35 Participants Needed

Pembrolizumab + Lenvatinib for Advanced Cervical Cancer

Recruiting at 2 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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

SK

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

I am fully active or restricted in physically strenuous activity but can do light work.
Absolute neutrophil count (ANC) ≥1500/µL
My organs are functioning well, tested within the last 28 days.
See 14 more

Exclusion Criteria

I have a history of Hepatitis B or active Hepatitis C.
I do not have serious heart problems like recent heart attacks or severe heart failure.
My brain metastases are stable, and I haven't needed steroids for 14 days.
See 22 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab and lenvatinib combination therapy. The treatment is administered in cycles, with each cycle lasting 21 days.

up to 2 years
Day 1 of each cycle (each cycle is 21 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of overall survival and progression-free survival.

up to 2 years
Every 12 weeks after end of treatment

Treatment Details

Interventions

  • Lenvatinib
  • Pembrolizumab
Trial Overview The trial tests pembrolizumab combined with lenvatinib in patients with advanced cervical cancer who didn't respond well to initial treatment. It's believed this combo could counteract VEGF-mediated immunosuppression and improve patient response.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab with LenvatinibExperimental Treatment2 Interventions

Lenvatinib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Lenvima for:
  • Differentiated Thyroid Cancer
  • Renal Cell Carcinoma
  • Hepatocellular Carcinoma
  • Endometrial Cancer
🇪🇺
Approved in European Union as Lenvima for:
  • Thyroid Cancer
  • Renal Cell Carcinoma
  • Hepatocellular Carcinoma
  • Endometrial Cancer
🇪🇺
Approved in European Union as Kisplyx for:
  • Renal Cell Carcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials
355
Recruited
142,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Findings from Research

In a study of 108 patients with advanced endometrial carcinoma, the combination of lenvatinib and pembrolizumab resulted in a 38% objective response rate at 24 weeks, with particularly high efficacy (63.6%) in patients with microsatellite instability (MSI)-high tumors.
The treatment demonstrated a median duration of response of 21.2 months and a median overall survival of 16.7 months, while the combination therapy had a manageable safety profile, with 66.9% of patients experiencing grade 3 or 4 treatment-related adverse events.
Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer.Makker, V., Taylor, MH., Aghajanian, C., et al.[2021]
In a study of 7 women with advanced or recurrent uterine carcinosarcoma (UCS) treated with pembrolizumab and lenvatinib, the combination therapy showed limited efficacy, with no observed partial or complete responses.
The median progression-free survival (PFS) was only 2.6 months and overall survival (OS) was 2.8 months, suggesting that this treatment may not be more effective than traditional chemotherapy options for UCS.
Lenvatinib plus pembrolizumab in patients with advanced or recurrent uterine carcinosarcoma.Hunt, JT., Chambers, LM., Yao, M., et al.[2022]
The combination of pembrolizumab and lenvatinib has shown promising efficacy in treating advanced endometrial cancer, with previous trials indicating improved objective response rates and survival outcomes compared to standard chemotherapy.
This ongoing phase 3 trial aims to determine if pembrolizumab plus lenvatinib is superior to the chemotherapy regimen of paclitaxel plus carboplatin in newly diagnosed patients, with a target enrollment of about 875 participants and results expected in 2022.
Phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer: ENGOT-en9/LEAP-001.Marth, C., Tarnawski, R., Tyulyandina, A., et al.[2022]

References

Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer. [2021]
Lenvatinib plus pembrolizumab in patients with advanced or recurrent uterine carcinosarcoma. [2022]
Phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer: ENGOT-en9/LEAP-001. [2022]
Tumor molecular profiling of responders and non-responders following pembrolizumab monotherapy in chemotherapy resistant advanced cervical cancer. [2020]
Immunotherapy and targeted therapy for cervical cancer: an update. [2016]
Adverse events and oncologic outcomes with combination lenvatinib and pembrolizumab for the treatment of recurrent endometrial cancer. [2023]
Optimizing the use of lenvatinib in combination with pembrolizumab in patients with advanced endometrial carcinoma. [2023]
Characterization and Management of Adverse Reactions in Patients With Advanced Endometrial Cancer Receiving Lenvatinib Plus Pembrolizumab. [2023]
Characterization and Management of Adverse Reactions in Patients with Advanced Endometrial Carcinoma Treated with Lenvatinib Plus Pembrolizumab. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Toxicity and efficacy of the combination of pembrolizumab with recommended or reduced starting doses of lenvatinib for treatment of recurrent endometrial cancer. [2022]
Phase II study of atezolizumab in combination with bevacizumab in patients with advanced cervical cancer. [2021]
Pembrolizumab for advanced cervical cancer: safety and efficacy. [2021]
Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer: an interim analysis of a multicentre, open-label, single-arm, phase 2 trial. [2020]
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