Pembrolizumab + Lenvatinib for Endometrial Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of two drugs, Pembrolizumab and Lenvatinib, in treating endometrial cancer that has returned after standard treatments. The main goal is to determine if this combination is safe and effective for individuals whose cancer did not respond to previous treatments, specifically those with "mismatch repair-proficient" cancer. Suitable candidates for this trial have experienced a recurrence of endometrial cancer after initial chemotherapy and have a confirmed cancer type that meets the study's criteria. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering early access to potentially effective therapies.
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, you cannot be on other investigational drugs or anti-cancer therapies, except for certain hormonal therapies for breast cancer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of pembrolizumab and lenvatinib is generally well-tolerated by patients with advanced endometrial cancer. Studies have found that patients lived longer compared to those receiving traditional chemotherapy. For example, one study reported a 16.7% survival rate at five years for patients with a specific type of endometrial cancer called mismatch repair-proficient (pMMR).
Safety data from other studies highlight that while this combination can be effective, it may cause side effects. Common side effects include tiredness, high blood pressure, and nausea, but these were generally manageable. Importantly, another study suggested that starting with a lower dose of lenvatinib might help reduce these side effects while still being effective.
Overall, the combination of pembrolizumab and lenvatinib has shown promising results in terms of safety and effectiveness for patients with advanced endometrial cancer.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Pembrolizumab combined with Lenvatinib for treating endometrial cancer because this duo offers a fresh approach compared to standard treatments. Unlike traditional chemotherapy, which attacks cancerous and healthy cells alike, Pembrolizumab is an immunotherapy that helps the immune system recognize and target cancer cells more effectively. Lenvatinib adds another layer by inhibiting the growth of blood vessels that tumors need to thrive. This combination has the potential to be more precise and less harsh than existing options, offering hope for better outcomes in patients who haven't responded to first-line treatments.
What evidence suggests that Pembrolizumab and Lenvatinib could be effective for endometrial cancer?
Research has shown that using Pembrolizumab and Lenvatinib together can help treat advanced endometrial cancer. In this trial, participants will receive this combination after first-line therapy with a platinum-based doublet chemotherapy and immunotherapy fails. Studies found that about 4 out of 10 patients experienced their cancer shrinking or disappearing with this treatment. This combination also helped patients live longer without their cancer worsening compared to those who received chemotherapy. After five years, some patients were still alive, with a survival rate of 16.7%. Early results suggest this treatment could be a promising option for those with advanced endometrial cancer.12567
Who Is on the Research Team?
Navya Nair, MD, MPH
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for people with endometrial cancer that has come back and whose tumors are mismatch repair-proficient. Participants must have already tried platinum-based chemotherapy and immunotherapy, but their cancer did not respond or came back after these treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Pembrolizumab in combination with Lenvatinib after failure of first-line therapy with a platinum-based doublet chemotherapy and immunotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lenvatinib
- Pembrolizumab
Trial Overview
The study is testing the combination of two drugs, Pembrolizumab (an immunotherapy) and Lenvatinib (a targeted therapy), to see how well they work together in treating this type of recurrent endometrial cancer.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive Pembrolizumab in combination with Lenvatinib after failure of first-line therapy with a platinum-based doublet chemotherapy in combination with immunotherapy. Participants may receive treatment for a total of up to approximately 24 months, or until participants have progression of disease or experience a Grade 4 or higher severe adverse event (SAE). Total participation duration is approximately 26 months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Citations
Lenvatinib plus Pembrolizumab for Advanced Endometrial ...
Lenvatinib plus pembrolizumab led to significantly longer progression-free survival and overall survival than chemotherapy among patients with advanced ...
Lenvatinib Plus Pembrolizumab Versus Chemotherapy in ...
The success of this combination therapy was observed in phase II studies, yielding an ORR of 38% in pMMR patients, significantly surpassing the ...
Toxicity and efficacy of the combination of pembrolizumab with ...
A lower starting dose of lenvatinib (14 mg daily) in combination with pembrolizumab was safe and efficacious in recurrent endometrial cancer.
Real-world clinical outcomes of lenvatinib in combination ...
INTRODUCTION: The KEYNOTE-775/Study-309 trial demonstrated statistically significantly improved outcomes with lenvatinib plus pembrolizumab (LEN+PEM) vs ...
KEYTRUDA® (pembrolizumab) Plus LENVIMA® ...
At five years, KEYTRUDA plus LENVIMA showed a 16.7% overall survival (OS) rate for these patients with mismatch repair proficient (pMMR) advanced ...
The efficacy and safety of the novel combination lenvatinib ...
The pooled objective response of endometrial cancer patients treated with Lenvatinib and Pembrolizumab was 36.5 % (95 % CI = 0.258–0.471), the ...
Lenvatinib Plus Pembrolizumab in Previously ... - PubMed
Lenvatinib plus pembrolizumab continued to show improved efficacy versus chemotherapy and manageable safety in patients with previously treated advanced EC.
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