Pembrolizumab +/− Lenvatinib for Head and Neck Cancer
(LEAP-10 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of drugs, pembrolizumab (an immunotherapy) and lenvatinib (a targeted therapy), to determine if they work better together than pembrolizumab alone for a specific type of head and neck cancer. Researchers aim to see if this combination can improve the cancer's response to treatment, slow its progression, and extend patients' lives. Participants should have recurrent or metastatic head and neck squamous cell carcinoma that cannot be cured with local therapies, with tumors in the oropharynx, oral cavity, hypopharynx, or larynx. This trial is not suitable for those allergic to the study drugs or who have certain other medical conditions. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not be on certain treatments like systemic steroids above a specific dose or have received certain therapies recently. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found that almost all patients (98.7%) who took both pembrolizumab and lenvatinib experienced treatment-related side effects. This combination has been tested for other conditions and is usually well-tolerated, though side effects are common. Common issues include high blood pressure, tiredness, and diarrhea. However, some patients reported overall improvement and noticed their cancer symptoms improved. Pembrolizumab is an approved treatment for several types of cancer, so its safety is well-known. Lenvatinib is also approved for other uses. Current studies are examining how these drugs work together, especially for head and neck cancer, so understanding of their combined safety is still developing.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about pembrolizumab combined with lenvatinib for head and neck cancer because it offers a unique approach compared to standard treatments like chemotherapy and radiation. Pembrolizumab is an immunotherapy that helps the immune system target and destroy cancer cells, while lenvatinib is a targeted therapy that inhibits the growth of blood vessels feeding tumors. This combination could enhance the body's ability to fight cancer more effectively. Unlike traditional treatments that often cause significant side effects, this regimen aims to provide a more precise and potentially less toxic option.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
Research has shown that using pembrolizumab and lenvatinib together can help patients with head and neck cancer. In this trial, one group of participants will receive this combination. Studies have found that this combination significantly increases the chance of the tumor shrinking or disappearing and delays the cancer from worsening. Specifically, one study found that 46% of patients experienced tumor shrinkage at 24 weeks, and the cancer did not worsen for an average of 4.7 months. However, this combination did not extend overall survival. These findings suggest that while the treatment may help control cancer growth, it might not increase life expectancy. Another group in this trial will receive pembrolizumab with a placebo, allowing researchers to compare the effectiveness of the combination treatment.23678
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma that can't be cured by surgery or radiation. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and have a certain level of physical ability (ECOG score 0-1). People who've had recent major surgery, live vaccines, other cancer treatments like pembrolizumab or similar drugs in the past are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab with or without lenvatinib as a first line intervention for up to 35 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Lenvatinib
- Pembrolizumab
- Placebo
Trial Overview
The study tests if combining Pembrolizumab with Lenvatinib improves response rates, slows disease progression, and extends survival compared to Pembrolizumab with a placebo. Participants will either receive both drugs or one drug plus a placebo without knowing which group they're in.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.
Participants receive lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months).
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?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead 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
Eisai Inc.
Industry Sponsor
Lynn Kramer
Eisai Inc.
Chief Medical Officer since 2019
MD
Tatsuyuki Yasuno
Eisai Inc.
Chief Executive Officer since 2023
MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University
Citations
Merck and Eisai Provide Update on Phase 3 LEAP-010 ...
Merck and Eisai are studying the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in ...
2.
cancernetwork.com
cancernetwork.com/view/pembrolizumab-lenvatinib-combo-shows-mixed-results-in-recurrent-metastatic-hnsccPembrolizumab/Lenvatinib Combo Shows Mixed Results ...
Combining lenvatinib (Lenvima) with pembrolizumab (Keytruda) significantly improved overall response rate (ORR) and progression-free survival (PFS) but not ...
Clinical Review - Pembrolizumab in Combination With ... - NCBI
The Health Canada–approved indication of interest for this review is PEM in combination with lenvatinib (LEN) for the treatment of adult patients with advanced ...
Lenvatinib Plus Pembrolizumab Fails to Improve Overall ...
The overall response rate at 24 weeks was 46%, with a median progression-free survival of 4.7 months. “These findings reinforce pembrolizumab ...
Results from clinical trials with KEYTRUDA + LENVIMA
View results from clinical trials with KEYTRUDA® (pembrolizumab) and LENVIMA® (lenvatinib). Select a type of cancer to see the results.
Merck and Eisai Provide Update on Phase 3 LEAP-012 ...
As reported previously, KEYTRUDA plus LENVIMA in combination with TACE met the study's other primary endpoint of progression-free survival (PFS) ...
KEYTRUDA® (pembrolizumab) Plus LENVIMA® ...
The safety profile of the KEYTRUDA plus LENVIMA combination was consistent with previously reported studies. Merck and Eisai will discuss these ...
LENVIMA® (lenvatinib) Plus KEYTRUDA® ...
Treatment-related adverse events (TRAEs) occurred in 98.7% of patients receiving LENVIMA plus KEYTRUDA in combination with TACE versus 84.6% of ...
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