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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 72 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2810

Lenvatinib

2017

Completed Phase 4

~2040