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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 72 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 72 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 72 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreTrial 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 2
~2010
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,238 Total Patients Enrolled
18 Trials studying Breast Cancer
5,570 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,963 Total Patients Enrolled
59 Trials studying Breast Cancer
7,534 Patients Enrolled for Breast Cancer
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,430 Total Patients Enrolled
17 Trials studying Breast Cancer
2,044 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 3 weeks.I agree to use contraception or avoid sex for 7 days after my last dose.I am currently being treated for an infection.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have fluid buildup needing drainage or medication, except if I have ovarian cancer.I have a serious wound or broken bone that isn't healing.I have been treated for an autoimmune disease in the last 2 years.You are allergic to lenvatinib or any of its ingredients.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I have been treated with specific cancer drugs like lenvatinib or immunotherapy before.I have not received a live vaccine in the last 30 days.You have been diagnosed with HIV in the past.I have a history of hepatitis B or currently have hepatitis C.I have had an organ or tissue transplant and need medicine to prevent rejection.I have GBM, failed my first treatment, am neurologically stable, and know my MGMT status.My scans show no major blood vessel or heart involvement by the tumor.I have had a blood clot in an artery in the past year.My advanced cancer cannot be surgically removed and standard treatments have failed.I have not had significant coughing up of blood or tumor bleeding in the last 2 weeks.I have gastric cancer and have undergone two previous treatments.I have another cancer that is getting worse or was treated in the last 3 years.My condition worsened after my last treatment.I had radiotherapy over 2 weeks ago, with no ongoing side effects.I have a condition that affects how my body absorbs medication.I have triple-negative breast cancer, treated 1-2 times, normal LDH levels, and known hormone receptor status.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.I have had two treatments for my colorectal cancer.I am not pregnant, breastfeeding, and if capable of bearing children, I agree to use contraception as required.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have biliary tract cancer, received one prior treatment, and my liver is functioning well.I haven't had biologic response modifiers therapy in the last 4 weeks.I have an active tuberculosis infection.I can perform all my usual activities without significant limitations.I haven't had major heart problems like heart failure, heart attack, or stroke in the last year.I have fully recovered from any major surgery before starting the study treatment.I have had or currently have lung inflammation treated with steroids.My cancer has spread to my brain stem.I have ovarian cancer and have undergone 3 previous treatments.My organs are functioning well.I have active brain metastases or cancer in my brain's lining.I have pancreatic cancer that has spread, and I've had 1-2 treatments including platinum or gemcitabine.I have provided a sample of my tumor for PD-L1 testing.My cancer can be measured using specific criteria.I have a severe fistula in my GI tract or elsewhere.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Lenvatinib (Arm 1)
- Group 2: Lenvatinib Monotherapy (Arm 2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current scope of participation for this experiment?
"Unfortunately, this clinical trial has ceased its search for patients. It was initially advertised on February 12th 2019 and last updated August 19th 2022. If you are searching for other research opportunities, there are currently 2790 trials recruiting participants with glioblastoma and 1032 using pembrolizumab as a treatment that are actively enrolling."
Answered by AI
Are there any precedent experiments that utilized Pembrolizumab?
"The initial pembrolizumab study was conducted in the City of Hope back in 2010. Since then, 302 studies have finished and over 1,000 are currently recruiting participants from Montreal and other locations."
Answered by AI
Are new participants being taken on for this research endeavor?
"Unfortunately, this clinical trial is not currently accepting new participants. It was originally posted on February 12th 2019 and has since been updated for the last time on August 19th 2022. For those looking for similar studies related to glioblastoma, there are 2790 trials recruiting; 1032 of them involve Pembrolizumab as a medication or intervention."
Answered by AI
Has the FDA provided clearance for Pembrolizumab?
"With Phase 2 data, our team at Power ranked the safety of Pembrolizumab as a 2 on a 1 to 3 scale. This is due to there being evidence in support of its safety but not yet any studies that prove efficacy."
Answered by AI
Are there a plethora of locations in the US that are hosting this experiment?
"Participants who are interested in this clinical trial have the option of enrolling at one of 16 sites across North America, including cities such as Montreal, Sioux Falls and Fargo. To reduce travel burdens it is advised to pick a location that is closest to you."
Answered by AI
What are the chief aims of this investigation?
"The primary aim of this research project, to be evaluated over 72 months at its maximum duration, is the percentage of participants receiving lenvatinib monotherapy who experience an adverse event. Secondary objectives include progression-free survival according to RECIST 1.1 or RANO (GBM) by BICR in expanded cohorts (combined with initial cohorts), PFS per RECIST 1.1 by BICR in lenvatinib monotherapy arm and overall response rate according to RECIST 1.1 by BICR in lenvatinib monotherapy arm.."
Answered by AI
What medical applications is Pembrolizumab most commonly used for?
"Pembrolizumab can be used to combat malignant neoplasms, unresectable melanomas, and cases of microsatellite instability high."
Answered by AI
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