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Tyrosine Kinase Inhibitor

Pembrolizumab +/− Lenvatinib for Head and Neck Cancer (LEAP-10 Trial)

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last

Has measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been showed in such lesions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 50 months

Awards & highlights

LEAP-10 Trial Summary

This trial is studying whether giving pembrolizumab with or without lenvatinib to people with cancer of the head and neck who have PD-L1 selection is better than giving pembrolizumab with placebo.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects such as inflammation of organs; skin reactions; liver issues; hormonal gland problems like thyroid disorders; and lung issues like pneumonitis. Lenvatinib might cause high blood pressure, fatigue, nausea, decreased appetite among others.

LEAP-10 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant, breastfeeding, and if able to bear children, I agree to use contraception as required.

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My cancer can be measured and has grown in previously treated areas.

Select...

My oropharyngeal cancer has been tested for HPV.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

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My head or neck cancer is newly diagnosed and at stage IV.

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My cancer is in my throat, mouth, or voice box.

Select...

I agree to use contraception or avoid sex for 7 days after my last dose.

Select...

My blood pressure is under control, with or without medication.

Select...

My head or neck cancer cannot be cured with surgery or radiation.

Select...

My organs are functioning well.

LEAP-10 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 50 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 50 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 50 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).

Overall Survival (OS)

Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).

Secondary outcome measures

Duration of Response (DOR)

Number of Participants Who Discontinued Study Drug Due to an AE

Number of Participants Who Experienced an Adverse Event (AE)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

LEAP-10 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab with LenvatinibExperimental Treatment2 Interventions

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.

Group II: Pembrolizumab with PlaceboActive Control2 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenvatinib

2005

Completed Phase 4

~2690

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,311 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,060 Total Patients Enrolled

Eisai Inc.Industry Sponsor

515 Previous Clinical Trials

153,509 Total Patients Enrolled

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04199104 — Phase 3

Head and Neck Squamous Cell Carcinoma Research Study Groups: Pembrolizumab with Lenvatinib, Pembrolizumab with Placebo

Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT04199104 — Phase 3

Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04199104 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being given the chance to participate in this test?

"Unfortunately, this particular clinical trial is not enrolling patients at the moment. The study was first posted on February 5th, 2020 and received its most recent update on August 1st, 2022. However, there are 2758 other trials for carcinoma, squamous cell and 1076 studies involving Pembrolizumab that are currently looking for test subjects."

Answered by AI

What is the short and long term safety profile of Pembrolizumab?

"Pembrolizumab has received a score of 3 for safety from our team at Power. This is because Pembrolizumab is in Phase 3 trials, meaning that there is both some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

What other Pembrolizumab research is available?

"There are presently 1076 clinical trials underway that involve Pembrolizumab with 134 of those in Phase 3. However, many people don't realize that there are 37362 total locations where these trials are taking place--not just Sacramento, California."

Answered by AI

Are new participants being sought for this experiment?

"This study has stopped recruiting patients. The trial was first posted on February 5th, 2020 and the latest update was on August 1st, 2022. If you are looking for other trials, there are currently 2758 studies actively searching for participants with carcinoma, squamous cell and 1076 studies for Pembrolizumab that need patients."

Answered by AI

For which type of cancer is Pembrolizumab most commonly prescribed?

"Pembrolizumab is most frequently given to patients with malignant neoplasms, but it can also be used to treat other conditions such as unresectable melanoma and microsatellite instability high."

Answered by AI

Recent research and studies

Future OncologyJournal

The LEAP Program: Lenvatinib Plus Pembrolizumab for the Treatment of Advanced Solid Tumors

Taylor, Matthew H, Emmett V Schmidt, Corina Dutcus, Elaine M Pinheiro, Yasuhiro Funahashi, Gregory Lubiniecki, and Drew Rasco. 2021. “The LEAP Program: Lenvatinib Plus Pembrolizumab for the Treatment of Advanced Solid Tumors”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2020-0937.

clinicaltrials.govStudy

A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010)

2020. "A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04199104.

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