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Tyrosine Kinase Inhibitor

Pembrolizumab + Lenvatinib for Solid Cancers

Phase 2
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
Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the specified cohorts
For Gastric Cancer Participants: Has received 2 prior lines of therapy. Note: Gastric cancer will include participants with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with squamous cell carcinoma histology are not eligible
Must not have
Has an active infection requiring systemic therapy
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment start
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 72 months
Awards & highlights

Summary

This trial will test a combination of two drugs to see if it is safe and effective for treating various types of cancer.

Who is the study for?
This trial is for adults with certain advanced solid tumors, including breast, ovarian, stomach, colorectal cancers and more. Participants must have tried standard treatments without success and meet specific criteria like organ function and performance status. Women of childbearing potential must agree to use contraception.
What is being tested?
The study tests the combination of two drugs: Pembrolizumab (an immunotherapy) and Lenvatinib (a targeted therapy), in patients with previously treated solid tumors. It aims to assess how safe this combo is and how well it works against different types of cancer.
What are the potential side effects?
Possible side effects include fatigue, high blood pressure, diarrhea, decreased appetite, weight loss, joint or muscle pain. More serious risks involve immune system complications that can affect organs like lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer cannot be surgically removed and standard treatments have failed.
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I have gastric cancer and have undergone two previous treatments.
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My condition worsened after my last treatment.
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I have triple-negative breast cancer, treated 1-2 times, normal LDH levels, and known hormone receptor status.
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I have had two treatments for my colorectal cancer.
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I have biliary tract cancer, received one prior treatment, and my liver is functioning well.
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I have ovarian cancer and have undergone 3 previous treatments.
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I have pancreatic cancer that has spread, and I've had 1-2 treatments including platinum or gemcitabine.
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I have provided a sample of my tumor for PD-L1 testing.
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My cancer can be measured using specific criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for an infection.
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I haven't had any cancer treatment or experimental drugs in the last 4 weeks.
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I have a serious wound or broken bone that isn't healing.
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I have been treated for an autoimmune disease in the last 2 years.
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I have been treated with specific cancer drugs like lenvatinib or immunotherapy before.
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I have a history of hepatitis B or currently have hepatitis C.
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I have had an organ or tissue transplant and need medicine to prevent rejection.
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My scans show no major blood vessel or heart involvement by the tumor.
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For participants with a type of brain cancer called GBM: You have cancer spread to the covering of the brain, a very large recurrent tumor, tumor mainly in the brainstem or spinal cord, cancer in multiple areas, bleeding around the tumor, or have used Optune® TTFields recently.
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I have another cancer that is getting worse or was treated in the last 3 years.
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I have a condition that affects how my body absorbs medication.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I have an active tuberculosis infection.
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I haven't had major heart problems like heart failure, heart attack, or stroke in the last year.
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I have had or currently have lung inflammation treated with steroids.
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My cancer has spread to my brain stem.
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I have active brain metastases or cancer in my brain's lining.
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I have a severe fistula in my GI tract or elsewhere.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 72 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 72 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ORR per RECIST 1.1 or RANO (GBM) by Blinded Independent Central Review (BICR) in Expanded Cohorts (Combined with Initial Cohorts)
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria for Glioblastoma (GBM) by Investigator Assessment in Initial Cohorts
Percentage of Participants Receiving Lenvatinib Monotherapy who Discontinue Study Treatment Due to an Adverse Event (AE)
+3 more
Secondary study objectives
DCR per RECIST 1.1 by BICR in Expanded Cohorts (Combined with Initial Cohorts)
DCR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm
DOR per RECIST 1.1 by BICR in Lenvatinib Monotherapy Arm
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pembrolizumab + Lenvatinib (Arm 1)Experimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years).
Group II: Lenvatinib Monotherapy (Arm 2)Experimental Treatment1 Intervention
Participants receive lenvatinib 24 mg via oral capsule QD, to be administered until progressive disease or unacceptable toxicity (up to at least 2 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2850
Lenvatinib
2017
Completed Phase 4
~2040

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,763 Total Patients Enrolled
18 Trials studying Breast Cancer
5,570 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,971 Previous Clinical Trials
5,177,217 Total Patients Enrolled
60 Trials studying Breast Cancer
7,420 Patients Enrolled for Breast Cancer
Eisai Inc.Industry Sponsor
520 Previous Clinical Trials
159,045 Total Patients Enrolled
17 Trials studying Breast Cancer
2,044 Patients Enrolled for Breast Cancer

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03797326 — Phase 2
Breast Cancer Research Study Groups: Pembrolizumab + Lenvatinib (Arm 1), Lenvatinib Monotherapy (Arm 2)
Breast Cancer Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT03797326 — Phase 2
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03797326 — Phase 2
~0 spots leftby Oct 2024