an immune checkpoint inhibitor (Pembrolizumab), potentially offering a novel approach by targeting both tumor blood supply and the immune system, unlike the standard platinum-taxane combinations.511121314
Research Team
Floor Backes, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
This trial is for women at least 18 years old with recurrent endometrial, ovarian, fallopian tube, or primary peritoneal cancer who have had platinum-based treatment. They must not be pregnant or breastfeeding and should have an acceptable organ function. Prior treatments are allowed under certain conditions but no recent severe side effects from similar drugs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lenvatinib, pembrolizumab, and paclitaxel. Lenvatinib is taken orally daily, pembrolizumab is administered intravenously on day 1, and paclitaxel is administered intravenously on days 1, 8, and 15 of a 21-day cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lenvatinib
- Paclitaxel
- 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?
Floor Backes, MD
Lead Sponsor
Floor Backes
Lead Sponsor